Development of a set of mobile phone text messages designed for prevention of recurrent cardiovascular events IMProving Adherence using Combination Therapy (IMPACT): design and protocol of a randomised controlled trial in primary care. Design and rationale of the tobacco, exercise and diet messages (TEXT ME) trial of a text message-based intervention for ongoing prevention of cardiovascular disease in people with coronary disease: a randomised controlled trial protocol Leisure time physical activity and long-term cardiovascular and cancer outcomes: the Busselton Health Study Mediterranean diet and the incidence of cardiovascular disease: a Spanish cohort. A cardiovascular disease policy model that predicts life expectancy taking into account socioeconomic deprivation HEART: heart exercise and remote technologies: A randomized controlled trial study protocol The effects of Hartcoach, a life style intervention provided by telephone on the reduction of coronary risk factors: a randomised trial Lipoprotein(a) as a cardiovascular risk factor: current status Polypill for the prevention of cardiovascular disease (PolyIran): study design and rationale for a pragmatic cluster randomized controlled trial Prospective association of the Mediterranean diet with cardiovascular disease incidence and mortality and its population impact in a non-Mediterranean population: the EPIC-Norfolk study Cardiovascular disease risk reduction in rural China: a clustered randomized controlled trial in Zhejiang Dietary patterns and mortality from cardiovascular disease: Isfahan Cohort Study Reducing salt intake for prevention of cardiovascular diseases in high-risk patients by advanced health education intervention (RESIP-CVD study), Northern Thailand: study protocol for a cluster randomized trial Cardiovascular Outcomes in Action to Control Cardiovascular Risk in Diabetes: Impact of Blood Pressure Level and Presence of Kidney Disease Cardiovascular risk profile and outcome of patients with abdominal aortic aneurysm in out-patients with atherothrombosis: data from the Reduction of Atherothrombosis for Continued Health (REACH) Registry. World Salt Awareness Week. Statins for Primary Prevention: The Debate Is Intense, but the Data Are Weak. Higher Dietary Calcium Intakes Are Associated With Reduced Risks of Fractures, Cardiovascular Events, and Mortality: A Prospective Cohort Study of Older Men and Women. A randomised controlled trial of a consumer-focused e-health strategy for cardiovascular risk management in primary care: the Consumer Navigation of Electronic Cardiovascular Tools (CONNECT) study protocol Evaluating the use of mobile phone technology to enhance cardiovascular disease screening by community health workers Use of a Multidrug Pill In Reducing cardiovascular Events (UMPIRE): rationale and design of a randomised controlled trial of a cardiovascular preventive polypill-based strategy in India and Europe Study design of ASPirin in Reducing Events in the Elderly (ASPREE): a randomized, controlled trial.
Background : Supporting lifestyle change is an effective way of preventing recurrent events in people with cardiovascular disease ( CVD ) . However , there is a need to develop innovative strategies that increase access to programmes for individuals at high risk of CVD . This study aim ed to develop a bank of text messages design ed to provide advice , motivation , and support for decreasing cardiovascular risk . Design : Iterative development process with mixed methods Methods : An initial bank of 120 text messages was drafted based on behaviour change techniques , guidelines , and input from clinicians and public health experts . A question naire was then administered to participants ( n = 53 ) for evaluation of message content , usefulness , and language . To test the process of delivery , a pilot study was conducted using a specifically design ed computer programme that delivered messages to multiple mobile phones according to a pre-specified schedule . Data were collected regarding message timing , delivery , and usefulness . Results : In the qualitative question naire , 92 % of participants found the messages easy to underst and and 86 % found the messages contained useful information . Positive feedback was also obtained from the pilot study . Based on these results , together with suggestions provided , several messages were reworded and an additional 44 were written . The need for semi-personalization was also identified and a r and om set of 103 individualized messages was created . Conclusions : A final bank of 137 mobile telephone text messages design ed to support behaviour change and decrease cardiovascular risk have been developed through a multistep iterative process . This provides a scientific approach for future developers of health-related text messages BACKGROUND Cardiovascular disease ( CVD ) is the leading cause of death , and principal reason for the large difference in life expectancy between indigenous Māori and the non-indigenous population in New Zeal and . CVD guidelines recommend that people who are at high risk or who have had previous CVD should be offered aspirin , blood pressure lowering and lipid lowering therapies . However , prescribing and adherence rates are low and CVD events remain high . AIM To assess whether a medication strategy using a fixed dose combination pill ( ' polypill ' ) could improve prescribing and adherence to recommended medications , lower blood pressure and improve lipids compared with current care over 12 months . METHODS IMProving Adherence using Combination Therapy ( IMPACT ) is an open-label r and omised controlled trial comparing a once-daily polypill containing four preventive medications with usual care .  Six hundred participants who have had previous CVD events or are at high risk of CVD will be enrolled , including 300 Māori . Participants are identified , enrolled and prescribed either the polypill or current medications at their usual primary health care practice , with medications ( including the polypill ) dispensed through local community pharmacies . The polypill contains 75 mg aspirin , 40 mg simvastatin , 10 mg lisinopril and either 12.5 mg hydrochlorothiazide or 50 mg atenolol . Primary outcomes are adherence to guidelines -recommended medications and changes in systolic blood pressure and low density lipoprotein at 12 months . Secondary outcomes include other lipids , medication dispensing , barriers to adherence , CVD and other serious adverse events , quality of life and prescriber acceptability . The trial is registered with the Australian New Zeal and Clinical Trial Registry ( ACTRN12606000067572 ) Background Although supporting lifestyle change is an effective way of preventing further events in people with cardiovascular disease , providing access to such interventions is a major challenge . This study aims to investigate whether simple reminders about behaviour change sent via mobile phone text message decrease cardiovascular risk . Methods and analysis R and omised controlled trial with 6 months of follow-up to evaluate the feasibility , acceptability and effect on cardiovascular risk of repeated lifestyle reminders sent via mobile phone text messages compared to usual care .  A total of 720 patients with coronary artery disease will be r and omised to either st and ard care or the TEXT ME intervention . The intervention group will receive multiple weekly text messages that provide information , motivation , support to quit smoking ( if relevant ) and recommendations for healthy diets and exercise . The primary end point is a change in plasma low-density lipoprotein cholesterol at 6 months . Secondary end points include a change in systolic blood pressure , smoking status , quality of life , medication adherence , waist circumference , physical activity levels , nutritional status and mood at 6 months . Process outcomes related to acceptability and feasibility of TEXT ME will also be collected . Ethics and dissemination Primary ethics approval was received from Western Sydney Local Health Network Human Research Ethics Committee — Westmead . Results will be disseminated via the usual scientific forums including peer- review ed publications and presentations at international conferences . Clinical trials registration number ACTRN12611000161921 Abstract The study aim ed to investigate whether meeting leisure time physical activity recommendations was associated with reduced incident and fatal cancer or cardiovascular disease ( CVD )  in a community-based cohort of middle- to late-aged adults with long-term follow-up . At baseline , 2,320 individuals were assessed on a large number of lifestyle and clinical parameters including their level of physical activity  per week , other risk factors ( e.g. smoking and alcohol use ) various anthropometric measures , blood tests and medical history . Individuals were linked to hospital and mortality registry data to identify future cancer and cardiovascular events ( fatal and non-fatal ) out to 15 years of follow-up . Cox regression analyses adjusted for relevant confounders identified a priori were used to estimate risk for all-cause , cancer-specific and CVD-specific mortality . In the full cohort an estimated 21 % decreased risk for all-cause mortality ( HR 0.79 ; 95 % CI 0.66–0.96 ) and 22 % decreased risk for fatal/non-fatal CVD events ( HR 0.78 ; 95 % CI 0.66–0.92 ) was associated with baseline self-reported physical activity levels of 150 min or more . After exclusion of those with chronic co-morbidities ( CVD , cancer , diabetes , chronic obstructive pulmonary disease , hypertension treatment ) at baseline , lower risk for fatal/non-fatal CVD events remained significantly associated with 150 min or more of physical activity ( HR 0.77 ; 95 % CI 0.62–0.96 ) . Results from this well established prospect i ve community-based cohort study support the role of leisure time physical activity in reducing all-cause mortality and CVD events ( fatal/nonfatal ) in the broader population studied . The data also suggest that physical activity associated reductions in risk for CVD events ( fatal/nonfatal ) were not overly impacted by prevalent key non-communicable diseases BACKGROUND AND AIM The Mediterranean diet is considered a model for healthy eating . However , prospect i ve evidence in Mediterranean countries evaluating the relationship between this dietary pattern and non-fatal cardiovascular events is scarce . The aim of the present study was to evaluate the association between the adherence to the Mediterranean diet and the incidence of fatal and non-fatal cardiovascular events among initially healthy middle-aged adults from the Mediterranean area . METHODS AND RESULTS We followed-up 13,609 participants ( 60 percent women , mean age : 38 years ) initially free of cardiovascular disease ( CVD ) during 4.9 years . Participants were part of a prospect i ve cohort study of university graduates from all regions of Spain .  Baseline diet  was assessed using a vali date d 136-item food-frequency question naire . A 9-point score was used to appraise adherence to the Mediterranean diet . Incident clinical events were confirmed by a review of medical records . We observed 100 incident cases of CVD . In multivariate analyses , participants with the highest adherence to the Mediterranean diet ( score>6 ) exhibited a lower cardiovascular risk ( hazard ratio=0.41 , 95 % confidence interval [ CI ] : 0.18 - 0.95 ) compared to those with the lowest score ( <3 ) . For each 2-point increment in the score , the adjusted hazard ratios were 0.80 ( 95 % CI : 0.62 - 1.02 ) for total CVD and 0.74 ( 0.55 - 0.99 ) for coronary heart disease . CONCLUSIONS There is an inverse association between adherence to the Mediterranean diet and the incidence of fatal and non-fatal CVD in initially healthy middle-aged adults Objectives A policy model is a model that can evaluate the effectiveness and cost-effectiveness of interventions and inform policy decisions . In this study , we introduce a cardiovascular disease ( CVD ) policy model which can be used to model remaining life expectancy including a measure of socioeconomic deprivation as an independent risk factor for CVD . Design A state transition model was developed using the Scottish Heart Health Extended Cohort ( SHHEC ) linked to Scottish morbidity and death records . Individuals start in a CVD-free state and can transit to three CVD event states plus a non-CVD death state . Individuals who have a non-fatal first event are then followed up until death . Taking a competing risk approach , the cause-specific hazards of a first event are modelled using parametric survival analysis . Survival following a first non-fatal event is also modelled parametrically . We assessed discrimination , validation and calibration of our model . Results Our model achieved a good level of discrimination in each component ( c-statistics for men (women)—non-fatal coronary heart disease ( CHD ) : 0.70 ( 0.74 ) , non-fatal cerebrovascular disease ( CBVD ) : 0.73 ( 0.76 ) , fatal CVD : 0.77 ( 0.80 ) , fatal non-CVD : 0.74 ( 0.72 ) , survival after non-fatal CHD : 0.68 ( 0.67 ) and survival after non-fatal CBVD : 0.65 ( 0.66 ) ) . In general , our model predictions were comparable with observed event rates for a Scottish r and omised statin trial population which has an overlapping follow-up period with SHHEC . After applying a calibration factor , our predictions of life expectancy closely match those published in recent national life tables . Conclusions Our model can be used to estimate the impact of primary prevention interventions on life expectancy and can assess the impact of interventions on inequalities Background Cardiovascular disease ( CVD ) is the leading cause of death worldwide . Cardiac rehabilitation ( CR ) is aim ed at improving health behaviors to slow or reverse the progression of CVD disease . Exercise is a central element of CR . Technologies such as mobile phones and the Internet ( mHealth ) offer potential to overcome many of the psychological , physical , and geographical barriers that have been associated with lack of participation in exercise-based CR . We aim to trial the effectiveness of a mobile phone delivered exercise-based CR program to increase exercise capacity and functional outcomes compared with usual CR care in adults with CVD . This paper outlines the rationale and methods of the trial . Methods A single-blinded parallel two-arm r and omized controlled trial is being conducted . A total of 170 people will be r and omized at 1:1 ratio either to receive a  mHealth CR program  or usual care .  Participants are identified by CR nurses from two metropolitan hospitals in Auckl and , New Zeal and through outpatient clinics and existing data bases . Consenting participants are contacted to attend a baseline assessment . The intervention consists of a theory-based , personalized , automated package of text and video message components via participants ' mobile phones and the Internet to increase exercise behavior , delivered over six months . The control group will continue with usual CR . Data collection occurs at baseline and 24 weeks ( post-intervention ) . The primary outcome is change in maximal oxygen uptake from baseline to 24 weeks . Secondary outcomes include post-intervention measures on self-reported physical activity ( IPAQ ) , cardiovascular risk factors ( systolic blood pressure , weight , and waist to hip ratio ) , health related quality of life ( SF-36 ) , and cost-effectiveness . Discussion This manuscript presents the protocol for a r and omized controlled trial of a mHealth exercise-based CR program . Results of this trial will provide much needed information about physical and psychological well-being , and cost-effectiveness of an automated telecommunication intervention . If effective , this intervention has enormous potential to improve the delivery of CR and could easily be scaled up to be delivered nationally ( and internationally ) in a very short time , enhancing the translational aspect of this research . It also has potential to extend to comprehensive CR ( nutrition advice , smoking cessation , medication adherence).Trial Registration Background Cardiovascular disease ( CVD ) is the leading cause of death worldwide . Secondary prevention is essential , but participation rates for cardiac rehabilitation are low . Furthermore , current programmes do not accomplish that patients with CVD change their lifestyle in a way that their individual risk factors for recurrent events decrease , therefore more effective interventions are needed . In this study , the effectiveness of the Hartcoach-programme , a telephonic secondary prevention program focussing on self management , is studied . Methods / design A multicenter , r and omised parallel-group study is being conducted . Participants are 400 patients with acute myocardial infa rct ion ( STEMI , NSTEMI , ) and patients with chronic or unstable angina pectoris ( IAP ) . Patients are recruited through the participating hospitals and r and omly assigned to the experimental group ( Hartcoach-programme plus usual care ) or the control group ( usual care).The Hartcoach-programme consists of a period of six months during which the coach contacts the patient every four to six weeks by telephone . Coaches train patients to take responsibility for the achievement and maintenance of the defined target levels for their particular individual modifiable risk factors . Target levels and treatment goals are agreed by the nurse and patient together . Data collection is blinded and occurs at baseline and after 26 weeks ( post-intervention ) . Primary outcome is change in cardiovascular risk factors ( cholesterol , body mass index , waist circumference , blood pressure , physical activity and diet ) . Secondary outcomes include chances in glucose , HbA1c , medication adherence , self-management and quality of life . Discussion This study evaluates the effects of the Hartcoach-programme on the reduction of individual risk factors of patients with CVDs . Patients who are not invited to follow a hospital based rehabilitation programme or patients who are unable to adhere to such a programme , may be reached by this home based Hartcoach-programme . If positive results are found , the implementation of the Hartcoach-programme will be extended , having implication s for the management of many people with CVD.Trial registration Aims The aims of the study were , first , to critically evaluate lipoprotein(a ) [ Lp(a ) ] as a cardiovascular risk factor and , second , to advise on screening for elevated plasma Lp(a ) , on desirable levels , and on therapeutic strategies . Methods and results The robust and specific association between elevated Lp(a ) levels and increased cardiovascular disease (CVD)/coronary heart disease ( CHD ) risk , together with recent genetic findings , indicates that elevated Lp(a ) , like elevated LDL-cholesterol , is causally related to premature CVD/CHD . The association is continuous without a threshold or dependence on LDL- or non-HDL-cholesterol levels . Mechanistically , elevated Lp(a ) levels may either induce a prothrombotic/anti-fibrinolytic effect as apolipoprotein(a ) resembles both plasminogen and plasmin but has no fibrinolytic activity , or may accelerate atherosclerosis because , like LDL , the Lp(a ) particle is cholesterol-rich , or both . We advise that Lp(a ) be measured once , using an isoform-insensitive assay , in subjects at intermediate or high CVD/CHD risk with premature CVD , familial hypercholesterolaemia , a family history of premature CVD and /or elevated Lp(a ) , recurrent CVD despite statin treatment , ≥3 % 10-year risk of fatal CVD according to European guidelines , and /or ≥10 % 10-year risk of fatal + non-fatal CHD according to US guidelines . As a secondary priority after LDL-cholesterol reduction , we recommend a desirable level for Lp(a ) < 80th percentile ( less than ∼50 mg/dL ) . Treatment should primarily be niacin 1–3 g/day , as a meta- analysis of r and omized , controlled intervention trials demonstrates reduced CVD  by niacin treatment . In extreme cases , LDL-apheresis is efficacious in removing Lp(a ) . Conclusion We recommend screening for elevated Lp(a ) in those at intermediate or high CVD/CHD risk , a desirable level < 50 mg/dL as a function of global cardiovascular risk , and use of niacin for Lp(a ) and CVD/CHD risk reduction Background The complexity of treatment regimens , costs and pill burden decrease the medication adherence and contribute to shortfall in cardiovascular preventive drug coverage . The polypill , a fixed dose combination pill of established drugs , is expected to increase adherence and reduce the costs whilst preventing major cardiovascular events ( MCVE ) . Design and methods The PolyIran trial is a pragmatic cluster r and omized trial nested within the Golestan Cohort Study ( GCS ) . Subjects were r and omized to either non-pharmacological preventive interventions alone ( minimal care arm ) or together with a polypill ( polypill arm ) comprising hydrochlorothiazide , aspirin , atorvastatin and either enalapril or valsartan . This study benefits from the infrastructure of the primary health care system in Iran and the interventions are delivered by the local auxiliary health workers ( Behvarz ) to the participants . The primary outcome of the study is the occurrence of first MCVE within five years defined as non-fatal and fatal myocardial infa rct ion , unstable angina , sudden death , heart failure , coronary artery revascularization procedures , and non-fatal and fatal stroke . Trial status From February 2011 to April 2013 , 8410 individuals ( 236 clusters ) attended the eligibility assessment . Of those , 3421 in the polypill arm and 3417 in the minimal care arm were eligible . The study is ongoing . Conclusion The infrastructure of GCS and the primary health care system in Iran enabled the conduct of this pragmatic large-scale trial . If the polypill strategy proves effective , it may be implemented to prevent cardiovascular disease in developing countries Background Despite convincing evidence in the Mediterranean region , the cardiovascular benefit of the Mediterranean diet is not well established in non-Mediterranean countries and the optimal criteria for defining adherence are unclear . The population attributable fraction ( PAF ) of adherence to this diet is also unknown . Methods In the UK-based EPIC-Norfolk prospect i ve cohort , we evaluated habitual diets assessed at baseline ( 1993–1997 ) and during follow-up ( 1998–2000 ) using food-frequency question naires  ( n = 23,902 ) . We estimated a Mediterranean diet score ( MDS ) using cut-points projected from the Mediterranean dietary pyramid , and also three other pre-existing MDSs . Using multivariable-adjusted Cox regression with repeated measures of MDS and covariates , we examined prospect i ve associations between each MDS with incident cardiovascular diseases ( CVD ) by 2009 and mortality by 2013 , and estimated PAF for each outcome attributable to low MDS . Results We observed 7606 incident CVD events ( 2818/100,000 person-years ) and 1714 CVD deaths ( 448/100,000 ) . The MDS based on the Mediterranean dietary pyramid was significantly associated with lower incidence of the cardiovascular outcomes , with hazard ratios ( 95 % confidence intervals ) of 0.95 ( 0.92–0.97 ) per one st and ard deviation for incident CVD and 0.91 ( 0.87–0.96 ) for CVD mortality . Associations were similar for composite incident ischaemic heart disease and all-cause mortality . Other pre-existing MDSs showed similar , but more modest associations . PAF due to low dietary pyramid based MDS ( < 95th percentile ) was 3.9 % ( 1.3–6.5 % ) for total incident CVD and 12.5 % ( 4.5–20.6 % ) for CVD mortality . Conclusions Greater adherence to the Mediterranean diet was associated with lower CVD incidence and mortality  in the UK . This diet has an important population health impact for the prevention of CVD Background Cardiovascular disease ( CVD ) is a major cause of death in China . Despite government efforts , the majority of hypertensive and diabetic patients in China do not receive proper treatment . Reducing CVD events requires long-term care that is proactive , patient-centred , community-based , and sustainable . We have design ed a package of interventions for patients at high risk of CVD to be implemented by family doctors based in township hospitals ( providers of primary care ) in rural Zhejiang , China . This trial aims to determine whether the systematic CVD risk reduction package results in reduced CVD events among patients at risk of CVD compared with usual care , and whether the package is cost-effective and suitable for routine implementation and scale-up . Methods / Design This is a prospect i ve , open-label , cluster r and omized controlled trial ( RCT ) with blinded data analysis . The trial will r and omize 67 township hospitals with 31,708 participants in three counties in Zhejiang Province . Participants will be identified from existing health records and will comprise adults aged 50 to 74 years , with a calculated 10-year CVD risk of 20 % or higher , or diabetes . In the intervention arm , participants will receive a package of interventions including : 1 ) healthy lifestyle counseling ( smoking cessation , and salt , oil , and alcohol reduction ) ; 2 ) prescription of a combination of drugs ( antihypertensives , aspirin , and statin ) ; and 3 ) adherence support for drug compliance and healthy lifestyle change . In the control arm , participants will receive usual care for hypertension and diabetes management at individual clinicians ’ discretion . The primary outcome is the incidence of severe CVD events over 24 months of follow-up . All CVD events will be defined according to the World Health Organization ( WHO ) monitoring of trends and determinants in cardiovascular disease ( MONICA ) definitions , diagnosed at the county hospital or higher level , and reported by the Zhejiang surveillance system . Secondary outcomes include : mean systolic and diastolic blood pressure , blood glucose , serum total cholesterol ( TC ) , and adherence to appointments , and drugs and lifestyle changes . Discussion This trial focuses on risk reduction of CVD rather than specific diseases . It is not design ed to compare therapeutic and healthy lifestyle interventions , but rather their combined effects in primary care setting s. Through the trial , we intend to underst and the effectiveness of the comprehensive CVD reduction package in routine practice . We also intend to underst and the barriers and facilitators to implementing the package , and thus to advise on policy and practice change . Trial registration Current Controlled Trials : IS RCT Background / Objectives : Evidence about the relation between dietary patterns and cardiovascular disease ( CVD ) is scarce in Middle Eastern countries . This study was performed to examine the association between major dietary patterns and  CVD mortality in Iranian adults . Subjects/ Methods : This population -based prospect i ve cohort study was conducted among 4834 r and omly selected participants aged ⩾35 years from urban and rural areas of central Iran ( 2001–2009 ) ( the Isfahan Cohort Study ) .  Dietary intakes were assessed using a food frequency question naire , and major dietary patterns were identified by means of exploratory factor analysis . Subjects or their next of kin were interviewed biannually looking for possible occurrence of events . Cardiovascular mortality was defined as fatal myocardial infa rct ion , fatal stroke and sudden cardiac death . Results : During the median follow-up of 9.0 years and 50 282 person-years , we found a total of 118 CVD mortalities . Four major dietary patterns were identified : ' Western ' , ' Mediterranean ' , ' Animal fat ' and ' Fast food ' . Adherence to the Mediterranean dietary pattern was protectively associated with CVD mortality , such that those in the highest quartile were 46 % ( hazard ratio ( HR ) : 0.54 ; 95 % confidence interval ( CI ) : 0.32–0.91 ; P-value for trend=0.03 ) less likely to have incident CVD mortality than those in the lowest quartile . Further adjustment for potential confounders strengthened this association ( HR : 0.42 ; 95 % CI : 0.19–0.96 ; P-value for trend=0.02 ) . We found no significant association between adherence to the Western , animal fat and fast food dietary patterns and CVD mortality . Conclusions : Adherence to a Mediterranean dietary pattern was associated with reduced risk for cardiovascular mortality even in a developing country setting Background Decreasing salt consumption can prevent cardiovascular diseases ( CVD ) . Practically , it is difficult to promote people ’s awareness of daily salt intake and to change their eating habits in terms of reducing salt intake for better cardiovascular health . Health education programs visualizing daily dietary salt content and intake may promote lifestyle changes in patients at high risk of cardiovascular diseases . Methods / Design This is a cluster r and omized trial . A total of 800 high-CVD-risk patients attending diabetes and hypertension clinics at health centers in Muang District , Chiang Rai province , Thail and , will be studied with informed consent . A health center recruiting 100 participants is a cluster , the unit of r and omization . Eight clusters will be r and omized into intervention and control arms and followed up for 1 year . Within the intervention clusters the following will be undertaken : ( 1 )  salt content in the daily diet will be measured and shown to study participants ; ( 2 )  24-hour salt intake will be estimated in overnight-collected urine and the results shown to the participants ; ( 3 ) a dietician will assist small group health education classes in cooking meals with less salt . The primary outcome is blood pressure change at the 1-year follow-up . Secondary outcomes at the 1-year follow-up are estimated 24-hoursalt intake , incidence of CVD events and CVD death . The intention-to-treat analysis will be followed . Blood pressure and estimated 24-hour salt intake will be compared between intervention and control groups at the cluster and individual level at the 1-year follow-up . Clinical CVD events and deaths will be analyzed by time-event analysis . Retinal blood vessel calibers of CVD-risk patients will be assessed cross-sectionally . Behavioral change to reduce salt intake and the influencing factors will be determined by structured equation model ( SEM ) . Multilevel regression analyses will be applied . Finally , the cost effectiveness of the intervention will be analyzed . Discussion This study is unique as it will recruit the individuals most vulnerable to CVD morbidity and mortality by applying the general Framingham CVD risk scoring system . Dietary salt reduction will be applied as a prioritized , community level intervention for the prevention of CVD in a developing country . Trial registration IS RCT Background : Persons with chronic kidney disease ( CKD ) represent a population prone to cardiovascular disease ( CVD ) but vulnerable to adverse medication effects . We assessed the impact of intensive antihypertensive therapy on the cerebrovascular and other CVD outcomes in high-risk patients with type 2 diabetes and baseline CKD . Methods : Using current guideline criteria , 1,726 ( 36.9 % ) of 4,678 participants in the Action to Control Cardiovascular Risk in Diabetes ( ACCORD ) blood pressure ( BP ) arm had mild to moderate CKD ( CKD1 - 3B ) at baseline . Participants of this study were r and omized to intensive ( systolic < 120 mm Hg ) or st and ard ( systolic < 140 mm Hg ) BP goals . Fatal and non-fatal stroke were pre-specified secondary outcomes of the ACCORD study . Results : Total cerebrovascular events were significantly higher in participants with baseline CKD ( 0.66%/year ) compared with participants free of CKD ( 0.28%/year ) . A significantly higher rate of events was observed in CKD participants . Intensive antihypertensive therapy in participants without CKD at baseline result ed in a 55 % significant reduction of any stroke ( hazard ratio 0.447 ; 95 % CI 0.227 - 0.880 ) and a 50 % reduction of non-fatal stroke ( hazard ratio 0.498 ; 95 % CI 0.250 - 0.993 ) . In participants with CKD at baseline , the occurrence of any stroke was reduced by 38 % ( hazard ratio 0.623 ; 95 % CI 0.361 - 1.074 ) and non-fatal stroke by 36 % ( hazard ratio 0.642 ; 95 % CI 0.361 - 1.142 ) . Test for interaction was NS between the 2 groups . Changes in other CVD outcomes did not reach statistical significance . Conclusions : These findings suggest that intensive antihypertensive therapy offers significant cerebrovascular protection in diabetic participants without CKD at baseline , but significant benefit to patients with CKD can not be excluded OBJECTIVE Data sets regarding patients with abdominal aortic aneurysm ( AAA ) have almost universally been restricted to single geographic regions . We aim ed to obtain data on the risk factor profile and cardiovascular ( CV ) co-morbidity among multi-ethnic patients with known AAA in the global REACH ( REduction of Atherothrombosis for Continued Health ) Registry . METHODS The REACH Registry is an international , prospect i ve , observational out-patient registry enrolling out- patients > /=45 years of age with established coronary artery disease ( CAD ) , cerebrovascular disease ( CVD ) or peripheral arterial disease ( PAD ) or with at least three atherothrombotic risk factors . This report includes observations pertaining to 68,236 out- patients enrolled in 44 countries . MAIN OUTCOME MEASURES Gender , ethnic origin , CV risk factors , established atherosclerotic disease ( CAD , CVD and PAD ) at baseline , and CV outcome events at 1-year were compared in patients with and without AAA . RESULTS An AAA was reported in 1722 ( 2.5 % ) of 68,236 out- patients enrolled in the REACH Registry . Older age ( 73 + /- 8 vs 68 + /- 10 , P < .0001 ) , male gender ( 81 % vs 63 % , P < .0001 ) , White ethnicity ( 79 % vs 67 % , P < .0001 ) and a history of smoking ( 81 % vs 55 % , P < .0001 ) were independently related to the diagnosis of AAA . There was a weaker association with hypertension or hypercholesterolemia , and an inverse relation with diabetes . Fatal and non-fatal coronary and cerebrovascular event rates were not different between the AAA and non-AAA cohorts , but individuals with AAA suffered increased rates of other cardiovascular deaths ( 1.39 % vs 0.94 % , P = .0135 ) , hospitalizations for atherothrombotic events ( 14.1 % vs 9.3 % , P < .0001 ) due to increased rates of revascularization procedures , and new or worsening PAD ( 3.7 % vs 1.3 % , P < .0001 ) at 1-year follow-up . CONCLUSION This study , the largest published to date , presents the CV risk profile and outcome of patients with an established diagnosis of AAA from a cohort of patients with either overt manifestations of CV disease or multiple risk factors , and further defines these patients in a multi-ethnic , global context Cardiovascular disease ( CVD ) , including stroke , heart attack and heart failure , is the leading cause of death and disability worldwide . Raised blood pressure ( BP ) is a major cause of CVD , responsible for 62 % of stroke and 49 % of coronary heart disease cases . There is much evidence for a causal relationship between salt intake and BP . The current salt intake in many countries around the world is between 9 g ⁄d and 12 g ⁄d ( ie , 3.6–4.8 g of sodium ) . R and omized trials have demonstrated that a modest reduction in salt intake lowers BP in individuals with raised BP and also in those with ‘ ‘ normal ’ ’ BP . Furthermore , there is a dose-response relationship . Within the range of 12 g ⁄d to 3 g ⁄d , the lower the salt intake , the lower the BP . Because raised BP throughout its range is a major cause of CVD , salt reduction would reduce cardiovascular risk . It was estimated that a reduction of 6 g ⁄d in salt intake would reduce stroke by 24 % and coronary heart disease by 18 % . This would prevent approximately 35,000 stroke and coronary heart disease deaths a year in the United Kingdom and approximately 2.5 million deaths worldwide . Both prospect i ve studies and outcome trials have demonstrated that a lower salt intake is related to a reduced risk of CVD .  Salt reduction is one of the most cost-effective interventions to reduce CVD in both developed and developing countries . For example , the UK salt reduction campaign , which result ed in a fall in salt intake by approximately 10 % ( ie , from 9.5 g ⁄d in 2003 to 8.6 g ⁄d by May 2008 ) , cost just £ 15 million and led to approximately 6000 fewer CVD deaths per year , saving the UK economy approximately £ 1.5 billion per annum according to the recent report by the UK government ’s health advisory agency , the National Institute for Health and Clinical Excellence . In most developed countries , approximately 80 % of salt consumed is added to foods at the stage of manufacturing , and the consumers have no say over how much salt is added . Therefore , to achieve a reduction in population salt intake , it is imperative that the food industry make a gradual and sustained reduction in the amount of salt that is added to all foods . This approach has been successful in the United Kingdom and is now being exp and ed worldwide . World Salt Awareness Week was introduced by the salt reduction action group World Action on Salt and Health ( WASH ) in 2008 . The event serves as a platform for international experts in the fields of hypertension and nephrology to raise the profile of the importance of salt reduction to both the public and health professionals worldwide This issue of JAMA contains the latest US Preventive Services Task Force ( USPSTF ) recommendation statement on statins for prevention of cardiovascular disease in adults,1 along with the accompanying evidence report and systematic review 2 on which the recommendations are based . The evidence report summarized data from 19 trials including a total of 71 344 patients and concluded that statin therapy was associated with reduced risk of all-cause and cardiovascular mortality and cardiovascular disease ( CVD ) events . Thus , the task force recommended “ initiating use of lowto moderate-dose statins in adults aged 40 to 75 years without a history of CVD who have 1 or more CVD risk factors and a calculated 10-year CVD event risk of 10 % or greater ( B recommendation ) ” or “ 7.5 % to 10 % ( C recommendation ) .”1 Although the task force did their usual careful job of review ing the evidence , the evidence for treating asymptomatic persons with statins does not appear to merit a grade B or even a grade C recommendation . The task force evidence report estimated an absolute benefit for use of statins of 0.40 % for all-cause mortality and 0.43 % for cardiovascular mortality and indicated that the absolute benefit was greater for patients at greater baseline risk.2 Notably , the evidence report did not exclude studies that included patients taking statins for secondary prevention , who have a higher baseline risk of cardiac events and death and thus are more likely to benefit from therapy that inflates the benefit attributed to a primary prevention population . The task force did perform a sensitivity analysis that excluded 3 trials with persons for whom there were prior “ hard ” cardiovascular events and obtained similar results of benefits ( eTable 5 in the article by Chou et al2 ) . This sensitivity analysis did not exclude WOSCOPS , which included patients receiving statins for secondary prevention—5 % had angina and 3 % had intermittent claudication,3 accounting for 15 % of the total weight in the meta- analysis . In contrast , a meta- analysis of 11 studies and 65 229 patients receiving statins for primary prevention , in which patients receiving statins for secondary prevention were excluded , found no benefit of statins for reducing all-cause mortality.4 The confidence intervals of these 2 analyses overlap , and the difference between these findings likely reflects differences in studies included . The USPSTF and authors of the evidence report did not have access to the primary data ( clinical study reports and anonymized patient-level data ) from the statin clinical trials . Rather , they had to rely on peer- review ed published reports as the basis for these recommendations . Exacerbating the potential bias , all of the trials included in the task force evidence report2 were industry-sponsored except 1 trial,5 and that trial contributed 0.2 % of the weight to the mortality calculation . Industry-sponsored studies have been shown to report greater benefit and lesser adverse effects than noncommercially sponsored trials of the same drugs.6 Whether this is true for statins and primary prevention of CVD is unknown . Among the 19 r and omized clinical trials of statins vs placebo or no statin included in the evidence report for the task force recommendations , only 15 reported all-cause mortality , 10 reported cardiovascular mortality , 12 reported fatal and nonfatal myocardial infa rct ion  , and 13 reported fatal and nonfatal stroke.2,7  Reliance on selective reporting of the most important outcomes , which are likely included in the clinical trial data , makes reporting bias possible . Furthermore , after allcause mortality , the comparative incidence of serious adverse events between treatment and control groups is arguably the second most important measure of the effect of active therapy in r and omized clinical trials . Underst and ing the evidence base in evaluating harms of statin therapy is also critically important . Although the benefits of any preventive therapy accrue according to risk of disease ( greater benefit in higher-risk patients ) , the harms of therapy usually distribute equally over all risk levels . Thus , persons at low risk have little chance of benefit but equal chance of harms and thus are more likely to have a net harm . The evidence base for harms of statins , despite the introduction of these drugs more than 20 years ago , is incomplete . Many of the trials did not ask about commonly reported statin effects , such as muscle pains and weakness , and only recorded myopathy , for which an increase in creatine kinase levels was required . Because most muscle problems do not involve an increase in creatine kinase levels , this leads to a significant underestimate of muscle problems . Other studies have estimated that closer to 20 % of statin users have muscle problems.8 Additionally , the actual trial data are largely held by the Cholesterol Treatment Trialists ’ Collaboration on behalf of the industry sponsor and have not been made available to other research ers , despite multiple requests over many years.9 Although reported rates of adverse events in clinical trials are low , this does not reflect the experience of clinicians who see patients who are taking statins . For instance , the experience of an NPR reporter with a calculated 2.9 % risk of heart disease over 10 years using the recommended American College of Cardiology/American Heart Association ( ACC/AHA ) risk calculator,10 but still prescribed a statin , and experiencing adverse effects from the medication , is typical of what many Related articles at jama.com The aim of this population -based , prospect i ve cohort study was to investigate long-term associations between dietary calcium intake  and fractures , non-fatal cardiovascular disease ( CVD ) , and death from all causes . Participants were from the Melbourne Collaborative Cohort Study , which was established in 1990 to 1994 . A total of 41,514 men and women ( ∼99 % aged 40 to 69 years at baseline ) were followed up for a mean ( SD ) of 12 ( 1.5 ) years . Primary outcome measures were time to death from all causes ( n = 2855 ) , CVD-related deaths ( n = 557 ) , cerebrovascular disease-related deaths ( n = 139 ) , incident non-fatal CVD ( n = 1827 ) , incident stroke events ( n = 537 ) , and incident fractures ( n = 788 ) . A total of 12,097 participants ( aged ≥50 years ) were eligible for fracture analysis and 34,468 for non-fatal CVD and mortality analyses .  Mortality was ascertained by record linkage to registries . Fractures and CVD were ascertained from interview ∼13 years after baseline . Quartiles of baseline energy-adjusted calcium intake from food were estimated using a food-frequency question naire . Hazard ratios ( HR ) and odds ratios ( OR ) were calculated for quartiles of dietary calcium intake . Highest and lowest quartiles of energy-adjusted dietary calcium intakes represented unadjusted means ( SD ) of 1348 ( 316 ) mg/d and 473 ( 91 ) mg/d , respectively . Overall , there were 788 ( 10.3 % ) incident fractures , 1827 ( 9.0 % ) incident CVD , and 2855 people ( 8.6 % ) died . Comparing the highest with the lowest quartile of calcium intake , for all-cause mortality , the HR was 0.86 ( 95 % confidence interval [ CI ] 0.76 - 0.98 , p(trend ) = 0.01 ) ; for non-fatal CVD and stroke , the OR was 0.84 ( 95 % CI 0.70 - 0.99 , p(trend ) = 0.04 ) and 0.69 ( 95 % CI 0.51 - 0.93 , p(trend ) = 0.02 ) , respectively ; and the OR for fracture was 0.70 ( 95 % CI 0.54 - 0.92 , p(trend ) = 0.004 ) . In summary , for older men and women , calcium intakes of up to 1348 ( 316 ) mg/d from food were associated with decreased risks for fracture , non-fatal CVD , stroke , and all-cause mortality Introduction Fewer than half of all people at highest risk of a cardiovascular event are receiving and adhering to best practice recommendations to lower their risk . In this project , we examine the role of an e-health-assisted consumer-focused strategy as a means of overcoming these gaps between evidence and practice . Consumer Navigation of Electronic Cardiovascular Tools ( CONNECT ) aims to test whether a consumer-focused e-health strategy provided to Aboriginal and Torres Strait Isl and er and non-indigenous adults , recruited through primary care , at moderate-to-high risk of a cardiovascular disease event will improve risk factor control when compared with usual care . Methods and analysis R and omised controlled trial of 2000 participants with an average of 18 months of follow-up to evaluate the effectiveness of an integrated consumer-directed e-health portal on cardiovascular risk compared with usual care in patients with cardiovascular disease or who are at moderate-to-high cardiovascular disease risk . The trial will be augmented by formal economic and process evaluations to assess acceptability , equity and cost-effectiveness of the intervention . The intervention group will participate in a consumer-directed e-health strategy for cardiovascular risk management . The programme is electronically integrated with the primary care provider 's software and will include interactive smart phone and Internet platforms . The primary outcome is a composite endpoint of the proportion of people meeting the Australian guideline -recommended blood pressure ( BP ) and cholesterol targets . Secondary outcomes include change in mean BP and fasting cholesterol levels , proportion meeting BP and cholesterol targets separately , self-efficacy , health literacy , self-reported point prevalence abstinence in smoking , body mass index and waist circumference , self-reported physical activity and self-reported medication adherence . Ethics and dissemination Primary ethics approval was received from the University of Sydney Human Research Ethics Committee and the Aboriginal Health and Medical Research Council . Results will be disseminated via the usual scientific forums including peer- review ed publications and presentations at international conferences Clinical Trials registration number ACTRN12613000715774 BACKGROUND Primary prevention of cardiovascular disease (CVD),by identifying individuals at risk is a well-established , but costly strategy when based on measurements that depend on laboratory analyses . A non-laboratory , paper-based CVD risk assessment chart tool has previously been developed to make screening more affordable in developing countries . Task shifting to community health workers ( CHWs ) is being investigated to further scale CVD risk screening . This study aim ed to develop a mobile phone CVD risk assessment application and to evaluate its impact on CHW training and the duration of screening for CVD in the community by CHWs . METHODS A feature phone application was developed using the open source online platform , CommCare ( © ) . CHWs ( n=24 ) were trained to use both paper-based and mobile phone CVD risk assessment tools . They were r and omly allocated to using one of the risk tools to screen 10 - 20 community members and then crossed over to screen the same number , using the alternate risk tool . The impact on CHW training time , screening time and margin of error in calculating risk scores was recorded . A focus group discussion evaluated experiences of CHWs using the two tools . RESULTS The training time was 12.3h for the paper-based chart tool and 3h for the mobile phone application . 537 people were screened . The mean screening time was 36 min ( SD=12.6 ) using the paper-base chart tool and 21 min ( SD=8.71 ) using the mobile phone application , p=<0.0001 . Incorrect calculations ( 4.3 % of average systolic BP measurements , 10.4 % of BMI and 3.8 % of CVD risk score ) were found when using the paper-based chart tool while all the mobile phone calculations were correct . Qualitative findings from the focus group discussion corresponded with the findings of the pilot study . CONCLUSION The reduction in CHW training time , CVD risk screening time , lack of errors in calculation of a CVD risk score and end user satisfaction when using a mobile phone application , has implication s in terms of adoption and sustainability of this primary prevention strategy to identify people with high CVD risk who can be referred for appropriate diagnoses and treatment The use of preventive medications in people at high risk of cardiovascular disease is conceptually straightforward , yet in practice the adoption of such measures is disappointingly low , plus there is wide international variation in preventive therapies . Several barriers might explain this shortfall and variation , but the simplicity and economy of a polypill-based strategy might overcome some barriers . The ‘ Use of a Multidrug Pill In Reducing cardiovascular Events ’ ( UMPIRE ) trial assesses whether a polypill strategy ( by combining aspirin , a statin and two blood pressure lowering agents ) would improve adherence to guideline -indicated therapies and would lower both blood pressure and cholesterol , in people with established cardiovascular disease . UMPIRE , running in India and three European countries ( Engl and , Irel and and the Netherl and s ) , is an open , r and omised , controlled trial design ed to include 1000 participants in India and 1000 in Europe , with a followup of 12–24 months . Participants were r and omised to one of two versions of the polypill or relegated to usual care . The primary study outcomes were the self-reported use of aspirin , a statin and at least two blood pressure lowering agents ; as well as changes in blood pressure and cholesterol . Secondary outcomes included : any cardiovascular events , reasons for stopping medications , serious adverse events and perceived changes in quality of life . Interpretation of the study data will be enhanced by health , economic and process-related evaluations . UMPIRE is registered with the European Clinical Trials data base , as EudraCT : 2009 - 016278 - 34 and the Clinical Trials Registry , India as CTRI/2010/091/000250 . The trial was part of the ‘ Single Pill Against Cardiovascular Events ( SPACE ) ’ collaboration , which encompasses the ‘ IMProving Adherence using Combination Therapy ( IMPACT ) ’ and ‘ Kanyini Guidelines Adherence with the Polypill ( Kanyini-GAP ) ’ trials Cost-effective strategies to maintain healthy active lifestyle in aging population s are required to address the global burden of age-related diseases . ASPREE will examine whether the potential primary prevention benefits of low dose aspirin outweigh the risks in older healthy individuals . Our primary hypothesis is that daily oral 100 mg enteric-coated aspirin will extend a composite primary endpoint termed ' disability-free life ' including onset of dementia , total mortality , or persistent disability in at least one of the Katz Activities of Daily Living in 19,000 healthy participants aged 65 years and above ( ' US minorities ' ) and 70 years and above ( non-'US minorities ' ) . ASPREE is a double-blind , r and omized , placebo-controlled trial of oral 100 mg enteric-coated acetyl salicylic acid ( ASA ) or matching placebo being conducted in Australian and US community setting s on individuals free of dementia , disability and cardiovascular disease ( CVD ) events . Secondary endpoints are all-cause and cause specific mortality , fatal and non-fatal cardiovascular events , fatal and non-fatal cancer ( excluding non-melanoma skin cancer ) , dementia , mild cognitive impairment , depression , physical disability , and clinical ly significant bleeding .  To 20 September 2013 14,383 participants have been recruited . Recruitment and study completion are anticipated in July 2014 and December 2018 respectively . In contrast to other aspirin trials that have largely focused on cardiovascular endpoints , ASPREE has a unique composite primary endpoint to better capture the overall risk and benefit of aspirin to extend healthy independent lifespan in older adults in the US and Australia
While the results of this systematic review are promising , there is insufficient evidence to draw conclusions on the effectiveness of text message-based interventions for adherence to medications for secondary prevention of CVD .
BACKGROUND Worldwide at least 100 million people are thought to have prevalent cardiovascular disease ( CVD ) .
This population has a five times greater chance of suffering a recurrent cardiovascular event than people without known CVD .
Secondary CVD prevention is defined as action aim ed to reduce the probability of recurrence of such events .
Drug interventions have been shown to be cost-effective in reducing this risk and are recommended in international guidelines .
However , adherence to recommended treatments remains sub-optimal .
In order to influence non-adherence , there is a need to develop scalable and cost-effective behaviour-change interventions .
OBJECTIVES To assess the effects of mobile phone text messaging in patients with established arterial occlusive events on adherence to treatment , fatal and non-fatal cardiovascular events , and adverse effects .