Cardiovascular Screening for Family Members of People With Acute Coronary Disease: A Patient-Initiated and Family-Oriented Strategy
Phase: NA
Conditions: Cardiovascular Risk Factor
Sponsor: Lady Davis Institute

Cardiovascular Screening for Family Members of People with Acute Coronary Disease: A 
Patient-Initiated and Family-Oriented Strategy 
PI: Dr. Michael Goldfarb 
 
 
Study Protocol 
 
Patient Identification and Recruitment 
The prospective study will be conducted at the Jewish General Hospital (JGH), an 
academic tertiary care referral centre in Montreal, Quebec. The JGH’s acute care cardiovascular 
unit has 16 beds equipped for advanced hemodynamic and ventilator support and 32 ward beds 
with continuous telemetry. An outpatient cardiology clinic is adjacent to the inpatient unit. 
Patients admitted to the JGH over a 12-month period will be assessed for eligibility into 
the study by a member of the research team. Inclusion criteria are patient age ≤70 years old 
admitted with an initial diagnosis of an acute coronary event, such as acute coronary syndrome 
or myocardial infarction, and at least 1 first-degree family or household member age ≥ 18 years 
old. Exclusion criteria are no eligible family or household members, inability to contact family or 
household members, distance to study centre too far as determined by the patient, or family or 
household members who have been screened for CV disease in the previous 2 years. Family or 
household members with known coronary disease will also be excluded. 
Household members of the patient will be included in the study. There is evidence that 
partners and other non-genetically related household members, who do not have the same 
hereditary predisposition as the patient with CV disease, share social and lifestyle influences 
such as smoking habits, low physical activity, and diet, and have higher rates of CV disease than 
would be expected.1 
Younger relatives (≥18 years old) of the CV patient will be included as well. Younger 
relatives (typically under age 30) have been excluded from most prior screening studies.2 The 
optimal screening and management strategy for younger relatives of CAD patients is unclear. 
Early risk factor assessment and counselling of younger patients may promote lifelong changes 
in lifestyle choices and behaviours with long-term benefits.3  
Eligible patients will be given a letter containing instructions for the eligible family 
and/or household members on how to be referred for the initial screening visit and information 
about the importance of CV disease primary prevention (Appendix A). If there has been no 
contact from an eligible family or household member two weeks following the CV patient’s 
hospital discharge, a member of the healthcare team will contact the CV patient by phone to 
remind him or her to contact eligible family or household members. 
Informed consent for participation in the study will be obtained from the patient at the 
time of enrolment during index hospitalization and other participants at the time of the initial 
screening visit. Institutional research ethics approval will be obtained for this study. 
 
 

Cardiovascular Screening for Family Members of People with Acute Coronary Disease: A 
Patient-Initiated and Family-Oriented Strategy 
PI: Dr. Michael Goldfarb 
 
 
Risk Factor Screening and Treatment 
An appointment will be offered within two to four weeks of the patient’s hospitalization 
in order to maximize the motivation of family members who are willing to undergo screening. 
Prior to the initial visit, participants will receive blood test requisitions for a baseline complete 
blood count, electrolytes, creatinine, lipid profiles, hemoglobin A1c, fasting blood glucose 
levels, liver enzymes, and creatine kinase. At the initial screening visit, a targeted history and 
physical exam will be performed by a cardiologist and investigations will be ordered as needed. 
CV primary prevention assessment will follow the Canadian Cardiovascular Society’s 
recommendations.4 Weight and body-mass index will be recorded and blood pressure will be 
checked with the BPtru machine (BpTRU Medical Devices, Coquitlam, BC) in accordance to the 
Hypertension Canada’s guidelines.5 A modified 10-year Framingham risk score will be 
calculated.4 In patients ≤ 30 years old, a 30-year Framingham risk score will also be obtained. 
Physical activity will be measured using the Paffenbarger physical activity questionnaire 
(Appendix B) and reported in kilocalories of energy expenditure per day (kcal/d).6 A nutrition 
questionnaire (Food Frequency Questionnaire) will be administered (Appendix C). Identified CV 
risk factors will lead to appropriate evidence-based, society-recommended management.4, 5 
Participants will be referred to nutritionists, smoking cessation programs, and to other allied 
healthcare professionals as needed. The results of the risk assessment will be shared with the 
participant in order to support shared decision making, which has been shown to improve the 
likelihood that patients will achieve target lipid levels.4 If the participant has a primary care 
physician, the physician will be sent a letter explaining the screening findings and treatment plan.  
Participants will have a follow-up visit at 6-months during which they will undergo a 
history and physical exam and have lipid and glucose blood tests drawn. The Paffenbarger 
physical activity scale, Food Frequency Questionnaire, and an Information Assessment Method 
questionnaire (see section A3) will be administered. Interim follow-up appointments (maximum 
2 per participant) may be scheduled if needed. At the 6-month visit, participants will receive an 
individualized report of CV risk factor control and their change in 10-year modified CV risk. 
Reports will be sent to the primary care physician if applicable. Participants without primary care 
physicians will be given resources on how to register for one.  
The patient with coronary disease and all participating family and household members 
will be encouraged to attend the initial screening visit and all subsequent healthcare interactions. 
The history and physical exam will be done without other participants present in order to 
preserve confidentiality. Patients who accompany their family and household members to the 
appointments will also be encouraged to take their secondary preventive medications and 
continue follow-up with their treating physician, since half of patients who have a myocardial 
infarction stop taking their evidence-based preventative medications within 12 months of the 
index event.7 
 
 

Cardiovascular Screening for Family Members of People with Acute Coronary Disease: A 
Patient-Initiated and Family-Oriented Strategy 
PI: Dr. Michael Goldfarb 
 
 
Assessment of Participant Comprehension and Engagement in Care 
At the 6-month clinic visit, the Information Assessment Method (IAM), a self-
administered 1-page questionnaire (Appendix C), will be distributed to participants (patients, 
family members, and household members). The IAM is will be used to systematically evaluate 
the (1) acquisition and relevance of new information, (2) practical impact, (3) expected health 
benefits, and (4) associated barriers or facilitators.8, 9 Using a mixed-methods approach, we will 
review the IAM responses to understand the factors associated with the referral and screening 
program and to generate recommendations and feedback to the participants. The IAM is 
considered a knowledge translation tool by the Canadian Institute for Health Research.10 
 
Data Collection 
A research assistant will be based in the Division of Cardiology at the JGH and will have 
a dedicated space in the clinical research department with a computer-equipped workstation. The 
research assistant will be responsible for obtaining informed consent and extracting data from the 
patient record. 
From the patient, we will collect the following data: age, sex, ethnicity, willingness to 
refer family members and reasoning, whether CV screening was done prior to hospitalization, 
CV risk factors (including family history of CV disease), description of the acute coronary event, 
cardiac unit and hospital length of stay, and approximate number of eligible family or household 
members. 
From the family or household members, we will collect the following data: age, sex, 
gender, ethnicity, relationship with CV patient, whether the patient has a primary care physician 
and last time seen, CV symptoms on history, medications, weight, BP Tru recording, physical 
examination findings, physical activity, nutrition, and other CV risk factors identified (i.e., 
obstructive sleep apnea). Baseline and 6-month CV individual risk factor values will be recorded 
(i.e., blood pressure, lipid levels, HbA1c), as well as baseline and 6-month modified 
Framingham 10-year risk scores. A 30-year Framingham risk score will be recorded at baseline 
and 6-months for patients who are under age 30 at the time of study enrolment. Results from the 
IAM, nutrition, and physical activity at the 6-month visit will also be collected.  
 
Measures 
 
The effectiveness of the screening strategy will be measured by the total number of 
participants identified at intermediate or high risk on the modified Framingham CV risk score 
(>10% risk of a CV event over the following 10-year period). The effectiveness of the primary 
prevention intervention will be measured by the change in percentage of the mean modified 
Framingham 10-year CV risk score for family and household members between the initial visit 
and 6-month follow-up. The most recent Canadian Cardiovascular Society guidelines strongly 
recommend CV risk assessment using the modified Framingham 10-year risk score to guide 
therapy and to repeat the risk assessment when there is an expected change in risk status.4  
 
 
 

Cardiovascular Screening for Family Members of People with Acute Coronary Disease: A 
Patient-Initiated and Family-Oriented Strategy 
PI: Dr. Michael Goldfarb 
 
 
Data Analysis 
Results will be stratified by age (<65; ≥65) and sex. Continuous data will be presented as 
mean with standard deviation or median with interquartile range and between group differences 
will be tested with the Student’s t test and the Mann-Whitney U test, respectively. Categorical 
data will be presented as frequencies and percentages and will be compared using the chi-
squared test or the Fisher exact test, as appropriate. All p values will be two-sided with values ≤ 
0.05 indicating statistical significance. Statistical tests will be done using the SPSS 24.0 
statistical software (IBM Corp, Armonk, New York). Statistical analysis will be performed by 
statisticians affiliated with the Lady Davis Institute for Medical Research (Montreal, Quebec). 
 
References 
1. 
Kardia SL, Modell SM and Peyser PA. Family-centered approaches to understanding and 
preventing coronary heart disease. American Journal of Preventive Medicine. 2003;24:143-51. 
2. 
Goldfarb M, Slobod D, Dufresne L, Brophy JM, Sniderman A and Thanassoulis G. 
Screening Strategies and Primary Prevention Interventions in Relatives of People With Coronary 
Artery Disease: A Systematic Review and Meta-analysis. Can J Cardiol. 2015;31:649-57. 
3. 
Montgomery AA, Fahey T, Ben-Shlomo Y and Harding J. The influence of absolute 
cardiovascular risk, patient utilities, and costs on the decision to treat hypertension: a Markov 
decision analysis. Journal of Hypertension. 2003;21:1753-9. 
4. 
Anderson TJ, Grégoire J, Pearson GJ, Barry AR, Couture P, Dawes M, Francis GA, 
Genest J, Jr., Grover S, Gupta M, Hegele RA, Lau DC, Leiter LA, Lonn E, Mancini GBJ, 
McPherson R, Ngui D, Poirier P, Sievenpiper JL, Stone JA, Thanassoulis G and Ward R. 2016 
Canadian Cardiovascular Society Guidelines for the Management of Dyslipidemia for the 
Prevention of Cardiovascular Disease in the Adult. Canadian Journal of Cardiology. 32:1263-
1282. 
5. 
Leung AA, Nerenberg K, Daskalopoulou SS, McBrien K, Zarnke KB, Dasgupta K, 
Cloutier L, Gelfer M, Lamarre-Cliche M, Milot A, Bolli P, Tremblay G, McLean D, Tobe SW, 
Ruzicka M, Burns KD, Vallee M, Prasad GV, Lebel M, Feldman RD, Selby P, Pipe A, Schiffrin 
EL, McFarlane PA, Oh P, Hegele RA, Khara M, Wilson TW, Penner SB, Burgess E, Herman RJ, 
Bacon SL, Rabkin SW, Gilbert RE, Campbell TS, Grover S, Honos G, Lindsay P, Hill MD, 
Coutts SB, Gubitz G, Campbell NR, Moe GW, Howlett JG, Boulanger JM, Prebtani A, 
Larochelle P, Leiter LA, Jones C, Ogilvie RI, Woo V, Kaczorowski J, Trudeau L, Petrella RJ, 
Hiremath S, Drouin D, Lavoie KL, Hamet P, Fodor G, Gregoire JC, Lewanczuk R, Dresser GK, 
Sharma M, Reid D, Lear SA, Moullec G, Gupta M, Magee LA, Logan AG, Harris KC, Dionne J, 
Fournier A, Benoit G, Feber J, Poirier L, Padwal RS and Rabi DM. Hypertension Canada's 2016 
Canadian Hypertension Education Program Guidelines for Blood Pressure Measurement, 
Diagnosis, Assessment of Risk, Prevention, and Treatment of Hypertension. Can J Cardiol. 
2016;32:569-88. 
6. 
Paffenbarger  RSJ, Hyde  R, Wing  AL and Hsieh  C-c. Physical Activity, All-Cause 
Mortality, and Longevity of College Alumni. N Engl J Med. 1986;314:605-613. 
7. 
Choudhry NK, Avorn J, Glynn RJ, Antman EM, Schneeweiss S, Toscano M, Reisman L, 
Fernandes J, Spettell C, Lee JL, Levin R, Brennan T and Shrank WH. Full coverage for 
preventive medications after myocardial infarction. N Engl J Med. 2011;365:2088-97. 

Cardiovascular Screening for Family Members of People with Acute Coronary Disease: A 
Patient-Initiated and Family-Oriented Strategy 
PI: Dr. Michael Goldfarb 
 
8. 
Pluye P, Grad RM, Johnson-Lafleur J, Bambrick T, Burnand B, Mercer J, Marlow B and 
Campbell C. Evaluation of email alerts in practice: Part 2. Validation of the information 
assessment method. Journal of Evaluation in Clinical Practice. 2010;16:1236-43. 
9. 
Pluye P, Granikov V, Bartlett G, Grad RM, Tang DL, Johnson-Lafleur J, Shulha M, 
Barbosa Galvao MC, Ricarte IL, Stephenson R, Shohet L, Hutsul JA, Repchinsky CA, 
Rosenberg E, Burnand B, Legare F, Dunikowski L, Murray S, Boruff J, Frati F, Kloda L, 
Macaulay A, Lagarde F and Doray G. Development and content validation of the information 
assessment method for patients and consumers. JMIR Research Protocols. 2014;3:e7. 
10. 
Information Technology Primary Care Research Group. The Information Assessment 
Method. Department of Family Medicine, McGill University. http://www.mcgill.ca/iam. 
Accessed October 20, 2017.