New Cardiovascular Risk Screening Strategy.

Study Overview
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Brief Summary
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Mortality due to cardiovascular disease (CVD) in Spain accounted for 29% of all deaths (32% in women and 26% in men) in 2017. Out of those, 67% were related to a coronary or a cerebrovascular disease . A key strategy in primary prevention of CVD is to use risk functions to individualize preventive interventions for each patient. The current CV risk-screening program in some regions of Spain, is based using an adapted Framingham scale, REGICOR's risk function, which is integrated in the primary care electronic health record. This risk function predicts the probability within 10 years of developing a coronary event. However, this function fails to identify patients that fall into low- or intermediate-risk level, and might develop a CV event in the up following 10 years. Ankle-brachial index (ABI) is a simple, non-invasive and economic technique, which allows detecting peripheral arterial disease (PAD), and gives independent risk function information compared to other coronary risk functions. Even tough, between 13-27% of middle age population have an ABI ≤ 9, around 50-89% of them do not exhibit any symptoms. However, they hold higher mortality risk and CV events. Current clinical guidelines for PAD screening, have a limited level of evidence, and only recommend using ABI on patients aged 50-70, who have diabetes or are smokers, and patients older than 70 years old. A new risk function, REASON, to assess CVD risk has been designed. This model has proven to improve predictive capacity of holding an ABI ≤ 0.9 on those patients aged 50-74 that are apparently free of CVD. Therefore, a strategy that combines the current CV risk estimation using REGICOR, and the prediction capacity of pathologic ABI with REASON, would allow detecting high-risk patients with a PAD screening program. It is possible that patients, who hold an ABI ≤ 0.9, even if being asymptomatic, will adopt physician's recommendations on healthy life habits and preventive treatment. The aims of this study are: To assess the effectiveness and cost-utility of adding a screening program with ABI to the current strategy of CV risk detection to reduce the incidence of CVD and mortality from all causes in the population aged 50 to 74. To assess the effectiveness of adding a screening program with ABI to the current strategy of CV risk detection to improve cardiovascular risk factors in the population aged 50 to 74.

Official Title
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Health Program for prEvention of cardiovascuLar disEases Based on a Risk screeNing Strategy With Ankle-brachial Index.

Conditions
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Cardiovascular Prevention, Screening, Peripheral Artery Disease, Arteriosclerosis, Asymptomatic

Intervention / Treatment
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* Diagnostic Test: HELENA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 50 to 74, which are free or do not have previous history of CVD. Patients that hold a REGICOR CV risk score ≥7, and REASON risk core ≥7, during a routine primary care visit Exclusion Criteria: Symptomatic PAD Coronary disease Stroke Cardiac revascularization

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study will be conducted as a clustered randomized pragmatic clinical trial (CRT) in primary care practice. During the period of two years (2023-2025), randomization of the eight Health Regions (274 primary care centres) in Catalonia will take place. The current strategy, in Catalonia, for cardiovascular risk screening is based on risk assessment using Framingham-REGICOR risk function. In the intervention group, a screening program with ABI will be added to all 50-74-year-old individuals with Framingham-REGICOR risk ≥7% and high probability of having ABI≤0.9. The probability of having ABI≤0.9 will be estimated using the REASON function and will be defined as a probability ≥7%. People that are classified as ABI≤0.9 high-risk, will undergo a PAD screening program using ABI test. If the result of the ABI is equal and lower than 0.9, indications of the Health Catalan Institute's CV and lipid guidelines will be recommended by physicians to the patients.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group PAD screening program<br>Patients aged 50-74 years free of any symptomatic or history of CVD and a Framingham-REGICOR risk ≥7%, will be candidates for PAD screening program using REASON's function predicative capacity | Diagnostic Test: HELENA<br>* The current CV risk screening program in based using the REGICOR risk function, which is integrated in the primary care electronic health record. This risk function predicts the probability within 10 years of developing a coronary event. Those who are categorized as high risk, obtaining a 10% of probability, are candidates of receiving lipid lowering drugs and recommendations on healthy life habits. What this intervention suggests is that, besides the REGICOR estimation, the electronic health records will also incorporate a new CV risk function, REASON. The model predicts the risk of holding a pathologic ABI score, in people aged 50-74 years old who are apparently free of CV. Patients who obtain a score ≥ 7 will undergo a PAD screening program with ABI test. If the value of the test is ≤0.9, the REGICOR, physicians will recommend indications of the Health Catalan Institute's CV and lipid Guidelines to the patients.<br>|
| No Intervention: Control group PAD screening program<br>Patients aged 50-74 years free of any symptomatic or history of CVD will be candidates as a comparison group to calculate the cost-utility and reduction of CVD risk and events. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hard coronary heart disease (CHD) | Myocardial infarction, cardiac revascularization, or coronary death | 3 years | 
| Major adverse cardiovascular event (MACE) | A composite of hard CHD (myocardial infarction, cardiac revascularization, or coronary death) and stroke (fatal and nonfatal ischemic stroke) | 3 years | 
| All-cause mortality |  | 3 years | 
| Tabaco consumption (CVD risk factors improvement assessment) | Smoker, ex-smoker or non-smoker | 3 years | 
| Lipid profile (CVD risk factors improvement assessment) | Total cholesterol (mg/dl), LDL (mg/dl), HDL (mg/dl), Triglycerides (mg/dl) | 3 years | 
| Systolic and diastolic pressure (CVD risk factors improvement assessment) | mm Hg | 3 years | 
| Weight (CVD risk factors improvement assessment) | kg | 3 years | 
| Height (CVD risk factors improvement assessment) | m | 3 years | 
| BMI (CVD risk factors improvement assessment) | (kg/m2) Will be calculated dividing the weight in kilograms by their height in metres squared | 3 years | 
| Glycaemia (CVD risk factors improvement assessment) | Fasting blood sugar (mg/dl) | 3 years | 
| Glycated haemoglobin (CVD risk factors improvement assessment) | (in DM patients) glycosylated hemoglobin in the blood (mg/dl) or percentage (%) | 3 years | 
| Creatinine (CVD risk factors improvement assessment) | mg/dL | 3 years | 
| Proteinuria (CVD risk factors improvement assessment) | mg/dL protein in urine | 3 years | 
| Albumin-to-creatinine ratio (ACR) (CVD risk factors improvement assessment) | ACR (mg/g) will be calculated by by dividing mg of proteinuria (albumine) by g of creatinine. | 3 years | 
| Glomerular filtrate rate (CVD risk factors improvement assessment) | Levels of creatinine in milliliters of cleansed blood per minute per body surface (mL/min/1.73m2). | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary heart disease | A composite of angina and hard CHD | 3 years | 
| Cerebrovascular disease | A composite of stroke (fatal and nonfatal ischemic stroke) and transient ischemic attack | 3 years | 
| Cardiovascular disease | a composite of MACE, angina and transient ischemic attack | 3 years | 
| Lipid lowering medication Adverse effects | 1) Short-term effects: Muscular and hepatic alterations, and 2) long-term effects: Diabetes and cancer | 3 years |