An interventional study of HELENA in Cardiovascular Prevention, Screening and Peripheral Artery Disease, sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina. Recruiting at 1 site in Spain. Open to participants aged 50 Years to 74 Years. Per ClinicalTrials.gov, last updated 2023-12-29.
Sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Not applicable, Interventional, and Prevention
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:
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's planned enrollment of 54,000 is above the median of 70 across 927 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina is the lead sponsor of 161 studies on the registry; 21 are open to participants now.
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Exclusion Criteria:
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
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.
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.
Hard coronary heart disease (CHD)
Myocardial infarction, cardiac revascularization, or coronary death
Time frame: 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)
Time frame: 3 years
All-cause mortality
Time frame: 3 years
Tabaco consumption (CVD risk factors improvement assessment)
Smoker, ex-smoker or non-smoker
Time frame: 3 years
Lipid profile (CVD risk factors improvement assessment)
Total cholesterol (mg/dl), LDL (mg/dl), HDL (mg/dl), Triglycerides (mg/dl)
Time frame: 3 years
Systolic and diastolic pressure (CVD risk factors improvement assessment)
mm Hg
Time frame: 3 years
Weight (CVD risk factors improvement assessment)
kg
Time frame: 3 years
Height (CVD risk factors improvement assessment)
m
Time frame: 3 years
BMI (CVD risk factors improvement assessment)
(kg/m2) Will be calculated dividing the weight in kilograms by their height in metres squared
Time frame: 3 years
Glycaemia (CVD risk factors improvement assessment)
Fasting blood sugar (mg/dl)
Time frame: 3 years
Glycated haemoglobin (CVD risk factors improvement assessment)
(in DM patients) glycosylated hemoglobin in the blood (mg/dl) or percentage (%)
Time frame: 3 years
Creatinine (CVD risk factors improvement assessment)
mg/dL
Time frame: 3 years
Proteinuria (CVD risk factors improvement assessment)
mg/dL protein in urine
Time frame: 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.
Time frame: 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).
Time frame: 3 years
Coronary heart disease
A composite of angina and hard CHD
Time frame: 3 years
Cerebrovascular disease
A composite of stroke (fatal and nonfatal ischemic stroke) and transient ischemic attack
Time frame: 3 years
Cardiovascular disease
a composite of MACE, angina and transient ischemic attack
Time frame: 3 years
Lipid lowering medication Adverse effects
1) Short-term effects: Muscular and hepatic alterations, and 2) long-term effects: Diabetes and cancer
Time frame: 3 years
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