HELENA: New Cardiovascular Risk Screening Strategy.

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05884840

Collaborator

Hospital del Mar Research Institute (IMIM) (Other), Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (Other), Institut Català de la Salut (Other), Biocruces Bizkaia Health Research Institute (Other)

54,000

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Prevention Screening Peripheral Artery Disease Arteriosclerosis Asymptomatic	Diagnostic Test: HELENA	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

54000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2026

Anticipated Study Completion Date :

Jun 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group PAD screening program 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 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.
No Intervention: Control group PAD screening program 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.

Arm

Intervention/Treatment

Experimental: Intervention group PAD screening program

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

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.

No Intervention: Control group PAD screening program

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 74 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Hospital del Mar Research Institute (IMIM)
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Institut Català de la Salut
Biocruces Bizkaia Health Research Institute

Investigators

Principal Investigator: Rafel Ramos Blanes, MD, PhD, Unidad de Investigación en Atención Primaria de Girona, IDIAP Jordi Gol

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

ClinicalTrials.gov Identifier:

NCT05884840

Other Study ID Numbers:

SLT/21/000015

First Posted:

Jun 1, 2023

Last Update Posted:

Jun 1, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Peripheral Arterial Disease

Arteriosclerosis

Study Results

No Results Posted as of Jun 1, 2023