New strategy for screening cardiovascular risk
Health Program for prEvention of cardiovascuLar disEases Based on a Risk screeNing Strategy With Ankle-brachial Index.
This study is testing a new way to spot heart disease risk in people aged 50 to 74 by using a simple test on their ankles and arms to see if it helps find those who might be at risk for problems like peripheral artery disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54000 (estimated) |
| Ages | 50 Years to 74 Years |
| Sex | All |
| Sponsor | Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT05884840 on ClinicalTrials.gov |
What this trial studies
This study aims to improve cardiovascular disease (CVD) prevention by implementing a new screening strategy that utilizes the Ankle-Brachial Index (ABI) to identify patients at risk for peripheral artery disease (PAD). The current screening method in Spain, based on the REGICOR risk function, may overlook individuals at low or intermediate risk who could still develop CVD. By integrating ABI measurements into routine primary care visits, the study seeks to provide a more accurate assessment of cardiovascular risk. The goal is to enhance early detection and intervention for patients aged 50 to 74 without a history of CVD.
Who should consider this trial
Good fit: Ideal candidates are patients aged 50 to 74 with a REGICOR CV risk score of 7 or higher, who have no previous history of cardiovascular disease.
Not a fit: Patients with symptomatic peripheral artery disease, coronary disease, stroke, or those who have undergone cardiac revascularization will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better identification and prevention of cardiovascular events in at-risk patients.
How similar studies have performed: Other studies have shown promise in using ABI for cardiovascular risk assessment, suggesting that this approach could be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Barcelona
- Institut Català de la Salut (ICS) — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Rafel Ramos Blanes, MD, PhD — Unidad de Investigación en Atención Primaria de Girona, IDIAP Jordi Gol
- Study coordinator: Rafel Ramos Blanes, MD, PhD
- Email: rramos.girona.ics@gencat.cat
- Phone: +34 972 48 79 68
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.