NCT05884840 New Cardiovascular Risk Screening Strategy.
| NCT ID | NCT05884840 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina |
| Condition | Cardiovascular Prevention |
| Study Type | INTERVENTIONAL |
| Enrollment | 54,000 participants |
| Start Date | 2023-11-20 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 54,000 participants in total. It began in 2023-11-20 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Rafel Ramos Blanes, MD, PhD
PRINCIPAL INVESTIGATOR
Unidad de Investigación en Atención Primaria de Girona, IDIAP Jordi Gol
Frequently Asked Questions
Who can join the NCT05884840 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 74 Years, studying Cardiovascular Prevention. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05884840 currently recruiting?
Yes, NCT05884840 is actively recruiting participants. Contact the research team at rramos.girona.ics@gencat.cat for enrollment information.
Where is the NCT05884840 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT05884840 clinical trial?
NCT05884840 is sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina. The principal investigator is Rafel Ramos Blanes, MD, PhD at Unidad de Investigación en Atención Primaria de Girona, IDIAP Jordi Gol. The trial plans to enroll 54,000 participants.