Actively Recruiting
New Cardiovascular Risk Screening Strategy.
Led by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Updated on 2023-12-29
54000
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
Sponsors
F
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Lead Sponsor
H
Hospital del Mar Research Institute (IMIM)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
New Cardiovascular Risk Screening Strategy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 50 to 74 years
- No previous history of cardiovascular disease
- REGICOR cardiovascular risk score of 7 or higher
- REASON risk score of 7 or higher
- Identified during a routine primary care visit
You will not qualify if you...
- Symptomatic peripheral artery disease
- Coronary disease
- Stroke
- Previous cardiac revascularization
AI-Screening
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Trial Site Locations
Total: 1 location
1
Institut Català de la Salut (ICS)
Barcelona, Spain, 08007
Actively Recruiting
Research Team
R
Rafel Ramos Blanes, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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