Actively Recruiting

Phase Not Applicable
Age: 50Years - 74Years
All Genders
NCT05884840

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

Age: 50Years - 74Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • Symptomatic peripheral artery disease
  • Coronary disease
  • Stroke
  • Previous cardiac revascularization

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Institut Català de la Salut (ICS)

Barcelona, Spain, 08007

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

New Cardiovascular Risk Screening Strategy. | DecenTrialz