New Cardiovascular Risk Screening Strategy.

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.

Conditions

• Cardiovascular Prevention
• Screening
• Peripheral Artery Disease
• Arteriosclerosis
• Asymptomatic

Interventions

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.

Sponsors & Collaborators

• Hospital del Mar Research Institute (IMIM)

  collaborator OTHER

• Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

  collaborator OTHER

• Institut Català de la Salut

  collaborator OTHER

• Biocruces Bizkaia Health Research Institute

  collaborator OTHER_GOV

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

  lead OTHER

Principal Investigators

• Rafel Ramos Blanes, MD, PhD · Unidad de Investigación en Atención Primaria de Girona, IDIAP Jordi Gol

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

74 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-20

Primary Completion

2026-06-30

Completion

2026-06-30

Countries

• Spain

Study Locations