Clinical trial NCT05884840: New Cardiovascular Risk Screening Strategy.
Official title: Health Program for prEvention of cardiovascuLar disEases Based on a Risk screeNing Strategy With Ankle-brachial Index.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Prevention
Screening
Peripheral Artery Disease
Arteriosclerosis
Asymptomatic
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Hospital del Mar Research Institute (IMIM)
name: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
name: Institut Català de la Salut
name: Biocruces Bizkaia Health Research Institute
First posted: 2023-06-01
Enrollment: 54000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be conducted as a clustered randomized pragmatic clinical trial (CRT) in primary care practice. During the period of two years (2023-2025), randomization of the eight Health Regions (274 primary care centres) in Catalonia will take place. The current strategy, in Catalonia, for cardiovascular risk screening is based on risk assessment using Framingham-REGICOR risk function. In the intervention group, a screening program with ABI will be added to all 50-74-year-old individuals with Framingham-REGICOR risk ≥7% and high probability of having ABI≤0.9. The probability of having ABI≤0.9 will be estimated using the REASON function and will be defined as a probability ≥7%. People that are classified as ABI≤0.9 high-risk, will undergo a PAD screening program using ABI test. If the result of the ABI is equal and lower than 0.9, indications of the Health Catalan Institute's CV and lipid guidelines will be recommended by physicians to the patients.
Primary purpose: PREVENTION

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

Primary outcomes:
measure: Hard coronary heart disease (CHD)
timeFrame: 3 years
measure: Major adverse cardiovascular event (MACE)
timeFrame: 3 years
measure: All-cause mortality
timeFrame: 3 years
measure: Tabaco consumption (CVD risk factors improvement assessment)
timeFrame: 3 years
measure: Lipid profile (CVD risk factors improvement assessment)
timeFrame: 3 years
measure: Systolic and diastolic pressure (CVD risk factors improvement assessment)
timeFrame: 3 years
measure: Weight (CVD risk factors improvement assessment)
timeFrame: 3 years
measure: Height (CVD risk factors improvement assessment)
timeFrame: 3 years
measure: BMI (CVD risk factors improvement assessment)
timeFrame: 3 years
measure: Glycaemia (CVD risk factors improvement assessment)
timeFrame: 3 years
measure: Glycated haemoglobin (CVD risk factors improvement assessment)
timeFrame: 3 years
measure: Creatinine (CVD risk factors improvement assessment)
timeFrame: 3 years
measure: Proteinuria (CVD risk factors improvement assessment)
timeFrame: 3 years
measure: Albumin-to-creatinine ratio (ACR) (CVD risk factors improvement assessment)
timeFrame: 3 years
measure: Glomerular filtrate rate (CVD risk factors improvement assessment)
timeFrame: 3 years
Secondary outcomes:
measure: Coronary heart disease
timeFrame: 3 years
measure: Cerebrovascular disease
timeFrame: 3 years
measure: Cardiovascular disease
timeFrame: 3 years
measure: Lipid lowering medication Adverse effects
timeFrame: 3 years
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Institut Català de la Salut (ICS)
Study officials:
affiliation: Unidad de Investigación en Atención Primaria de Girona, IDIAP Jordi Gol
name: Rafel Ramos Blanes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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