跳至主要内容
临床试验/NCT05884840
NCT05884840招募中不适用

Health Program for prEvention of cardiovascuLar disEases Based on a Risk screeNing Strategy With Ankle-brachial Index.

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina2 个研究点 分布在 1 个国家目标入组 54,000 人开始时间: 2023年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
54,000
试验地点
2
主要终点
Proteinuria (CVD risk factors improvement assessment)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
50 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Symptomatic PAD
  • Coronary disease
  • Cardiac revascularization

结局指标

主要结局

Proteinuria (CVD risk factors improvement assessment)

时间窗: 3 years

mg/dL protein in urine

Lipid profile (CVD risk factors improvement assessment)

时间窗: 3 years

Total cholesterol (mg/dl), LDL (mg/dl), HDL (mg/dl), Triglycerides (mg/dl)

Systolic and diastolic pressure (CVD risk factors improvement assessment)

时间窗: 3 years

mm Hg

Weight (CVD risk factors improvement assessment)

时间窗: 3 years

kg

Height (CVD risk factors improvement assessment)

时间窗: 3 years

m

Hard coronary heart disease (CHD)

时间窗: 3 years

Myocardial infarction, cardiac revascularization, or coronary death

Major adverse cardiovascular event (MACE)

时间窗: 3 years

A composite of hard CHD (myocardial infarction, cardiac revascularization, or coronary death) and stroke (fatal and nonfatal ischemic stroke)

All-cause mortality

时间窗: 3 years

Tabaco consumption (CVD risk factors improvement assessment)

时间窗: 3 years

Smoker, ex-smoker or non-smoker

BMI (CVD risk factors improvement assessment)

时间窗: 3 years

(kg/m2) Will be calculated dividing the weight in kilograms by their height in metres squared

Glycaemia (CVD risk factors improvement assessment)

时间窗: 3 years

Fasting blood sugar (mg/dl)

Albumin-to-creatinine ratio (ACR) (CVD risk factors improvement assessment)

时间窗: 3 years

ACR (mg/g) will be calculated by by dividing mg of proteinuria (albumine) by g of creatinine.

Glomerular filtrate rate (CVD risk factors improvement assessment)

时间窗: 3 years

Levels of creatinine in milliliters of cleansed blood per minute per body surface (mL/min/1.73m2).

Glycated haemoglobin (CVD risk factors improvement assessment)

时间窗: 3 years

(in DM patients) glycosylated hemoglobin in the blood (mg/dl) or percentage (%)

Creatinine (CVD risk factors improvement assessment)

时间窗: 3 years

mg/dL

次要结局

  • Lipid lowering medication Adverse effects(3 years)
  • Coronary heart disease(3 years)
  • Cerebrovascular disease(3 years)
  • Cardiovascular disease(3 years)

研究者

发起方
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验