Carotid Plaque-Burden Scale and Outcomes. Improvements in Risk Stratification for Future Cardiovascular Disease by Adding to SCORE2. A Real Life Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,004
- 主要终点
- Differences in rates of all-cause death
研究概览
简要总结
Carotid ultrasonography has been proposed as a tool for prediction of future cardiovascular disease (CVD). Nevertheless, its role in clinical practice remains controversial.
Methods: The investigators analyse the incidence of CVD and mortality in a cohort of 1004 participants without preexisting CVD according to a simple plaque scale recorded in different segments of the carotid artery assess by ultrasound. A prognostic tool for CV events was development adding Carotid Plaque-Burden (CPB) scale to the Systematic COronary Risk Evaluation (SCORE2) table (CPB- SCORE2 scale).
详细描述
Based in number of plaques and stenosis a simple plaque scale was recorded in different segments of carotid artery, involving a cohort of 1004 participants with vascular risk factors. Outcomes were recorded during 14 years. A prognostic tool for CV events was development adding simple Carotid Plaque-Burden (CPB) scale to the SCORE2 table (CPB- SCORE2 scale).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any of these vascular risk factors: Total cholesterol >200 mg/dL, hypertension, or diabetes, or receiving medication for them
- •No cardiovascular disease: coronary, cerebral o peripheral arterial disease.
排除标准
- •Associated conditions: cancer, heart failure, chronic obstructive disease, renal insufficiency, neurodegenerative diseases, rheumatic diseases or chronic infections.
- •Neck anatomical barriers to perform ultrasound.
- •Enrolled in a clinical trial.
- •Attend <70% of regular appointments
结局指标
主要结局
Differences in rates of all-cause death
时间窗: 12 year follow-up
All-cause death: number of death from any cause
Differences in rates of major adverse cardiovascular events (MACE)
时间窗: 12 year follow-up
MACE: number of Major Adverse Cardiovascular Events; myocardial infarction, ictus or amputation or revascularisation of leg due to critical ischaemia
次要结局
- Diagnostic value of Carotid Plaque-Burden-Systematic COronary Risk EvaluationSystematic COronary Risk Evaluation2 (CPB-SCORE2) table compared to Systematic COronary Risk Evaluation2 (SCORE2) for MACE(12 year follow-up)