Carotid Plaque-Burden Scale and Outcomes. Improvements in Risk Stratification for Future Cardiovascular Disease by Adding to SCORE2. A Real Life Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atheroscleroses, Cerebral
- Sponsor
- Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura
- Enrollment
- 1004
- Primary Endpoint
- Differences in rates of all-cause death
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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).
Detailed Description
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Differences in rates of all-cause death
Time Frame: 12 year follow-up
All-cause death: number of death from any cause
Differences in rates of major adverse cardiovascular events (MACE)
Time Frame: 12 year follow-up
MACE: number of Major Adverse Cardiovascular Events; myocardial infarction, ictus or amputation or revascularisation of leg due to critical ischaemia
Secondary Outcomes
- 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)