Carotid Plaque-Burden Scale and Outcomes. A Real Life Study

Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura1,004 enrolled

Overview

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).

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).

Study Type

OBSERVATIONAL

Enrollment

1,004

Conditions

Atheroscleroses, Cerebral Carotid Plaque

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 major adverse cardiovascular events (MACE)

MACE: number of Major Adverse Cardiovascular Events; myocardial infarction, ictus or amputation or revascularisation of leg due to critical ischaemia

Time frame: 12 year follow-up

Differences in rates of all-cause death

All-cause death: number of death from any cause

Time frame: 12 year follow-up

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

Minimum and maximum values are 1 and 3, were higher scores mean a worse outcome. Sensitivity, Specificity, negative predictive value; positive likelihood ratio; negative likelihood ratio (%). net reclassification index;will be compared between High-Risk vs Low-Intermediate-Risk to PBS-SCORE2 table compared SCORE2.

Time frame: 12 year follow-up