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

Completed

• Conditions: Carotid Plaque; Atheroscleroses, Cerebral

• Registration Number: NCT06187532
• Lead Sponsor: Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura

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).

Study Timeline

• Study Start: 2000-02-02
• Primary Completion: 2023-04-03
• Status Verified: 2023-12
• Study Completion: 2023-12-07
• Study First Submitted: 2023-12-14
• Study First Submitted QC: 2023-12-28
• Study First Posted: 2024-01-02
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1004

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in rates of all-cause death	12 year follow-up	All-cause death: number of death from any cause
Differences in rates of major adverse cardiovascular events (MACE)	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 Outcome Measures

Name	Time	Method
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	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.