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

Carotid Plaque Clinical Trial

Official title:

Carotid Plaque-Burden Scale and Outcomes. Improvements in Risk Stratification for Future Cardiovascular Disease by Adding to SCORE2. A Real Life Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06187532
• Other study ID #: 1122023
• Secondary ID: 11223
• Status: Completed
• Start date: February 2, 2000
• Est. completion date: December 7, 2023

Study information

• Verified date: December 2023
• Source: Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1004
• Est. completion date: December 7, 2023
• Est. primary completion date: April 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atheroscleroses, Cerebral
• Atherosclerosis
• Carotid Plaque
• Intracranial Arteriosclerosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 year follow-up
Primary	Differences in rates of all-cause death	All-cause death: number of death from any cause	12 year follow-up
Secondary	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.	12 year follow-up