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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06187532
Enrollment
1004
Registered
2024-01-02
Start date
2000-02-02
Completion date
2023-12-07
Last updated
2024-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atheroscleroses, Cerebral, Carotid Plaque

Keywords

carotid ultrasound., Carotid plaque-burden, atheroscleroses events prediction

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).

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Differences in rates of major adverse cardiovascular events (MACE)12 year follow-upMACE: number of Major Adverse Cardiovascular Events; myocardial infarction, ictus or amputation or revascularisation of leg due to critical ischaemia
Differences in rates of all-cause death12 year follow-upAll-cause death: number of death from any cause

Secondary

MeasureTime frameDescription
Diagnostic value of Carotid Plaque-Burden-Systematic COronary Risk EvaluationSystematic COronary Risk Evaluation2 (CPB-SCORE2) table compared to Systematic COronary Risk Evaluation2 (SCORE2) for MACE12 year follow-upMinimum 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026