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

NCT06187532 | Completed

• 2 other identifiers: 112202311223
• Study Type: observational
• Target: 1,004
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Atheroscleroses, Cerebral; Carotid Plaque

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• Differences in rates of all-cause death

  All-cause death: number of death from any cause

  12 year follow-up

Secondary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a major vascular risk factor, hypertension, diabetes or hypercholesterolemia, from vascular risk office at the Hospital Universitario San Pedro de Alcántara, Cáceres, Spain

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura: lead

MeSH Terms

Conditions

Intracranial Arteriosclerosis

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• JUAN SANCHEZ M-TORRERO, PhD

  Universidad Extremadura

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: January 2, 2024
• Study Start: February 2, 2000
• Primary Completion: April 3, 2023
• Study Completion: December 7, 2023
• Last Updated: February 12, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share