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

NCT ID: NCT06187532

Last Updated: 2024-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1004 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-02-02

Study Completion Date

2023-12-07

Brief Summary

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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

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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).

Conditions

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Atheroscleroses, Cerebral Carotid Plaque

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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JUAN SANCHEZ M-TORRERO, PhD

Role: STUDY_CHAIR

Universidad Extremadura

Other Identifiers

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11223

Identifier Type: OTHER

Identifier Source: secondary_id

1122023

Identifier Type: -

Identifier Source: org_study_id

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