AzTrials
AzTrials

Atheroscleroses, CerebralNCT06187532

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

An observational study of Atheroscleroses, Cerebral and Carotid Plaque, run by Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Atheroscleroses, Cerebral, Carotid Plaque
How many people
1,004 participants
Where
No sites listed yet
Study dates
2 Feb 2000to 7 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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

About this study

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

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).

Read the 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).

Keywords
carotid ultrasound., Carotid plaque-burden, atheroscleroses events prediction
Medical subject headings
Intracranial Arteriosclerosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 year follow-up

  2. Differences in rates of all-cause death

    All-cause death: number of death from any cause

    Measured: 12 year follow-up

Secondary outcomes (1)

  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

    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.

    Measured: 12 year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2024
  2. Study start2 Feb 2000
  3. Primary completion3 Apr 2023
  4. Study completion7 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,004 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06187532
Sponsor's protocol ID
1122023
Other IDs
11223
Status last verified
Dec 2023
First submitted
14 Dec 2023
Last updated
12 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sanchez-Bacaicoa C, Rico-Martin S, Costo-Muriel C, Ortega-Collazos E, Sanchez-Lozano M, Sanchez-Bacaicoa M, Galan-Gonzalez J, Calderon-Garcia JF, Munoz-Torrero JFS. Carotid Plaque-Burden scale and outcomes: A real-life study. Med Clin (Barc). 2025 Apr 11;164(7):325-333. doi: 10.1016/j.medcli.2024.10.009. Epub 2024 Nov 30. English, Spanish.

    PubMed 39617687

Questions about this trial

What is this clinical trial studying?

An observational study of Atheroscleroses, Cerebral and Carotid Plaque, run by Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences in rates of major adverse cardiovascular events (MACE) (time frame: 12 year follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06187532, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in