Randomized Controlled Trial on Carotid Atherosclerosis Screening in Asymptomatic Smokers and Hypertensive Adults: Prevalence and Impact on Cardiovascular Prevention (CAROTID-CARE)

February 21, 2025 updated by: Universidade do Porto

Carotid Atherosclerosis Screening: Epidemiological Profile and Preventive Intervention

Title of the study: Carotid Atherosclerosis Screening: Epidemiological Profile and Preventive Intervention.

Objective: The main objective of this study is to characterize and identify the prevalence of carotid atherosclerosis in adults who are still asymptomatic for vascular disease and to evaluate the impact of detecting carotid atherosclerosis on preventive strategies. The study covers a population of approximately 4,780 patients.

Estimated Duration of the Project: The estimated duration of the project is 36 months, starting in February 2025, with the possibility of an extension if necessary.

Entities that approved the study: This study has been reviewed and approved by the Executive Director and President of the Clinical and Health Council of ACeS Grande Porto III - Maia/Valongo, as well as the Health Ethics Committee of the Northern Regional Health Administration (ARS Norte). The Addendum has also been approved by the Ethics Committee of the São João Local Health Unit (ULS São João).

Explanation of the Study:

This study will take place at ULS São João, including the São João University Hospital Center and the Primary Care Grouping (ACeS) Grande Porto III - Maia/Valongo.

The study includes two groups. Patients in the intervention group will undergo a neck ultrasound (a non-invasive imaging exam) for the early detection of atherosclerotic plaques. Demographic data (sex, age, educational level, employment status), vascular risk factors (smoking, alcohol consumption, blood pressure, and lipid profile), and anthropometric data (waist circumference and BMI) will be documented and analyzed by the research team. Medication, previous treatments, and other preventive initiatives will also be recorded. Glycemic and lipid profiles of participants will be collected.

Based on the results, the individual cardiovascular risk will be calculated using the SCORE2 global cardiovascular risk assessment chart from the European Society of Cardiology, both before and after incorporating ultrasound findings. Subsequently, personalized recommendations for preventive and therapeutic strategies will be developed for each patient and shared with family physicians.

To identify potential vascular risk biomarkers, venous blood samples will be collected in the intervention group. Patients identified with high-risk atherosclerotic plaques will be referred for further evaluation at the Neurology/Cerebrovascular Disease outpatient clinic of the São João University Hospital Center, ULS São João.

Patients in the other group (control group) will follow the same protocol, except for the neck ultrasound. To identify potential vascular risk biomarkers, venous blood collection will be performed in the intervention group during the carotid ultrasound (Doppler ultrasound). Both groups will be reassessed at a later stage. If a participant meets the exclusion criteria for the study, this will be duly explained to them.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

4780

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults aged ≥40 years and <70 years, hypertensive and smokers
  • Registered in ACeS Maia/Valongo
  • Willing to participate in the study

Exclusion Criteria:

  • Inability to provide consent.
  • Patients with a previous stroke, symptomatic coronary artery disease, or symptomatic peripheral artery disease will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Patients included in the intervention group will undergo a carotid ultrasonography (a non-invasive imaging exam) for the early detection of atherosclerotic plaques.
Diagnostic test: Carotid ultrasonography
All examinations will be performed by a technician specialized in neurosonology, using the same technical protocol. For this purpose, a portable ultrasound device with a linear probe (L3-9 MHz) will be used. A quick screening will be conducted to check for the presence of atherosclerosis.
No Intervention: Control Group
Control group (does not undergo carotid ultrasonography).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To characterize and identify the prevalence of carotid atherosclerosis
Time Frame: From the beginning of the study until 2 years, with possible reassessments at intervals up to a maximum of 10 years.
The main objective of this study is to characterize and identify the prevalence of carotid atherosclerosis in adults, smokers, and hypertensive individuals who are still asymptomatic for arterial vascular disease, and to evaluate the impact of having carotid atherosclerosis on preventive strategies.
From the beginning of the study until 2 years, with possible reassessments at intervals up to a maximum of 10 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe the prevalence by severity of carotid atherosclerosis and relate it to vascular risk factors
Time Frame: From the beginning of the study until the reassessment after one year, with possible reassessments at intervals up to a maximum of 10 years.
To describe the prevalence by severity of carotid atherosclerosis and relate it to sex, age, other known vascular risk factors (smoking, hypertension, diabetes, dyslipidemia, physical inactivity, alcohol consumption, overweight/obesity), and serum biomarkers; assess the potential protective effect of previous preventive treatments.
From the beginning of the study until the reassessment after one year, with possible reassessments at intervals up to a maximum of 10 years.
To evaluate the impact of carotid ultrasonography on cardiovascular risk
Time Frame: From the beginning of the study until the reassessment after one year, with possible reassessments at intervals up to a maximum of 10 years.
To evaluate the impact of carotid ultrasonography on cardiovascular risk calculation and, consequently, on risk-adjusted preventive measures.
From the beginning of the study until the reassessment after one year, with possible reassessments at intervals up to a maximum of 10 years.
To assess the impact of carotid ultrasonography screening and the subsequent modifications in preventive measures on vascular events and mortality.
Time Frame: From the beginning of the study until the reassessment after one year, with possible reassessments at intervals up to a maximum of 10 years.
The effects of preventive measures on the occurrence of vascular events (such as stroke and myocardial infarction), morbidity, and mortality rates will be reassessed one year after the initial evaluation.
From the beginning of the study until the reassessment after one year, with possible reassessments at intervals up to a maximum of 10 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade do Porto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

February 12, 2025

First Submitted That Met QC Criteria

February 21, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CarotidAtheroScreening

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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