Randomized Controlled Trial on Carotid Atherosclerosis Screening in Asymptomatic Smokers and Hypertensive Adults: Prevalence and Impact on Cardiovascular Prevention

NCT ID: NCT06848283

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 4780 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2028-02-29

Brief Summary

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.

Conditions

Carotid Artery Atheroma; Cardiovascular Risk Stratification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Carotid ultrasonography

Intervention Type: DIAGNOSTIC_TEST

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.

Control Group

Control group (does not undergo carotid ultrasonography).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade do Porto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Duarte Pinto, MD

Role: CONTACT

up200600092@med.up.pt

(+351) 225 513 600

Other Identifiers

CarotidAtheroScreening

Identifier Type: -

Identifier Source: org_study_id