Clinical trial NCT06848283: Randomized Controlled Trial on Carotid Atherosclerosis Screening in Asymptomatic Smokers and Hypertensive Adults: Prevalence and Impact on Cardiovascular Prevention
Official title: Carotid Atherosclerosis Screening: Epidemiological Profile and Preventive Intervention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Carotid Artery Atheroma
Cardiovascular Risk Stratification
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 4780
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


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.

Primary outcomes:
measure: To characterize and identify the prevalence of carotid atherosclerosis
timeFrame: From the beginning of the study until 2 years, with possible reassessments at intervals up to a maximum of 10 years.
Secondary outcomes:
measure: Describe the prevalence by severity of carotid atherosclerosis and relate it to vascular risk factors
timeFrame: From the beginning of the study until the reassessment after one year, with possible reassessments at intervals up to a maximum of 10 years.
measure: To evaluate the impact of carotid ultrasonography on cardiovascular risk
timeFrame: From the beginning of the study until the reassessment after one year, with possible reassessments at intervals up to a maximum of 10 years.
measure: To assess the impact of carotid ultrasonography screening and the subsequent modifications in preventive measures on vascular events and mortality.
timeFrame: From the beginning of the study until the reassessment after one year, with possible reassessments at intervals up to a maximum of 10 years.
Other outcomes:
Locations:
Study officials:
References: