Carotid Artery AtheromaCAROTID-CARENCT06848283
Randomized Controlled Trial on Carotid Atherosclerosis Screening in Asymptomatic Smokers and Hypertensive Adults: Prevalence and Impact on Cardiovascular Prevention
A study testing Carotid ultrasonography in people with Carotid Artery Atheroma and Cardiovascular Risk Stratification, run by Universidade do Porto.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Carotid Artery Atheroma, Cardiovascular Risk Stratification
- What is being tested?
- Carotid ultrasonography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,780 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged ≥40 years and <70 years, hypertensive and smokers
- Registered in ACeS Maia/Valongo
- Willing to participate in the study
Who cannot join
- Inability to provide consent.
- Patients with a previous stroke, symptomatic coronary artery disease, or symptomatic peripheral artery disease will be excluded.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
- Being tested
- Carotid ultrasonography
- Medical subject headings
- Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid ultrasonographyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients included in the intervention group will undergo a carotid ultrasonography (a non-invasive imaging exam) for the early detection of atherosclerotic plaques. Receives: Diagnostic Test: Carotid ultrasonography |
| Control Group | No intervention | Control group (does not undergo carotid ultrasonography). |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize and identify the prevalence of carotid atherosclerosis
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.
Measured: From the beginning of the study until 2 years, with possible reassessments at intervals up to a maximum of 10 years.
Secondary outcomes (3)
Describe the prevalence by severity of carotid atherosclerosis and relate it to vascular risk factors
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.
Measured: 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
To evaluate the impact of carotid ultrasonography on cardiovascular risk calculation and, consequently, on risk-adjusted preventive measures.
Measured: 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.
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.
Measured: From the beginning of the study until the reassessment after one year, with possible reassessments at intervals up to a maximum of 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery AtheromaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,780 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848283
- Sponsor's protocol ID
- CarotidAtheroScreening
- Acronym
- CAROTID-CARE
- Status last verified
- Dec 2024
- First submitted
- 12 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Atherosclerosis Screening: Epidemiological Profile and Preventive Intervention
- ClinicalTrials.gov ID
- NCT06848283
- Acronym / sponsor ID
- CAROTID-CARE / CarotidAtheroScreening
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,780 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Diagnostic Test: Carotid ultrasonographyPatients included in the intervention group will undergo a carotid ultrasonography (a non-invasive imaging exam) for the early detection of atherosclerotic plaques. |
| Control Group | No intervention | –Control group (does not undergo carotid ultrasonography). |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged ≥40 years and <70 years, hypertensive and smokers
- Registered in ACeS Maia/Valongo
- Willing to participate in the study
Key exclusion criteria (2 listed)
- Inability to provide consent.
- Patients with a previous stroke, symptomatic coronary artery disease, or symptomatic peripheral artery disease will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carotid ultrasonographyAll 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. | Diagnostic test | Intervention group |
Primary outcome
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.
3 secondary outcomes
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 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 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Carotid ultrasonography in people with Carotid Artery Atheroma and Cardiovascular Risk Stratification, run by Universidade do Porto.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 27 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Duarte Pinto, MD ((+351) 225 513 600, up200600092@med.up.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2025.