Subclinical Carotid AtherosclerosisAtheroDetectNCT02726321
Autonomic Testing in Subclinical Carotid Atherosclerosis
An observational study of Subclinical Carotid Atherosclerosis, run by Universidade Camilo Castelo Branco.
Trial summary
Background: Atherosclerotic carotid intima-media thickness (IMT) may be associated with alterations in the sensitivity of carotid and subclavian baroreceptors. Aim: The aim of this study is to investigate if carotid IMT is associated with changes in the autonomic modulation of the heart rate variability (HRV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subclinical Carotid Atherosclerosis
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Mar 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects referred to the Heart Institute of Santa Casa Charity (IACOR), Fernandopolis, Brazil for noninvasive carotid artery duplex ultrasonography. Carotid arteriosclerotic disease is evaluated through measuring the IMT and calculating the plaque score.
Who may be able to join
- Asymptomatic patients aged 18 years and older without a history of transient ischemic attack, stroke, or other neurologic signs or symptoms are selected to participate in the study.
Who cannot join
- Patients with symptomatic carotid artery stenosis were excluded if the patient had transient or permanent focal neurologic symptoms related to the ipsilateral retina or the cerebral hemisphere.
- Patients with heart rhythm disorders, pacemaker, heart failure, ejection fraction less than 0.45, chronic renal failure on hemodialysis, severe liver failure, myocardial infarction, endarterectomy, carotid angioplasty, carotid dissection and carotid occlusion were excluded.
- Patients receiving drugs known to interfere with autonomic function, such as beta-blockers, calcium channel blockers, angiotensin-converting enzyme inhibitors, vasodilators, statins, neuroleptics and nasal vasoconstrictors, were discontinued for 24 hours before the tests.
About this study
Official title: Early Detection of Subclinical Carotid Atherosclerosis Through Autonomic Testing
Background: Atherosclerotic carotid intima-media thickness (IMT) may be associated with alterations in the sensitivity of carotid and subclavian baroreceptors.
Aim: The aim of this study is to investigate if carotid IMT is associated with changes in the autonomic modulation of the heart rate variability (HRV).
Methods: This is a prospective cross-sectional study. The carotid IMT is determined by B-mode and duplex ultrasonography. The cardiovagal function was determined through linear and nonlinear measures of HRV. Linear regression models, adjusted for demographics, comorbidities, body mass index, waist-hip-ratio, and left ventricular ejection fraction will be used to evaluate the association between HRV parameters and carotid IMT.
- Conditions
- Subclinical Carotid Atherosclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
carotid intima-media thickness (IMT)
carotid IMT is determined by B-mode and duplex ultrasonography
Measured: 1 day
cardiovagal function
the cardiovagal function is determined through linear and nonlinear measures of HRV
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startSep 2014
- Primary completionJan 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subclinical Carotid AtherosclerosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Camilo Castelo Branco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ovidiu Constantin Baltatu, Universidade Camilo Castelo Branco
- Investigators
- Ovidiu C Baltatu, MD PhD, Study chair, Universidade Camilo Castelo BrancoValter L Pereira Jr., MD, Study director, Heart Institute of Santa Casa Charity (IACOR) Fernandopolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726321
- Sponsor's protocol ID
- BR-003-SJC
- Acronym
- AtheroDetect
- Status last verified
- Mar 2016
- First submitted
- 29 Mar 2016
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Subclinical Carotid Atherosclerosis Through Autonomic Testing
- ClinicalTrials.gov ID
- NCT02726321
- Acronym / sponsor ID
- AtheroDetect / BR-003-SJC
- Conditions
- Subclinical Carotid Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Universidade Camilo Castelo BrancoUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 1 Apr 2016 (estimated)
- 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.
Background: Atherosclerotic carotid intima-media thickness (IMT) may be associated with alterations in the sensitivity of carotid and subclavian baroreceptors.
Aim: The aim of this study is to investigate if carotid IMT is associated with changes in the autonomic modulation of the heart rate variability (HRV).
Methods: This is a prospective cross-sectional study. The carotid IMT is determined by B-mode and duplex ultrasonography. The cardiovagal function was determined through linear and nonlinear measures of HRV. Linear regression models, adjusted for demographics, comorbidities, body mass index, waist-hip-ratio, and left ventricular ejection fraction will be used to evaluate the association between HRV parameters and carotid IMT.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects referred to the Heart Institute of Santa Casa Charity (IACOR), Fernandopolis, Brazil for noninvasive carotid artery duplex ultrasonography. Carotid arteriosclerotic disease is evaluated through measuring the IMT and calculating the plaque score.
Key inclusion criteria (1 listed)
- Asymptomatic patients aged 18 years and older without a history of transient ischemic attack, stroke, or other neurologic signs or symptoms are selected to participate in the study.
Key exclusion criteria (3 listed)
- Patients with symptomatic carotid artery stenosis were excluded if the patient had transient or permanent focal neurologic symptoms related to the ipsilateral retina or the cerebral hemisphere.
- Patients with heart rhythm disorders, pacemaker, heart failure, ejection fraction less than 0.45, chronic renal failure on hemodialysis, severe liver failure, myocardial infarction, endarterectomy, carotid angioplasty, carotid dissection and carotid occlusion were excluded.
- Patients receiving drugs known to interfere with autonomic function, such as beta-blockers, calcium channel blockers, angiotensin-converting enzyme inhibitors, vasodilators, statins, neuroleptics and nasal vasoconstrictors, were discontinued for 24 hours before the tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
carotid intima-media thickness (IMT)
Time frame: 1 day
carotid IMT is determined by B-mode and duplex ultrasonography
cardiovagal function
Time frame: 1 day
the cardiovagal function is determined through linear and nonlinear measures of HRV
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ovidiu C Baltatu, MD PhD study chair
Universidade Camilo Castelo Branco
Valter L Pereira Jr., MD study director
Heart Institute of Santa Casa Charity (IACOR) Fernandopolis
Questions about this trial
What is this clinical trial studying?
An observational study of Subclinical Carotid Atherosclerosis, run by Universidade Camilo Castelo Branco.
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 1 inclusion and 3 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 24 Jan 2018. 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?
carotid intima-media thickness (IMT) (time frame: 1 day). 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?
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 24 Jan 2018.