Autonomic Testing in Subclinical Carotid Atherosclerosis

NCT02726321 | Completed

• 1 other identifier: BR-003-SJC
• Study Type: observational
• Target: 101
• Locations: 0 countries
• Sites: N/A

Brief 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). 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

Outcome Measures

Primary Outcomes (2)

• carotid intima-media thickness (IMT)

  carotid IMT is determined by B-mode and duplex ultrasonography

  1 day

• cardiovagal function

  the cardiovagal function is determined through linear and nonlinear measures of HRV

  1 day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Camilo Castelo Branco: lead

Study Officials

• Ovidiu C Baltatu, MD PhD

  Universidade Camilo Castelo Branco

  STUDY CHAIR

• Valter L Pereira Jr., MD

  Heart Institute of Santa Casa Charity (IACOR) Fernandopolis

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 1, 2016
• Study Start: September 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: January 24, 2018

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share