Autonomic Testing in Subclinical Carotid Atherosclerosis

Subclinical Carotid Atherosclerosis Clinical Trial

— AtheroDetect  

Official title:

Early Detection of Subclinical Carotid Atherosclerosis Through Autonomic Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02726321
• Other study ID #: BR-003-SJC
• Status: Completed
• Phase: N/A
• First received: March 29, 2016
• Last updated: January 23, 2018
• Start date: September 2014
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Universidade Camilo Castelo Branco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Diseases
• Subclinical Carotid Atherosclerosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Camilo Castelo Branco

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	carotid intima-media thickness (IMT)	carotid IMT is determined by B-mode and duplex ultrasonography	1 day
Primary	cardiovagal function	the cardiovagal function is determined through linear and nonlinear measures of HRV	1 day