Autonomic Testing in Subclinical Carotid Atherosclerosis

Early Detection of Subclinical Carotid Atherosclerosis Through Autonomic Testing

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02726321

Acronym

AtheroDetect

Enrollment

101

Registered

2016-04-01

Start date

2014-09-30

Completion date

2016-03-31

Last updated

2018-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subclinical Carotid Atherosclerosis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Outcome results