Acute Vascular Response to Exercise in Women With Nonobstructive Coronary Artery Disease

Sponsor

University of Florida (Other)

Overall Status

Recruiting

CT.gov ID

NCT02450318

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to examine the acute effect of exercise on vascular function in women with nonobstructive coronary artery disease.

Condition or Disease	Intervention/Treatment	Phase
Nonobstructive Coronary Artery Disease	Other: Slow-paced walking	N/A

Detailed Description

Women are more likely to have nonobstructive coronary artery disease (CAD) . The purpose of this study is to examine the acute effect of exercise on vascular function in women with nonobstructive coronary artery disease. Endothelium-dependent and -independent dilation, arterial stiffness and wave reflection will be measured at baseline and after walking on a treadmill at a slow pace for 47 minutes. Endothelium-dependent dilation will be measured using brachial artery flow-mediated dilation via high resolution ultrasonography. Endothelium-independent dilation will be measured using brachial artery dilation to sublingual nitroglycerin. Arterial stiffness and wave reflection will measured using applanation tonometry.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Acute Vascular Response to Exercise in Women With Nonobstructive Coronary Artery Disease

Actual Study Start Date :

Jun 1, 2015

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Slow-paced walking Subjects will complete 47 minutes of walking at slow pace.	Other: Slow-paced walking Subjects will walk on a treadmill at a slow pace for 47 minutes

Arm

Intervention/Treatment

Experimental: Slow-paced walking

Subjects will complete 47 minutes of walking at slow pace.

Other: Slow-paced walking

Subjects will walk on a treadmill at a slow pace for 47 minutes

Outcome Measures

Primary Outcome Measures

Change in endothelium-dependent dilation [Baseline, 15 minutes after exercise and 1 hour after exercise]
Brachial artery endothelium-dependent flow-mediated dilation to reactive hyperemia will be measured using high resolution ultrasonography. To determine flow-mediated dilation, brachial artery diameter and blood velocity will be measured before and after occluding the forearm for 5 minutes by inflating a cuff to 250 mmHg.

Secondary Outcome Measures

Change in endothelium-independent dilation [Baseline, 15 minutes after exercise]
To determine vascular smooth muscle responsiveness to nitric oxide, brachial artery diameter will be measured using high resolution ultrasonography before and after sublingual administration of 0.4mg nitroglycerin.
Change in arterial stiffness and wave reflection [Baseline, 15 minutes after exercise and 1 hour after exercise]
Aortic pulse wave velocity and augmentation index will be measured using applanation tonometry.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

women with non-obstructive coronary artery disease documented within the past 5 years by coronary angiogram as no coronary arteries with stenosis greater than 50% lesions
age 18 to 89 years
able to complete maximal graded exercise test

Exclusion Criteria:

use of tobacco products within the previous six months
use of oral contraceptives or hormone replacement therapy within the prior year
pregnancy (positive urine pregnancy test) or lactation
history of hepatic disease or infection with hepatitis B, C or HIV

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Integrative Cardiovasculal Physiology Laboratory	Gainesville	Florida	United States	32611

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator: Demetra Christou, PhD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Florida

ClinicalTrials.gov Identifier:

NCT02450318

Other Study ID Numbers:

IRB201500077

First Posted:

May 21, 2015

Last Update Posted:

Jun 30, 2022

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Coronary Artery Disease

Myocardial Ischemia

Coronary Disease

Study Results

No Results Posted as of Jun 30, 2022