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

Not Applicable

Completed

• Conditions: Nonobstructive Coronary Artery Disease
• Interventions: Other: Slow-paced walking

• Registration Number: NCT02450318
• Lead Sponsor: University of Florida

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.

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 Timeline

• Study First Submitted: 2015-05-18
• Study First Submitted QC: 2015-05-18
• Study First Posted: 2015-05-21
• Study Start: 2015-06
• Primary Completion: 2023-04-14
• Study Completion: 2023-04-14
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-05
• Last Update Posted: 2023-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Slow-paced walking	Slow-paced walking	Subjects will complete 47 minutes of walking at slow pace.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Integrative Cardiovasculal Physiology Laboratory; 🇺🇸 Gainesville, Florida, United States