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

Nonobstructive Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02450318
• Other study ID #: IRB201500077
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: April 14, 2023

Study information

• Verified date: June 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: April 14, 2023
• Est. primary completion date: April 14, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Nonobstructive Coronary Artery Disease

Intervention

Other:
• Slow-paced walking
Subjects will walk on a treadmill at a slow pace for 47 minutes

Locations

Country	Name	City	State
United States	Integrative Cardiovasculal Physiology Laboratory	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in endothelium-dependent dilation	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.	Baseline, 15 minutes after exercise and 1 hour after exercise
Secondary	Change in endothelium-independent dilation	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.	Baseline, 15 minutes after exercise
Secondary	Change in arterial stiffness and wave reflection	Aortic pulse wave velocity and augmentation index will be measured using applanation tonometry.	Baseline, 15 minutes after exercise and 1 hour after exercise