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

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

Study Overview

• Status: Completed
• Conditions: Nonobstructive Coronary Artery Disease
• Intervention / Treatment: Other: Slow-paced walking

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • Integrative Cardiovasculal Physiology Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Demetra Christou, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): April 14, 2023
• Study Completion (Actual): April 14, 2023

Study Registration Dates

• First Submitted: May 18, 2015
• First Submitted That Met QC Criteria: May 18, 2015
• First Posted (Estimated): May 21, 2015

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: IRB201500077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No