Acute Vascular Response to Exercise in Women With Nonobstructive Coronary Artery Disease
Primary Purpose
Nonobstructive Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Slow-paced walking
Sponsored by
About this trial
This is an interventional other trial for Nonobstructive Coronary Artery Disease
Eligibility Criteria
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
Sites / Locations
- Integrative Cardiovasculal Physiology Laboratory
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Slow-paced walking
Arm Description
Subjects will complete 47 minutes of walking at slow pace.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Change in arterial stiffness and wave reflection
Aortic pulse wave velocity and augmentation index will be measured using applanation tonometry.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02450318
Brief Title
Acute Vascular Response to Exercise in Women With Nonobstructive Coronary Artery Disease
Official Title
Acute Vascular Response to Exercise in Women With Nonobstructive Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
April 14, 2023 (Actual)
Study Completion Date
April 14, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonobstructive Coronary Artery Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Slow-paced walking
Arm Type
Experimental
Arm Description
Subjects will complete 47 minutes of walking at slow pace.
Intervention Type
Other
Intervention Name(s)
Slow-paced walking
Intervention Description
Subjects will walk on a treadmill at a slow pace for 47 minutes
Primary Outcome Measure Information:
Title
Change in endothelium-dependent dilation
Description
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.
Time Frame
Baseline, 15 minutes after exercise and 1 hour after exercise
Secondary Outcome Measure Information:
Title
Change in endothelium-independent dilation
Description
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.
Time Frame
Baseline, 15 minutes after exercise
Title
Change in arterial stiffness and wave reflection
Description
Aortic pulse wave velocity and augmentation index will be measured using applanation tonometry.
Time Frame
Baseline, 15 minutes after exercise and 1 hour after exercise
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Demetra Christou, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Integrative Cardiovasculal Physiology Laboratory
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Acute Vascular Response to Exercise in Women With Nonobstructive Coronary Artery Disease
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