Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02450318
Recruitment Status : Recruiting
First Posted : May 21, 2015
Last Update Posted : August 13, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Nonobstructive Coronary Artery Disease Other: Slow-paced walking Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2015
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in endothelium-dependent dilation [ Time Frame: 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 :
  1. Change in endothelium-independent dilation [ Time Frame: 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.

  2. Change in arterial stiffness and wave reflection [ Time Frame: Baseline, 15 minutes after exercise and 1 hour after exercise ]
    Aortic pulse wave velocity and augmentation index will be measured using applanation tonometry.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02450318


Contacts
Layout table for location contacts
Contact: Demetra Christou, PhD 352-294-1746 ICPL@hhp.ufl.edu
Contact: Eileen Handberg 352-273-9082 handbem@medicine.ufl.edu

Locations
Layout table for location information
United States, Florida
Integrative Cardiovasculal Physiology Laboratory Recruiting
Gainesville, Florida, United States, 32611
Contact: Demetra Christou, PhD    352-294-1746    ICPL@hhp.ufl.edu   
Sponsors and Collaborators
University of Florida
Investigators
Layout table for investigator information
Principal Investigator: Demetra Christou, PhD University of Florida
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02450318    
Other Study ID Numbers: IRB201500077
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: August 13, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases