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Completed

NCT Number: NCT02450318

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.

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Key information

Age range

18 year–89 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Integrative Cardiovasculal Physiology Laboratory

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Slow-paced walking

Other

Subjects will walk on a treadmill at a slow pace for 47 minutes

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
May 21, 2015
Registry last updated
Jun 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.