NCT02450318

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2023

Completed
Last Updated

June 6, 2023

Status Verified

June 1, 2023

Enrollment Period

7.9 years

First QC Date

May 18, 2015

Last Update Submit

June 5, 2023

Conditions

Nonobstructive Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change in endothelium-independent dilation

    Baseline, 15 minutes after exercise

  • Change in arterial stiffness and wave reflection

    Baseline, 15 minutes after exercise and 1 hour after exercise

Study Arms (1)

Slow-paced walking

EXPERIMENTAL

Subjects will complete 47 minutes of walking at slow pace.

Other: Slow-paced walking

Interventions

Slow-paced walkingOTHER

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

Slow-paced walking

Eligibility Criteria

Age18 Years - 89 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integrative Cardiovasculal Physiology Laboratory

Gainesville, Florida, 32611, United States

Location

Study Officials

  • Demetra Christou, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2015

First Posted

May 21, 2015

Study Start

June 1, 2015

Primary Completion

April 14, 2023

Study Completion

April 14, 2023

Last Updated

June 6, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)