Nonobstructive Coronary Artery DiseaseNCT02450318
Acute Vascular Response to Exercise in Women With Nonobstructive Coronary Artery Disease
A study testing Slow-paced walking in people with Nonobstructive Coronary Artery Disease, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to examine the acute effect of exercise on vascular function in women with nonobstructive coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women only
- Conditions the study is for
- Nonobstructive Coronary Artery Disease
- What is being tested?
- Slow-paced walking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 14 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrative Cardiovasculal Physiology Laboratory
Gainesville, Florida, 32611
About this study
The purpose of this study is to examine the acute effect of exercise on vascular function in women with nonobstructive coronary artery disease.
Read the 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.
- Conditions
- Nonobstructive Coronary Artery Disease
- Being tested
- Slow-paced walking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow-paced walkingOther
Subjects will walk on a treadmill at a slow pace for 47 minutes
| Study group | Role | What they receive |
|---|---|---|
| Slow-paced walking | Experimental | Subjects will complete 47 minutes of walking at slow pace. Receives: Other: Slow-paced walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 15 minutes after exercise and 1 hour after exercise
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, 15 minutes after exercise and 1 hour after exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startJun 2015
- Primary completion14 Apr 2023
- Study completion14 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonobstructive Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Demetra Christou, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02450318
- Sponsor's protocol ID
- IRB201500077
- Status last verified
- Jun 2023
- First submitted
- 18 May 2015
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Vascular Response to Exercise in Women With Nonobstructive Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT02450318
- Acronym / sponsor ID
- IRB201500077
- Conditions
- Nonobstructive Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- 14 Apr 2023 (actual)
- Study completion
- 14 Apr 2023 (actual)
- First posted
- 21 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Slow-paced walking | Experimental | Other: Slow-paced walkingSubjects will complete 47 minutes of walking at slow pace. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Slow-paced walkingSubjects will walk on a treadmill at a slow pace for 47 minutes | Other | Slow-paced walking |
Primary outcome
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.
2 secondary outcomes
Change in endothelium-independent dilation
Time frame: Baseline, 15 minutes after exercise
Change in arterial stiffness and wave reflection
Time frame: Baseline, 15 minutes after exercise and 1 hour after exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Demetra Christou, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slow-paced walking in people with Nonobstructive Coronary Artery Disease, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in endothelium-dependent dilation (time frame: Baseline, 15 minutes after exercise and 1 hour after exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.