Microvascular Coronary DysfunctionNCT02374086
Benefits of Exercise Training in Women With Ischemic Syndrome
A study testing Exercise training in people with Microvascular Coronary Dysfunction, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
Angina in the absence of obstructive coronary artery disease is highly prevalent in women, and leads to increased risk for major cardiovascular events, including myocardial infarction, stroke, and heart failure. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Microvascular Coronary Dysfunction
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Oct 2016
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with persistent chest pain but no obstructive disease (defined as 50% luminal diameter stenosis in >1 epicardial coronary arteries)
- Fully understanding and willing to undergo study procedures
- Understanding and willing to sign consent form.
Who cannot join
- Acute coronary syndrome (defined by WHO), cardiogenic shock or requiring inotropic or intra-aortic balloon support;
- Planned percutaneous coronary intervention or coronary artery bypass graft or established obstructive CAD with ischemia eligible for revascularization,
- Acute myocardial infarction;
- Patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support;
- Prior non-cardiac illness with an estimated life expectancy <4 years;
- Unable to give informed consent;
Show all 17Show fewer
- Allergy or contra-indication to cardiac magnetic resonance imaging, including renal failure, claustrophobia, and asthma, uncontrolled moderate hypertension (sitting blood pressure >160/95 mmHg with measurements recorded on at least 2 occasions), conditions likely to influence outcomes: Severe lung, creatinine >1.8 or CrCl ≤ 50ml/min) or hepatic disease;
- Contraindications to adenosine or regadensoson (Lexiscan)
- Surgically uncorrected significant congenital or valvular heart disease and other disease likely to be fatal or require frequent hospitalization within the next six months;
- Adherence or retention issues;
- Unwilling to complete follow-up evaluation;
- Aortic stenosis (valve area <1.5cm);
- Left ventricular systolic dysfunction (ejection fraction <35%);
- Taking potent CYP3A4 inhibitors (ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir);
- Women who are pregnant.
- Allergy to animal dander.
- Unable to perform exercise
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: A Pilot Study to Test the Benefits of Exercise Training in Women With Ischemic Syndrome
Angina in the absence of obstructive coronary artery disease is highly prevalent in women, and leads to increased risk for major cardiovascular events, including myocardial infarction, stroke, and heart failure. Annual mortality rates are ten-fold higher than mortality from breast cancer, and the lifetime cost of health care for women with non-obstructive chest pain is close to $1 million. Coronary microvascular dysfunction is a major etiological feature of this disease, and may contribute to disease progression. Despite our general understanding, effective treatment remains elusive. This pilot study will test whether regular exercise training can improve/reverse coronary microvascular dysfunction in women with angina but no obstructive coronary artery disease.
Read the detailed description
We will study 10 women with signs and symptoms of ischemia but no evidence of obstructive coronary artery disease.
Procedures:
Aerobic fitness: Incremental exercise test to volitional exhaustion on a exercise bike to assess the maximal rate of oxygen consumption.
Cardiac magnetic resonance imaging: To assess cardiac morphology and function. Cardiac perfusion imaging: Using MRI, we will assess the rate of uptake of a contrast media (gadolinium) at rest and in response to a vasodilating substance (adenosine) to evaluate myocardial perfusion reserve.
Protocol:
Participants will undergo aerobic fitness testing, cardiac MRI and perfusion imaging at baseline and following 8-weeks of regular exercise training.
- Conditions
- Microvascular Coronary Dysfunction
- Being tested
- Exercise training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Exercise Training | Experimental | Subjects will exercise for 8 weeks Receives: Behavioral: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the maximal rate of myocardial oxygen consumption
Measured: Change from baseline at 8 weeks
Secondary outcomes (2)
Change in myocardial perfusion reserve index
Measured: change from baseline at 8 weeks
Change in left ventricular diastolic function
Measured: change from baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startJan 2016
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Enrollment slower than usual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microvascular Coronary DysfunctionStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noel Bairey Merz, Cedars-Sinai Medical Center
- Investigators
- C. Noel Bairey Merz, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374086
- Sponsor's protocol ID
- PRO37771
- Status last verified
- Apr 2019
- First submitted
- 18 Feb 2015
- Last updated
- 23 Apr 2019
- Results posted
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Test the Benefits of Exercise Training in Women With Ischemic Syndrome
- ClinicalTrials.gov ID
- NCT02374086
- Acronym / sponsor ID
- PRO37771
- Conditions
- Microvascular Coronary Dysfunction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Enrollment slower than usual.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 27 Feb 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.
Angina in the absence of obstructive coronary artery disease is highly prevalent in women, and leads to increased risk for major cardiovascular events, including myocardial infarction, stroke, and heart failure. Annual mortality rates are ten-fold higher than mortality from breast cancer, and the lifetime cost of health care for women with non-obstructive chest pain is close to $1 million. Coronary microvascular dysfunction is a major etiological feature of this disease, and may contribute to disease progression. Despite our general understanding, effective treatment remains elusive. This pilot study will test whether regular exercise training can improve/reverse coronary microvascular dysfunction in women with angina but no obstructive coronary artery disease.
Detailed description
We will study 10 women with signs and symptoms of ischemia but no evidence of obstructive coronary artery disease.
Procedures:
Aerobic fitness: Incremental exercise test to volitional exhaustion on a exercise bike to assess the maximal rate of oxygen consumption.
Cardiac magnetic resonance imaging: To assess cardiac morphology and function. Cardiac perfusion imaging: Using MRI, we will assess the rate of uptake of a contrast media (gadolinium) at rest and in response to a vasodilating substance (adenosine) to evaluate myocardial perfusion reserve.
Protocol:
Participants will undergo aerobic fitness testing, cardiac MRI and perfusion imaging at baseline and following 8-weeks of regular exercise training.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Training | Experimental | Behavioral: Exercise trainingSubjects will exercise for 8 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women with persistent chest pain but no obstructive disease (defined as 50% luminal diameter stenosis in >1 epicardial coronary arteries)
- Fully understanding and willing to undergo study procedures
- Understanding and willing to sign consent form.
Key exclusion criteria (17 listed)
- Acute coronary syndrome (defined by WHO), cardiogenic shock or requiring inotropic or intra-aortic balloon support;
- Planned percutaneous coronary intervention or coronary artery bypass graft or established obstructive CAD with ischemia eligible for revascularization,
- Acute myocardial infarction;
- Patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support;
- Prior non-cardiac illness with an estimated life expectancy <4 years;
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 |
|---|---|---|
| Exercise training | Behavioural | Exercise Training |
Primary outcome
Change in the maximal rate of myocardial oxygen consumption
Time frame: Change from baseline at 8 weeks
2 secondary outcomes
Change in myocardial perfusion reserve index
Time frame: change from baseline at 8 weeks
Change in left ventricular diastolic function
Time frame: change from baseline at 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Individual participant dataSharing planned: Yes
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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.
C. Noel Bairey Merz, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Microvascular Coronary Dysfunction, run by Cedars-Sinai Medical Center 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 17 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: withdrawn, as of the sponsor's last update on 23 Apr 2019. 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 was withdrawn before enrolling participants, so there are no results.
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 the maximal rate of myocardial oxygen consumption (time frame: Change from baseline at 8 weeks). 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 23 Apr 2019.