Expired Study
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Los Angeles, California 90048


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: 1. Women with persistent chest pain but no obstructive disease (defined as 50% luminal diameter stenosis in >1 epicardial coronary arteries) 2. Fully understanding and willing to undergo study procedures 3. Understanding and willing to sign consent form. Exclusion Criteria: 1. Acute coronary syndrome (defined by WHO), cardiogenic shock or requiring inotropic or intra-aortic balloon support; 2. Planned percutaneous coronary intervention or coronary artery bypass graft or established obstructive CAD with ischemia eligible for revascularization, 3. Acute myocardial infarction; 4. Patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support; 5. Prior non-cardiac illness with an estimated life expectancy <4 years; 6. Unable to give informed consent; 7. 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; 8. Contraindications to adenosine or regadensoson (Lexiscan) 9. Surgically uncorrected significant congenital or valvular heart disease and other disease likely to be fatal or require frequent hospitalization within the next six months; 10. Adherence or retention issues; 11. Unwilling to complete follow-up evaluation; 12. Aortic stenosis (valve area <1.5cm); 13. Left ventricular systolic dysfunction (ejection fraction <35%); 14. Taking potent CYP3A4 inhibitors (ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir); 15. Women who are pregnant. 16. Allergy to animal dander. 17. Unable to perform exercise


Study is Available At:


Original ID:

PRO37771


NCT ID:

NCT02374086


Secondary ID:


Study Acronym:


Brief Title:

Benefits of Exercise Training in Women With Ischemic Syndrome


Official Title:

A Pilot Study to Test the Benefits of Exercise Training in Women With Ischemic Syndrome


Overall Status:

Withdrawn


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

60 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Cedars-Sinai Medical Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Enrollment slower than usual.


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:C. Noel Bairey Merz, MD
Principal Investigator
Cedars-Sinai Medical Center

Study Dates

Start Date:January 2016
Completion Date:October 2016
Completion Type:Actual
Primary Completion Date:October 2016
Primary Completion Type:Actual
Verification Date:April 2019
Last Changed Date:April 22, 2019
First Received Date:February 18, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change in the maximal rate of myocardial oxygen consumption
Time Frame:Change from baseline at 8 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in myocardial perfusion reserve index
Time Frame:change from baseline at 8 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in left ventricular diastolic function
Time Frame:change from baseline at 8 weeks
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Exercise training
Arm Name:Exercise Training

Study Arms

Study Arm Type:Experimental
Arm Name:Exercise Training
Description:Subjects will exercise for 8 weeks

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Cedars-Sinai Medical Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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