Benefits of Exercise Training in Women With Ischemic Syndrome

Withdrawn before enrolling · Not applicable

Conditions studied: Microvascular Coronary Dysfunction

In brief

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.

Key facts

Study ID

NCT02374086

Run by

Cedars-Sinai Medical Center

People needed

0

Starts

2016-01-01

Expected to finish

2016-10-01

Last updated by the study team

2019-04-23

Who can join

Age: 18 and older, up to 60. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;
• 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

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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