An interventional study of Exercise training in Microvascular Coronary Dysfunction, sponsored by Cedars-Sinai Medical Center. Withdrawn at 1 site in United States. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-04-23.
Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Treatment
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.
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.
Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will exercise for 8 weeks
Behavioral: Exercise training
Change in the maximal rate of myocardial oxygen consumption
Time frame: Change from baseline at 8 weeks
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
Plan to share: Yes
No publications or documents are linked to this record.
This study is withdrawn, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Cedars-Sinai Medical Center