Development of a Novel Stress Testing Protocol to Define the Relationship Between Coronary Microvascular Dysfunction and Diastology in Women With Angina But No Evidence of Obstructive Coronary Artery Disease
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Cedars-Sinai Medical Center
- Study ID
- NCT02301663
- Status
- Recruiting
Conditions
- Microvascular Coronary Dysfunction
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 60 Years
- Healthy Volunteers
- Accepted
Interventions
- Handgrip — OTHERSubjects will be asked to squeeze and handgrip dynamometer to increase cardiac metabolic demand
- Altitude simulation — OTHERSubjects will breathe a lower concentration of oxygen to simulate the effects of altitude.
- Leg exercise — OTHERSubjects will perform leg exercise to increase metabolic demand.
Study Details
Microvascular coronary dysfunction (MCD) (abnormities in small blood vessels/arteries in heart) with symptoms of persistent chest pain, primarily impacts women. There are an estimated 2-3 million women in the US with MCD and about 100,000 new cases annually. Recent data from our research group suggests that coronary microvascular disease impairs the way the heart relaxes. This pilot study will attempt to exacerbate this phenotype in an effort to better understand the pathophysiology of the disease. The investigators will recruit 30 volunteers total (10 healthy calibration subjects, 10 women with microvascular disease, and 10 age-match women for the group with microvascular disease). Subjects will undergo a series of "stress" maneuvers in conjunction with advanced cardiac magnetic resonance imaging.
Key Dates
- Start date
- Nov 30, 2014
- Status verified
- Aug 2023
- Primary completion
- Dec 31, 2030
- Completion
- Dec 31, 2030
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: Women w/microvascular disease10 women with microvascular disease
- Experimental: Normal controls10 age-matched women with no evidence of microvascular disease
- Experimental: calibration10 healthy individuals who will help to synchronize our imaging and stress testing maneuvers.
Primary Outcome Measure
Diastolic function by MRI [ Time Frame: 24 hours ]
Central Contacts
- Barbra Streisand Women's Heart Center310-423-9666
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 |
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