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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Microvascular Coronary Dysfunction

Intervention / Treatment
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* Other: Handgrip
* Other: Altitude simulation
* Other: Leg exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fully understanding and willing to undergo study procedures Male or Female greater than or equal to 18 years of age Understanding and willing to sign consent form. Exclusion Criteria: History of cardiovascular, pulmonary, or neurological disease Hypertension (sitting blood pressure >140/90 mmHg, with measurements recorded on at least 2 occasions) Diabetes Unable to give informed consent; Contra-indication to CMRI testing, including claustrophobia and metallic implants Adherence or retention issues; Women who are pregnant. Allergy to animal dander.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Women w/microvascular disease<br>10 women with microvascular disease | Other: Handgrip<br>* Subjects will be asked to squeeze and handgrip dynamometer to increase cardiac metabolic demand<br>Other: Altitude simulation<br>* Subjects will breathe a lower concentration of oxygen to simulate the effects of altitude.<br>Other: Leg exercise<br>* Subjects will perform leg exercise to increase metabolic demand.<br>|
| Experimental: Normal controls<br>10 age-matched women with no evidence of microvascular disease | Other: Handgrip<br>* Subjects will be asked to squeeze and handgrip dynamometer to increase cardiac metabolic demand<br>Other: Altitude simulation<br>* Subjects will breathe a lower concentration of oxygen to simulate the effects of altitude.<br>Other: Leg exercise<br>* Subjects will perform leg exercise to increase metabolic demand.<br>|
| Experimental: calibration<br>10 healthy individuals who will help to synchronize our imaging and stress testing maneuvers. | Other: Handgrip<br>* Subjects will be asked to squeeze and handgrip dynamometer to increase cardiac metabolic demand<br>Other: Altitude simulation<br>* Subjects will breathe a lower concentration of oxygen to simulate the effects of altitude.<br>Other: Leg exercise<br>* Subjects will perform leg exercise to increase metabolic demand.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diastolic function by MRI |  | 24 hours |