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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Handgrip, Altitude simulation, Leg exercise.
- Who it may be relevant to
- Registry conditions: Microvascular Coronary Dysfunction. Basic parameters: 18 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Other Handgrip
Subjects will be asked to squeeze and handgrip dynamometer to increase cardiac metabolic demand - Other Altitude simulation
Subjects will breathe a lower concentration of oxygen to simulate the effects of altitude. - Other Leg exercise
Subjects will perform leg exercise to increase metabolic demand.
Primary outcome measures
- Diastolic function by MRI [Time frame: 24 hours]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Cedars-Sinai Medical Center — Los Angeles
Identifiers
NCT: NCT02301663 · Diastolic stress testing