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
NCT ID: NCT02301663
Last Updated: 2023-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2014-11-30
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Women w/microvascular disease
10 women with microvascular disease
Handgrip
Subjects will be asked to squeeze and handgrip dynamometer to increase cardiac metabolic demand
Altitude simulation
Subjects will breathe a lower concentration of oxygen to simulate the effects of altitude.
Leg exercise
Subjects will perform leg exercise to increase metabolic demand.
Normal controls
10 age-matched women with no evidence of microvascular disease
Handgrip
Subjects will be asked to squeeze and handgrip dynamometer to increase cardiac metabolic demand
Altitude simulation
Subjects will breathe a lower concentration of oxygen to simulate the effects of altitude.
Leg exercise
Subjects will perform leg exercise to increase metabolic demand.
calibration
10 healthy individuals who will help to synchronize our imaging and stress testing maneuvers.
Handgrip
Subjects will be asked to squeeze and handgrip dynamometer to increase cardiac metabolic demand
Altitude simulation
Subjects will breathe a lower concentration of oxygen to simulate the effects of altitude.
Leg exercise
Subjects will perform leg exercise to increase metabolic demand.
Interventions
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Handgrip
Subjects will be asked to squeeze and handgrip dynamometer to increase cardiac metabolic demand
Altitude simulation
Subjects will breathe a lower concentration of oxygen to simulate the effects of altitude.
Leg exercise
Subjects will perform leg exercise to increase metabolic demand.
Eligibility Criteria
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Inclusion Criteria
2. Male or Female greater than or equal to 18 years of age
3. Understanding and willing to sign consent form.
Exclusion Criteria
2. Hypertension (sitting blood pressure \>140/90 mmHg, with measurements recorded on at least 2 occasions)
3. Diabetes
4. Unable to give informed consent;
5. Contra-indication to CMRI testing, including claustrophobia and metallic implants
6. Adherence or retention issues;
7. Women who are pregnant.
8. Allergy to animal dander.
18 Years
60 Years
FEMALE
Yes
Sponsors
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Cedars-Sinai Medical Center
OTHER
Responsible Party
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Noel Bairey Merz
Director
Principal Investigators
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Michael Nelson, PhD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Countries
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Central Contacts
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Barbra Streisand Women's Heart Center
Role: CONTACT
Facility Contacts
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Other Identifiers
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Diastolic stress testing
Identifier Type: -
Identifier Source: org_study_id
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