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 — OTHER
    Subjects will be asked to squeeze and handgrip dynamometer to increase cardiac metabolic demand
  • Altitude simulation — OTHER
    Subjects will breathe a lower concentration of oxygen to simulate the effects of altitude.
  • Leg exercise — OTHER
    Subjects 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 disease
    10 women with microvascular disease
  • Experimental: Normal controls
    10 age-matched women with no evidence of microvascular disease
  • Experimental: calibration
    10 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 Center
    310-423-9666

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Nicole Tovar
310-248-6960
BS WHC, MS
310-423-9666

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