Recruiting

Coronary Microvascular Dysfunction

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT02301663

Conditions

Microvascular Coronary Dysfunction

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Handgrip

Altitude simulation

Leg exercise

Study Details

Brief summary:

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.

Conditions

Microvascular Coronary Dysfunction

Study ID

NCT02301663

Start date

Nov, 2014

Status verified date

Aug, 2023

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Fully understanding and willing to undergo study procedures
2. Male or Female greater than or equal to 18 years of age
3. Understanding and willing to sign consent form.

Exclusion Criteria:

1. History of cardiovascular, pulmonary, or neurological disease
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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

  • Diastolic function by MRI [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Barbra Streisand Women's Heart Center

310-423-9666

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Sep 1, 2023

Last verified

Aug, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2023-09-01.