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

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02301663

Enrollment

Registered

2014-11-26

Start date

2014-11-30

Completion date

2030-12-31

Last updated

2023-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microvascular Coronary Dysfunction

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.

Interventions

OTHERHandgrip

Subjects will be asked to squeeze and handgrip dynamometer to increase cardiac metabolic demand

OTHERAltitude simulation

Subjects will breathe a lower concentration of oxygen to simulate the effects of altitude.

OTHERLeg exercise

Subjects will perform leg exercise to increase metabolic demand.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Diastolic function by MRI	24 hours

Countries

United States

Contacts

Primary ContactBarbra Streisand Women's Heart Center

310-423-9666

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026