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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorCedars-Sinai Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Handgrip

    Other intervention

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

  • Altitude simulation

    Other intervention

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

  • Leg exercise

    Other intervention

    Subjects will perform leg exercise to increase metabolic demand.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Women w/microvascular diseaseExperimental treatment 3 interventions
Group B: Normal controlsExperimental treatment 3 interventions
Group C: calibrationExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Diastolic function by MRI

Time frame
24 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.