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NCT Number: NCT02301663

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

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.

Recruiting

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Key information

Conditions

Microvascular Coronary Dysfunction

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Contra-indication to CMRI testing, including claustrophobia and metallic implants
  • Adherence or retention issues;
  • Women who are pregnant.
  • Allergy to animal dander.

Treatment and study plan

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.

Primary outcomes

  1. Diastolic function by MRI

    Time frame: 24 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Barbra Streisand Women's Heart Center

CONTACT

310-423-9666

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2030
Study completion
2030
First posted
Nov 26, 2014
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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