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 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02301663
• Other study ID #: Diastolic stress testing
• Status: Recruiting
• Phase: N/A
• Start date: November 2014
• Est. completion date: December 2030

Study information

• Verified date: August 2023
• Source: Cedars-Sinai Medical Center
• Contact: Barbra Streisand Women's Heart Center
• Phone: 310-423-9666
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Microvascular Coronary Dysfunction
• Myocardial Ischemia

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diastolic function by MRI		24 hours