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

Not Applicable

Recruiting

• Conditions: Microvascular Coronary Dysfunction
• Interventions: Other: Handgrip; Other: Altitude simulation; Other: Leg exercise

• Registration Number: NCT02301663
• Lead Sponsor: Cedars-Sinai Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-22
• Study First Submitted QC: 2014-11-25
• Study First Posted: 2014-11-26
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-01
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal controls	Altitude simulation	10 age-matched women with no evidence of microvascular disease
Women w/microvascular disease	Handgrip	10 women with microvascular disease
Normal controls	Leg exercise	10 age-matched women with no evidence of microvascular disease
calibration	Altitude simulation	10 healthy individuals who will help to synchronize our imaging and stress testing maneuvers.
Women w/microvascular disease	Altitude simulation	10 women with microvascular disease
Women w/microvascular disease	Leg exercise	10 women with microvascular disease
Normal controls	Handgrip	10 age-matched women with no evidence of microvascular disease
calibration	Handgrip	10 healthy individuals who will help to synchronize our imaging and stress testing maneuvers.
calibration	Leg exercise	10 healthy individuals who will help to synchronize our imaging and stress testing maneuvers.

Primary Outcome Measures

Name	Time	Method
Diastolic function by MRI	24 hours

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States