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

Cedars-Sinai Medical Center

Status: Enrolling

Conditions: Microvascular Coronary Dysfunction

Treatments: Other: Altitude simulation; Other: Handgrip; Other: Leg exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT02301663

Diastolic stress testing

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 3 patient groups

Women w/microvascular disease

Experimental group

Description:

10 women with microvascular disease

Treatment:

Other: Handgrip

Other: Leg exercise

Other: Altitude simulation

Normal controls

Experimental group

Description:

10 age-matched women with no evidence of microvascular disease

Treatment:

Other: Handgrip

Other: Leg exercise

Other: Altitude simulation

calibration

Experimental group

Description:

10 healthy individuals who will help to synchronize our imaging and stress testing maneuvers.

Treatment:

Other: Handgrip

Other: Leg exercise

Other: Altitude simulation