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

NCT02301663 | Recruiting

• 1 other identifier: Diastolic stress testing
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Microvascular Coronary Dysfunction

Outcome Measures

Primary Outcomes (1)

• Diastolic function by MRI

  24 hours

Study Arms (3)

Women w/microvascular disease

EXPERIMENTAL

10 women with microvascular disease

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

Normal controls

EXPERIMENTAL

10 age-matched women with no evidence of microvascular disease

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

calibration

EXPERIMENTAL

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

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

Interventions

Handgrip OTHER

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

Normal controls; Women w/microvascular disease; calibration

Altitude simulation OTHER

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

Normal controls; Women w/microvascular disease; calibration

Leg exercise OTHER

Subjects will perform leg exercise to increase metabolic demand.

Normal controls; Women w/microvascular disease; calibration

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Study Officials

• Michael Nelson, PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbra Streisand Women's Heart Center

CONTACT

310-423-9666

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 22, 2014
• First Posted: November 26, 2014
• Study Start: November 1, 2014
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)