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

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.

Study Overview

• Status: Recruiting
• Conditions: Microvascular Coronary Dysfunction
• Intervention / Treatment: Other: Handgrip; Other: Altitude simulation; Other: Leg exercise

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Barbra Streisand Women's Heart Center; Phone Number: 310-423-9666

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center
      • Contact: Nicole Tovar; Phone Number: 310-248-6960; Email: nicole.tovar@cshs.org
      • Contact: BS WHC, MS; Phone Number: 310-423-9666; Email: bswhc.research@cshs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Women w/microvascular disease; 10 women with microvascular disease	Other: Handgrip; Subjects will be asked to squeeze and handgrip dynamometer to increase cardiac metabolic demand; Other: Altitude simulation; Subjects will breathe a lower concentration of oxygen to simulate the effects of altitude.; Other: Leg exercise; Subjects will perform leg exercise to increase metabolic demand.
Experimental: Normal controls; 10 age-matched women with no evidence of microvascular disease	Other: Handgrip; Subjects will be asked to squeeze and handgrip dynamometer to increase cardiac metabolic demand; Other: Altitude simulation; Subjects will breathe a lower concentration of oxygen to simulate the effects of altitude.; Other: Leg exercise; Subjects will perform leg exercise to increase metabolic demand.
Experimental: calibration; 10 healthy individuals who will help to synchronize our imaging and stress testing maneuvers.	Other: Handgrip; Subjects will be asked to squeeze and handgrip dynamometer to increase cardiac metabolic demand; Other: Altitude simulation; Subjects will breathe a lower concentration of oxygen to simulate the effects of altitude.; Other: Leg exercise; Subjects will perform leg exercise to increase metabolic demand.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diastolic function by MRI	24 hours

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Michael Nelson, PhD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: November 22, 2014
• First Submitted That Met QC Criteria: November 25, 2014
• First Posted (Estimated): November 26, 2014

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: Diastolic stress testing

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES