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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

Primary Purpose

Microvascular Coronary Dysfunction

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Handgrip
Altitude simulation
Leg exercise
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Microvascular Coronary Dysfunction

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts 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.

Sites / Locations

  • Cedars-Sinai Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Women w/microvascular disease

Normal controls

calibration

Arm Description

10 women with microvascular disease

10 age-matched women with no evidence of microvascular disease

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

Outcomes

Primary Outcome Measures

Diastolic function by MRI

Secondary Outcome Measures

Full Information

First Posted
November 22, 2014
Last Updated
August 31, 2023
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02301663
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2030 (Anticipated)
Study Completion Date
December 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microvascular Coronary Dysfunction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Women w/microvascular disease
Arm Type
Experimental
Arm Description
10 women with microvascular disease
Arm Title
Normal controls
Arm Type
Experimental
Arm Description
10 age-matched women with no evidence of microvascular disease
Arm Title
calibration
Arm Type
Experimental
Arm Description
10 healthy individuals who will help to synchronize our imaging and stress testing maneuvers.
Intervention Type
Other
Intervention Name(s)
Handgrip
Intervention Description
Subjects will be asked to squeeze and handgrip dynamometer to increase cardiac metabolic demand
Intervention Type
Other
Intervention Name(s)
Altitude simulation
Intervention Description
Subjects will breathe a lower concentration of oxygen to simulate the effects of altitude.
Intervention Type
Other
Intervention Name(s)
Leg exercise
Intervention Description
Subjects will perform leg exercise to increase metabolic demand.
Primary Outcome Measure Information:
Title
Diastolic function by MRI
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbra Streisand Women's Heart Center
Phone
310-423-9666
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Nelson, PhD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Tovar
Phone
310-248-6960
Email
nicole.tovar@cshs.org
First Name & Middle Initial & Last Name & Degree
BS WHC, MS
Phone
310-423-9666
Email
bswhc.research@cshs.org

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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