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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

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ClinicalTrials.gov Identifier: NCT02301663
Recruitment Status : Recruiting
First Posted : November 26, 2014
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Noel Bairey Merz, 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.

Condition or disease Intervention/treatment Phase
Microvascular Coronary Dysfunction Other: Handgrip Other: Altitude simulation Other: Leg exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : November 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Diastolic function by MRI [ Time Frame: 24 hours ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301663


Contacts
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Contact: Ying Mou, PhD 310-248-7669 ying.mou@cshs.org
Contact: Sophie Yoo, MS 424-315-4306 Jihye.Yoo@cshs.org

Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Ying Mou, PhD    310-248-7669    ying.mou@cshs.org   
Contact: Sophie Yoo, MS    424-315-4306    Jihye.Yoo@cshs.org   
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Michael Nelson, PhD Cedars-Sinai Medical Center

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Responsible Party: Noel Bairey Merz, Director, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02301663     History of Changes
Other Study ID Numbers: Diastolic stress testing
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases