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Cardiac Autonomic Function in Women With Microvascular Coronary Dysfunction

This study is currently recruiting participants.
Verified July 2017 by Noel Bairey Merz, Cedars-Sinai Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01568177
First Posted: April 2, 2012
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Noel Bairey Merz, Cedars-Sinai Medical Center
  Purpose
Microvascular coronary dysfunction (MCD) (abnormities in small blood vessels/arteries in heart) with symptoms of persistent chest pain impacts women. There are an estimated 2-3 million women in the US with MCD and about 100,000 new cases annually. Autonomic nervous system (ANS) is part of the central nervous system to help people adapt to changes in their environment. It controls what are normally involuntary activities, such as heart rate, respiration (breathing), body temperature, blood pressure, and urinary function. However, there is a limited understanding of the role of ANS in MCD. This research is proposed to investigate cardiovascular reactivity to mental stress and the cardiac (heart) nervous system in women with MCD using mental stress testing, peripheral vascular testing, advanced cardiac imaging and cardiac autonomic function testing. 100 participants will be recruited in the next five years.

Condition Intervention
Microvascular Coronary Dysfunction Behavioral: Mental Stress Testing Other: Peripheral Arterial Tonometry (PAT) Testing Other: Heart Rate Variability (HRV) Other: RESPeRATE Breathing Trial Procedure: SPECT cardiac scan with 123I-mIBG and Myoview

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cardiac Autonomic Function in Women With Microvascular Coronary Dysfunction

Further study details as provided by Noel Bairey Merz, Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Cardiovascular Reactivity (CVR) [ Time Frame: 24 hours ]
    Cardiovascular Reactivity (CVR)


Estimated Enrollment: 60
Study Start Date: February 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
abnormal CRT

40 subjects with microvascular coronary dysfunction (MCD) defined as abnormal CRT.

Visits 1, 2, and 3

Behavioral: Mental Stress Testing
Mental stress testing is used to test the mechanistic pathways through which biobehavioral variables are involved in the pathogenesis of MCD in women.
Other: Peripheral Arterial Tonometry (PAT) Testing
PAT measurements will be used to predict ischemia in patients with MCD. PAT will be measured by Endo PAT 2000 (Itamar® Medical Ltd).
Other: Heart Rate Variability (HRV)
Holter monitor will be used to measure heart rate and rhythm for approximately 24 hours.
Other: RESPeRATE Breathing Trial
RESPeRATE Breathing will test whether a controlled breathing relaxation technique using an FDA-approved paced breathing device, RESPeRATE, helps with chest pain and shortness of breath and will test to see if this form of biofeedback or relaxation technique helps with heart rate variability during mental stress.
Procedure: SPECT cardiac scan with 123I-mIBG and Myoview
Single Photon Emission Computed Tomography (SPECT) cardiac scan with 123I-mIBG and Myoview will be used to measure cardiac sympathetic activity.
Cardiac Syndrome X
20 subjects with symptoms and normal stress tests, no MCD. Visits 1 and 2
Behavioral: Mental Stress Testing
Mental stress testing is used to test the mechanistic pathways through which biobehavioral variables are involved in the pathogenesis of MCD in women.
Other: Peripheral Arterial Tonometry (PAT) Testing
PAT measurements will be used to predict ischemia in patients with MCD. PAT will be measured by Endo PAT 2000 (Itamar® Medical Ltd).
Other: Heart Rate Variability (HRV)
Holter monitor will be used to measure heart rate and rhythm for approximately 24 hours.
Other: RESPeRATE Breathing Trial
RESPeRATE Breathing will test whether a controlled breathing relaxation technique using an FDA-approved paced breathing device, RESPeRATE, helps with chest pain and shortness of breath and will test to see if this form of biofeedback or relaxation technique helps with heart rate variability during mental stress.
Procedure: SPECT cardiac scan with 123I-mIBG and Myoview
Single Photon Emission Computed Tomography (SPECT) cardiac scan with 123I-mIBG and Myoview will be used to measure cardiac sympathetic activity.
normal reference controls
40 normal reference controls subjects Visits 1 and 2
Behavioral: Mental Stress Testing
Mental stress testing is used to test the mechanistic pathways through which biobehavioral variables are involved in the pathogenesis of MCD in women.
Other: Peripheral Arterial Tonometry (PAT) Testing
PAT measurements will be used to predict ischemia in patients with MCD. PAT will be measured by Endo PAT 2000 (Itamar® Medical Ltd).
Other: Heart Rate Variability (HRV)
Holter monitor will be used to measure heart rate and rhythm for approximately 24 hours.
Other: RESPeRATE Breathing Trial
RESPeRATE Breathing will test whether a controlled breathing relaxation technique using an FDA-approved paced breathing device, RESPeRATE, helps with chest pain and shortness of breath and will test to see if this form of biofeedback or relaxation technique helps with heart rate variability during mental stress.
Procedure: SPECT cardiac scan with 123I-mIBG and Myoview
Single Photon Emission Computed Tomography (SPECT) cardiac scan with 123I-mIBG and Myoview will be used to measure cardiac sympathetic activity.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Inclusion criteria for Protocol 14906:

  • Women with symptomatic angina or angina equivalent;
  • Age > 18 yrs old;
  • No obstructive CAD at coronary angiography (performed within the previous 24 months);
  • Competent to give informed consent.

Inclusion criteria for Protocol 11753:

  • Women without signs and symptoms of myocardial ischemia (chest pain, abnormal stress testing, abnormal noninvasive testing);
  • No cardiac risk factors by Framingham/NCEP criteria;
  • Age (35-65) matched to the WISE MCD population;
  • A normal maximal exercise stress test.

Exclusion Criteria:

Exclusion criteria for Protocol 14906:

  • Obstructive CAD greater than or equal to 50% luminal diameter stenosis in greater than or equal to 1 epicardial coronary artery;
  • Acute coronary syndrome (defined by the ACC/AHA criteria, Braunwald 2000);
  • Primary valvular heart disease clearly indicating the need for valve repair or replacement;
  • Patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support;
  • Prior or planned percutaneous coronary intervention or CABG;
  • Acute MI;
  • Prior non-cardiac illness with an estimated life expectancy < 4 years;
  • Unable to give informed consent;
  • Chest pain with a non-ischemic etiology (e.g.,pericarditis, pneumonia, esophageal spasm);
  • Contraindications to CMRI (e.g., AICD, pacemaker, untreatable claustrophobia or known angio-edema);
  • Women with intermediate coronary stenoses (> 20% but < 50% luminal diameter stenosis assessed visually at the time of angiography) will undergo clinically indicated IVUS testing based on the judgement of the operator; Those determined to have flow-obstructing stenosis will be excluded from the overall study;
  • Participation in a research study that conflicts with the current WISE study.
  • Women with coronary stenosis ≥50% in any epicardial coronary artery, assessed visually at the time of angiography, will not be included in the CRT subgroup.
  • Women who are pregnant.
  • Males

Exclusion criteria for Protocol 11753:

  • Contraindications to CMR testing (metal devices in chest, claustrophobia, known angioedema);
  • Contraindication to Adenosine including asthma, heart block (second and third degree) and sinus node disease, significant COPD/asthma, or systemic hypotension (<90mmHg);
  • Contraindication to Dobutamine including severe systemic hypertension (≥ 220/120 mmHg), unstable angina, significant aortic valve stenosis, complex cardiac arrhythmia including uncontrolled atrial fibrillation, hypertrophic obstructive cardiomyopathy, myocarditis, endocarditis, pericarditis, or uncontrolled congestive heart failure;
  • Contraindication to Gadolinium (renal impairment);
  • Any renal disease;
  • Pregnant and lactating women;
  • Inability to perform exercise, e.g. orthopedic limitations.
  Contacts and Locations
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): NCT01568177


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

Locations
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
Principal Investigator: C. Noel Bairey Merz, M.D. Cedars-Sinai Medical Center
Principal Investigator: Puja Mehta, M.D. Emory University
  More Information

Responsible Party: Noel Bairey Merz, Director, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01568177     History of Changes
Other Study ID Numbers: 22264
First Submitted: March 29, 2012
First Posted: April 2, 2012
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Noel Bairey Merz, Cedars-Sinai Medical Center:
MCD

Additional relevant MeSH terms:
Technetium tc-99m tetrofosmin
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action