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Cardiac Autonomic Function in Women With Microvascular Coronary Dysfunction

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Cedars-Sinai Medical Center
Sponsor:
Information provided by (Responsible Party):
Noel Bairey Merz, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01568177
First received: March 29, 2012
Last updated: October 18, 2016
Last verified: October 2016
  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 Phase
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
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Cardiac Autonomic Function in Women With Microvascular Coronary Dysfunction

Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Cardiovascular Reactivity (CVR) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01568177

Contacts
Contact: Puja Mehta, M.D. 3104239666 puja.mehta@cshs.org
Contact: Ying Mou, PhD 3102487669 ying.mou@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: Rosario Ando    3104239666    rosario.ando@cshs.org   
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Puja Mehta, M.D. Cedars-Sinai Medical Center
  More Information

Responsible Party: Noel Bairey Merz, Director, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01568177     History of Changes
Other Study ID Numbers: 22264 
Study First Received: March 29, 2012
Last Updated: October 18, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
MCD

Additional relevant MeSH terms:
Technetium Tc 99m 1,2-bis(bis(2-ethoxyethyl)phosphino)ethane
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 02, 2016