Cardiac Autonomic Function in Women With Microvascular Coronary Dysfunction

This study is currently recruiting participants.
Verified May 2013 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: May 6, 2013
Last verified: May 2013
  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 the heart ANS in the MCD. This pilot research is proposed to investigate cardiovascular (hear artery) 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.60 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
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

Resource links provided by NLM:


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
20 subjects with microvascular coronary dysfunction (MCD) defined as abnormal CRT
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).
normal CRT
20 subjects with normal CRT
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).
normal reference controls
20 normal reference controls subjects
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).

Detailed Description:

There are three groups of 20 participants each.

Recruiting participants from Protocol 14906:

To date, no participants from Protocol 14906 have completed the study yet. All the participants who are currently enrolled in 14906 will be approached by the investigator at their next study visits. Prospectively new participants will be approached while they are consented for 14906.

Recruiting participants from Protocol 11753:

All the participants of Protocol 11753 are Cedars employees. Participants who are currently enrolled in Protocol 11753 will be approached at their next study visits. Prospectively new participants will be approached while they are consented for 11753. Research staff may also identify past patients who have completed 11753 and fulfill the requirements for healthy individuals. They will be contacted by an introductory letter providing basic information about the study with the option not to be contacted by a member of the research staff regarding the study. If they decide to participate in the study, they will be given a detailed description about the study and asked to come for a screening evaluation. The introductory letter will be sent to their Cedars working address, not home address.

All participants will be asked to undergo research procedures including mental stress tasks, HRV, cold pressor testing, PAT and BART. These procedures are described below:

Mental Stress Testing Mental Stress Testing will be used to study what happens to heart rate, blood pressure, heart rhythm, and blood vessels in arms and hands when participants are in a stressful situation. It will take up to 90 minutes to complete all the procedures in the mental stress testing including the following specific procedures: In Mental Stress Tasks, different types of stress testing, including a speech task over a situation that made participants upset or angry, and/or a math test involving adding or subtracting numbers under a specific constraint, and/or a memory test, will be administered to study the effect of stress on heart; In Heart Rate Variability (HRV), participants will be asked to wear a holter monitor that measures heart rate and rhythm for approximately 24 hours; In Cold Pressor Testing, participants' heart rate, blood pressure, heart rhythm, and blood vessels will be monitored and measured; In Peripheral Arterial Tonometry (PAT), a blood pressure cuff will be placed on one arm and probes will be placed on participants' fingers. The probes and cuff are attached to a monitoring device that transfers a waveform graph of participants' pulse. Then the blood pressure cuff will be inflated for 5 minutes and more recordings will be done. At the end of the 5-minute period, the blood pressure cuff will be deflated to get the final tracings; In Brachial Artery Reactivity Test (BART), BART is used to see how well the artery responds to stress by how much it dilates and how much it increases blood flow through the blood vessel.

All the procedures are research-related. All of the research-related procedures may be completed in one visit. However, if participants cannot complete all of the procedures in one visit, a second visit is allowed for them to complete the study-related procedures. Participants may consent to some but not all of the procedures due to our current limited funding.

There are no collaborations with other sites.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Inclusion criteria for Protocol 14906:

  • Symptomatic angina or anginal equivalent
  • Females, aged 18 or older
  • 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.
  • Women with coronary stenosis greater than or equal to 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.
  • Contraindication to Gadolinium (renal impairment).
  • Any renal disease.
  • Pregnant and lactating women.
  • Inability to perform exercise, e.g. orthopedic limitations.
  Contacts and Locations
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

No publications provided

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: May 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
MCD

ClinicalTrials.gov processed this record on April 17, 2014