Cardiac Autonomic Function in Women with Microvascular Coronary Dysfunction

NCT01568177 | Completed

• 1 other identifier: 22264
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Microvascular Coronary Dysfunction

Keywords

MCD

Outcome Measures

Primary Outcomes (1)

• Cardiovascular Reactivity (CVR)

  Cardiovascular Reactivity (CVR)

  24 hours

Study Arms (3)

abnormal CRT

OTHER

40 subjects with microvascular coronary dysfunction (MCD) defined as abnormal CRT. Visits 1, 2, and 3

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

Cardiac Syndrome X

OTHER

20 subjects with symptoms and normal stress tests, no MCD. Visits 1 and 2

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

normal reference controls

OTHER

40 normal reference controls subjects Visits 1 and 2

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

Interventions

Mental Stress Testing BEHAVIORAL

Mental stress testing is used to test the mechanistic pathways through which biobehavioral variables are involved in the pathogenesis of MCD in women.

Cardiac Syndrome X; abnormal CRT; normal reference controls

Peripheral Arterial Tonometry (PAT) Testing OTHER

PAT measurements will be used to predict ischemia in patients with MCD. PAT will be measured by Endo PAT 2000 (Itamar® Medical Ltd).

Cardiac Syndrome X; abnormal CRT; normal reference controls

Heart Rate Variability (HRV) OTHER

Holter monitor will be used to measure heart rate and rhythm for approximately 24 hours.

Cardiac Syndrome X; abnormal CRT; normal reference controls

RESPeRATE Breathing Trial OTHER

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.

Cardiac Syndrome X; abnormal CRT; normal reference controls

SPECT cardiac scan with 123I-mIBG and Myoview PROCEDURE

Single Photon Emission Computed Tomography (SPECT) cardiac scan with 123I-mIBG and Myoview will be used to measure cardiac sympathetic activity.

Cardiac Syndrome X; abnormal CRT; normal reference controls

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Macular dystrophy, corneal type 1

Interventions

technetium tc-99m tetrofosmin

Study Officials

• C. Noel Bairey Merz, M.D.

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

• Puja Mehta, M.D.

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: April 2, 2012
• Study Start: February 1, 2011
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)