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Mental Stress and Myocardial Ischemia After MI: Sex Differences, Mechanisms and Prognosis (MIMS3)

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ClinicalTrials.gov Identifier: NCT04123197
Recruitment Status : Not yet recruiting
First Posted : October 10, 2019
Last Update Posted : November 28, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Viola Vaccarino MD/PhD, Emory University

Tracking Information
First Submitted Date  ICMJE October 9, 2019
First Posted Date  ICMJE October 10, 2019
Last Update Posted Date November 28, 2019
Estimated Study Start Date  ICMJE December 2019
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2019)
Cardiovascular Events [ Time Frame: 3 Years ]
The main outcome will be a composite endpoint of recurrent MI, unstable angina, hospitalization for decompensated heart failure, and cardiovascular (CV) death. A mental stress-induced myocardial ischemia (MSI) status of positive or negative will be the main predictor in regression models.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04123197 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2019)
  • Myocardial Infarction or Cardiovascular Death [ Time Frame: 3 Years ]
    The number of participants experiencing myocardial infarction or CV death in relation to MSI status (positive or negative).
  • Cardiovascular Death [ Time Frame: 3 Years ]
    The number of participants experiencing CV death in relation to MSI status (positive or negative).
  • Total Mortality [ Time Frame: 3 Years ]
    The number of participants experiencing all-cause death in relation to MSI status (positive or negative).
  • Cardiovascular Events Excluding Heart Failure [ Time Frame: 3 Years ]
    This is a composite endpoint of recurrent MI, unstable angina, or CV death where the number of participants experiencing this endpoint in relation to MSI status (positive or negative) will be examined.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mental Stress and Myocardial Ischemia After MI: Sex Differences, Mechanisms and Prognosis
Official Title  ICMJE Mental Stress and Myocardial Ischemia After MI: Sex Differences, Mechanisms and Prognosis
Brief Summary The purpose of this study is to look at the link between emotional stress and heart disease in men and women. Taking part in this study involves one clinic visit, one week of at home monitoring, and follow up phone calls every 6 months for 3 years.
Detailed Description

In the U.S. and globally, coronary heart disease (CHD) is the number one killer of women. Despite scientific advances, it is unclear whether the pathophysiology of CHD differs between women and men. The study of CHD in women has historically been centered on older women, however, women with early onset CHD are informative for the study of early risk factors and pathophysiology. Furthermore, young women with a myocardial infarction (MI) have emerged as a group in need of special study as this group has higher mortality compared with men of similar age despite less severe disease. These disparities remain unexplained and suggest sex differences in the pathophysiology, risk factors and prognostic factors of acute MI.

The psychosocial sphere is a largely neglected area for CHD prevention in women. Social and emotional exposures mostly beginning early in life (depression, early life adversities, poverty and posttraumatic stress symptoms) are more common in younger women with MI compared with men and community controls. In addition to being more prevalent, it is possible that emotional stress is a stronger risk factor in young women than other groups. A significant challenge, however, is to measure stress in a valid way.

Building on previous work, the current project will clarify sex differences in pathways of risk linking emotional stress to mental stress-induced myocardial ischemia (MSI) and cardiovascular outcomes in young post-MI patients. Within 8 months of MI, 300 patients ≤60 years of age (at the time of the MI), 50% women, will be tested in the lab with a stress challenge to asses MSI using an established protocol with myocardial perfusion imaging. Participants will be monitored at home for 1 week, and then followed for clinical events for 3 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Myocardial Infarction
Intervention  ICMJE Other: Stress Challenge
The stress challenge will assess how different parts of the body react to stress. Participants will be given no specific details about the contents of the test before administration.
Study Arms  ICMJE Young Participants with Prior MI
Participants aged 60 or less who experienced a MI within the last 8 months will undergo a stress challenge to assess MSI and will then be followed for 3 years.
Intervention: Other: Stress Challenge
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 9, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • History of documented MI within the past 8 months
  • Age ≤60 at the time of MI

Exclusion Criteria:

  • History of unstable angina, MI, or decompensated heart failure in past month
  • Patients deemed to be unsafe to hold anti-ischemic medications before testing (it is standard protocol to hold these meds before imaging studies)
  • Systolic blood pressure (SBP) >170 mm Hg or diastolic blood pressure (DBP) >100 mm Hg on the day of the test
  • Alcohol or substance abuse (past year), or severe psychiatric disorder other than major depression
  • Other serious medical disorder that may interfere with the study results
  • Postmenopausal hormone therapy (past 3 months)
  • Current psychotropic medications (past month) except anti-depressants
  • Pregnancy or breast feeding (all women will receive a pregnancy test)
  • Severe aortic stenosis
  • Weight ≥ 350 pounds and/or body mass index (BMI) of 40 or greater (weIght limit of the SPECT imaging table)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lucy Shallenberger 404-712-8267 lshalle@emory.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04123197
Other Study ID Numbers  ICMJE IRB00113346
2R01HL109413-05A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Viola Vaccarino MD/PhD, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Viola Vaccarino, MD, PhD Emory University
PRS Account Emory University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP