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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04123197
Recruitment Status : Enrolling by invitation
First Posted : October 10, 2019
Last Update Posted : November 4, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Viola Vaccarino MD/PhD, Emory University

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Other: Stress Challenge Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Mental Stress and Myocardial Ischemia After MI: Sex Differences, Mechanisms and Prognosis
Actual Study Start Date : February 28, 2020
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. Cardiovascular Death [ Time Frame: 3 Years ]
    The number of participants experiencing CV death in relation to MSI status (positive or negative).

  3. Total Mortality [ Time Frame: 3 Years ]
    The number of participants experiencing all-cause death in relation to MSI status (positive or negative).

  4. 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.



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.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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): NCT04123197


Locations
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United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Grady Health System
Atlanta, Georgia, United States, 30322
The Emory Clinic
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Viola Vaccarino, MD, PhD Emory University
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Responsible Party: Viola Vaccarino MD/PhD, Professor, Emory University
ClinicalTrials.gov Identifier: NCT04123197    
Other Study ID Numbers: IRB00113346
2R01HL109413-05A1 ( U.S. NIH Grant/Contract )
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Viola Vaccarino MD/PhD, Emory University:
Cardiovascular disease
Daily life stressors
Mental stress-induced myocardial ischemia (MSI)
Additional relevant MeSH terms:
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Myocardial Infarction
Myocardial Ischemia
Coronary Artery Disease
Infarction
Ischemia
Stress, Psychological
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Behavioral Symptoms