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

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

Tracking Information

• First Submitted Date: October 9, 2019
• First Posted Date: October 10, 2019
• Last Update Posted Date: November 28, 2019
• Estimated Study Start Date: December 2019
• Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: Complete list of historical versions of study NCT04123197 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Mental Stress and Myocardial Ischemia After MI: Sex Differences, Mechanisms and Prognosis
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Myocardial Infarction

Intervention

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

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

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: October 9, 2019): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2024
• Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Lucy Shallenberger; 404-712-8267; lshalle@emory.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04123197
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Viola Vaccarino MD/PhD, Emory University
• Study Sponsor: Emory University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Viola Vaccarino, MD, PhD; Emory University

• PRS Account: Emory University
• Verification Date: November 2019