Clinical trial NCT04123197: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myocardial Infarction
Keywords: Cardiovascular disease
Daily life stressors
Mental stress-induced myocardial ischemia (MSI)
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-10-10
Enrollment: 311
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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, 310 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.

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 the 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) \>180 mm Hg or diastolic blood pressure (DBP) \>110 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 disorders that may interfere with the study results
* Postmenopausal hormone therapy (past 3 months)
* Current psychotropic medications (past month) except anti-depressants
* Pregnancy or breastfeeding (all women will receive a pregnancy test)
* Severe aortic stenosis
* Weight ≥ 360 pounds and/or body mass index (BMI) of 40 or greater (weight limit of the SPECT imaging table)

Primary outcomes:
measure: Cardiovascular Events
timeFrame: 3 Years
Secondary outcomes:
measure: Myocardial Infarction or Cardiovascular Death
timeFrame: 3 Years
measure: Cardiovascular Death
timeFrame: 3 Years
measure: Total Mortality
timeFrame: 3 Years
measure: Cardiovascular Events Excluding Heart Failure
timeFrame: 3 Years
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
Study officials:
affiliation: Emory University
name: Viola Vaccarino, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shah AJ, Weeks V, Lampert R, Bremner JD, Kutner M, Raggi P, Sun YV, Lewis TT, Levantsevych O, Kim YJ, Hammadah M, Alkhoder A, Wittbrodt M, Pearce BD, Ward L, Sheps D, Quyyumi AA, Vaccarino V. Early Life Trauma Is Associated With Increased Microvolt T-Wave Alternans During Mental Stress Challenge: A Substudy of Mental Stress Ischemia: Prognosis and Genetic Influences. J Am Heart Assoc. 2022 Mar;11(5):e021582. doi: 10.1161/JAHA.121.021582. Epub 2022 Feb 15.