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

NCT ID: NCT04123197

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 311 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-28
• Study Completion Date: 2025-05-31

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.

Conditions

Myocardial Infarction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Stress Challenge

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Viola Vaccarino

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Viola Vaccarino, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Hospital

Atlanta, Georgia, United States

Grady Health System

Atlanta, Georgia, United States

The Emory Clinic

Atlanta, Georgia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35167312 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

2R01HL109413-05A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00113346

Identifier Type: -

Identifier Source: org_study_id