NCT04123197

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
311

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

February 28, 2020

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

5.3 years

First QC Date

October 9, 2019

Last Update Submit

August 7, 2025

Conditions

Myocardial Infarction

Keywords

Cardiovascular diseaseDaily life stressorsMental stress-induced myocardial ischemia (MSI)

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular Events

    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.

    3 Years

Secondary Outcomes (4)

  • Myocardial Infarction or Cardiovascular Death

    3 Years

  • Cardiovascular Death

    3 Years

  • Total Mortality

    3 Years

  • Cardiovascular Events Excluding Heart Failure

    3 Years

Study Arms (1)

Young Participants with Prior MI

OTHER

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

Interventions

Stress ChallengeOTHER

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.

Young Participants with Prior MI

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Grady Health System

Atlanta, Georgia, 30322, United States

Location

The Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

  • 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.

    PMID: 35167312DERIVED

MeSH Terms

Conditions

Myocardial InfarctionCardiovascular Diseases

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Viola Vaccarino, MD, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 9, 2019

First Posted

October 10, 2019

Study Start

February 28, 2020

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

August 12, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(3)