Myocardial InfarctionMIMS3NCT04123197
Mental Stress and Myocardial Ischemia After MI: Sex Differences, Mechanisms and Prognosis
A study testing Stress Challenge in people with Myocardial Infarction, run by Emory University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Stress Challenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Feb 2020to 31 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- History of documented MI within the past 8 months
- Age ≤60 at the time of MI
Who cannot join
- 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)
Show all 10Show fewer
- 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University Hospital
Atlanta, Georgia, 30322
Grady Health System
Atlanta, Georgia, 30322
The Emory Clinic
Atlanta, Georgia, 30322
About this study
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.
Read the 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, emotional stress may be a stronger risk factor in young women than in other groups. A significant challenge, however, is to measure stress validly.
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 assess 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
- Being tested
- Stress Challenge
- Keywords
- Cardiovascular disease, Daily life stressors, Mental stress-induced myocardial ischemia (MSI)
- Medical subject headings
- Myocardial Infarction, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress ChallengeOther
The stress challenge assessed how different parts of the body react to stress. Participants were given no specific details about the test content before administration.
| Study group | Role | What they receive |
|---|---|---|
| Young Participants with Prior MI | Other | Participants aged 60 or less who experienced a MI within the last 8 months underwent a stress challenge to assess MSI and were followed for 3 years. Receives: Other: Stress Challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Events
The main outcome was 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 was used as the main predictor in regression models.
Measured: 3 Years
Secondary outcomes (4)
Myocardial Infarction or Cardiovascular Death
The number of participants experiencing myocardial infarction or CV death in relation to MSI status (positive or negative).
Measured: 3 Years
Cardiovascular Death
The number of participants with a CV death in relation to MSI status (positive or negative).
Measured: 3 Years
Total Mortality
All-cause death in relation to MSI status (positive or negative).
Measured: 3 Years
Cardiovascular Events Excluding Heart Failure
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) was examined.
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start28 Feb 2020
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Viola Vaccarino, Emory University
- Investigators
- Viola Vaccarino, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123197
- Sponsor's protocol ID
- IRB00113346
- Other IDs
- 2R01HL109413-05A1
- Acronym
- MIMS3
- Status last verified
- Jun 2026
- First submitted
- 9 Oct 2019
- Last updated
- 24 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35167312
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Stress and Myocardial Ischemia After MI: Sex Differences, Mechanisms and Prognosis
- ClinicalTrials.gov ID
- NCT04123197
- Acronym / sponsor ID
- MIMS3 / IRB00113346
- Conditions
- Myocardial Infarction
- Keywords
- Cardiovascular disease, Daily life stressors, Mental stress-induced myocardial ischemia (MSI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Posted 24 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, emotional stress may be a stronger risk factor in young women than in other groups. A significant challenge, however, is to measure stress validly.
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 assess 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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young Participants with Prior MI | Other | Other: Stress ChallengeParticipants aged 60 or less who experienced a MI within the last 8 months underwent a stress challenge to assess MSI and were followed for 3 years. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- History of documented MI within the past 8 months
- Age ≤60 at the time of MI
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress ChallengeThe stress challenge assessed how different parts of the body react to stress. Participants were given no specific details about the test content before administration. | Other | Young Participants with Prior MI |
Primary outcome
Cardiovascular Events
Time frame: 3 Years
The main outcome was 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 was used as the main predictor in regression models.
4 secondary outcomes
Myocardial Infarction or Cardiovascular Death
Time frame: 3 Years
Cardiovascular Death
Time frame: 3 Years
Total Mortality
Time frame: 3 Years
Cardiovascular Events Excluding Heart Failure
Time frame: 3 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35167312Shah 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viola Vaccarino, MD, PhD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Challenge in people with Myocardial Infarction, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Events (time frame: 3 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04123197, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.