- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04123197
Mental Stress and Myocardial Ischemia After MI: Sex Differences, Mechanisms and Prognosis (MIMS3)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Emory University Hospital
-
Atlanta, Georgia, United States, 30322
- The Emory Clinic
-
Atlanta, Georgia, United States, 30322
- Grady Health System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 Years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
3 Years
|
Cardiovascular Death
Time Frame: 3 Years
|
The number of participants experiencing CV death in relation to MSI status (positive or negative).
|
3 Years
|
Total Mortality
Time Frame: 3 Years
|
The number of participants experiencing all-cause death in relation to MSI status (positive or negative).
|
3 Years
|
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.
|
3 Years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Viola Vaccarino, MD, PhD, Emory University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00113346
- 2R01HL109413-05A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Myocardial Infarction
-
Azienda ULSS 5 PolesanaUniversity of PadovaUnknownMyocardial Infarction, Acute | ST Segment Elevation Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Italy
-
University Medical Centre LjubljanaCompletedCardiac Arrest | Postresuscitation Syndrome | Myocardial Infarction (ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction)Slovenia
-
Fundacio Privada Mon Clinic BarcelonaMiracor Medical SANot yet recruiting
-
Stiftung Institut fuer HerzinfarktforschungGlaxoSmithKline; University Hospital Muenster; Klinikum NürnbergCompletedMyocardial Infarction | ST-Elevation Myocardial Infarction | Non-ST-Elevation Myocardial InfarctionGermany
-
Population Health Research InstituteCanadian Institutes of Health Research (CIHR); Boston Scientific CorporationActive, not recruitingST Elevation Myocardial Infarction | Non ST Elevation Myocardial InfarctionCanada
-
Bispebjerg HospitalOdense University Hospital; Zealand University Hospital; Hvidovre University... and other collaboratorsRecruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Denmark
-
Barts & The London NHS TrustUniversity College, London; Queen Mary University of LondonCompletedAcute Myocardial InfarctionSwitzerland, Denmark, United Kingdom
-
University of LeedsUniversity College, LondonCompletedST-elevation Myocardial Infarction | Non ST-elevation Myocardial Infarction
-
Karolinska InstitutetUppsala University; The Swedish Research CouncilActive, not recruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial InfarctionSweden
-
Oslo University HospitalVestre Viken Hospital Trust; University of Oslo; University Hospital of North... and other collaboratorsActive, not recruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial InfarctionNorway
Clinical Trials on Stress Challenge
-
Lund UniversityFood for Health Science Centre, Lund UniversityCompleted
-
Joslin Diabetes CenterImmusanT, Inc.CompletedType 1 Diabetes | Celiac DiseaseUnited States
-
Hospital Mutua de TerrassaCompletedCeliac Disease | Non-celiac Gluten Sensitivity
-
Emory UniversityCenters for Disease Control and PreventionCompleted
-
Mahidol UniversityCompletedFood (Shrimp) AllergyThailand
-
Virginia Commonwealth UniversityCompleted
-
Hospices Civils de LyonRecruitingAcute Kidney InjuryFrance
-
McMaster UniversitySt. Joseph's Healthcare HamiltonUnknown
-
University of PalermoAurelio SeiditaRecruiting
-
American UniversityCompletedSmoking CessationUnited States