Myocardial Infarction
Conditions
Keywords
Cardiovascular disease, Daily life stressors, Mental stress-induced myocardial ischemia (MSI)
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, 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.
Interventions
OTHERStress Challenge
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.
Sponsors
Emory University
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Events | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial Infarction or Cardiovascular Death | 3 Years | The number of participants experiencing myocardial infarction or CV death in relation to MSI status (positive or negative). |
| Cardiovascular Death | 3 Years | The number of participants with a CV death in relation to MSI status (positive or negative). |
| Total Mortality | 3 Years | All-cause death in relation to MSI status (positive or negative). |
| Cardiovascular Events Excluding Heart Failure | 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) was examined. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORViola Vaccarino, MD, PhD
Emory University
Participant flow
Recruitment details
Participants were recruited from Grady and Emory Healthcare System in Atlanta, Georgia, USA. Participant enrollment began February 28, 2020, and all follow-up was complete by May 31, 2025.
Pre-assignment details
Participants were followed for 3 years with phone calls and review of medical records and the National Death Index, to assess the occurrence of outcome events (a composite endpoint or recurrent MI, unstable angina, hospitalization for decompensated heart failure, and cardiovascular death).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 306 Participants |
| Age, Continuous | 51 years STANDARD_DEVIATION 7 |
| Body Mass Index (BMI) | 31 Kg/m^2 STANDARD_DEVIATION 6 |
| Education >12 years | 207 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 294 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Income < $25,0000 | 74 Participants |
| Left-ventricular ejection fraction (%) | 50 percentage of blood pumped STANDARD_DEVIATION 12 |
| Participants who have a history of smoking | 124 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 14 Participants |
| Race (NIH/OMB) Black or African American | 164 Participants |
| Race (NIH/OMB) More than one race | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 118 Participants |
| Region of Enrollment United States | 306 participants |
| Sex: Female, Male Female | 176 Participants |
| Sex: Female, Male Male | 130 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 306 |
| other Total, other adverse events | 0 / 306 |
| serious Total, serious adverse events | 0 / 306 |
Outcome results
None listed