Stress Challenge for Myocardial Ischemia

(MIMS3 Trial)

No longer recruiting at 2 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Must not be taking: Psychotropic meds

Disqualifiers: Unstable angina, Heart failure, Hypertension, Substance abuse, Severe psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how emotional stress affects heart health in men and women. Participants will undergo a stress test, known as the "Stress Challenge," to assess its impact on their heart condition, focusing on those who experienced a heart attack (myocardial infarction) within the last 8 months. The study includes one clinic visit, a week of home monitoring, and follow-up calls over 3 years. It seeks individuals who had a heart attack before age 60 and do not have certain other health issues, such as recent unstable angina or severe high blood pressure. As an unphased trial, this study offers a unique opportunity to contribute to understanding heart health after a heart attack.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but it mentions that anti-ischemic medications are typically paused before imaging studies. If you are on psychotropic medications (except anti-depressants), you may need to stop them as they are excluded if taken in the past month.

What prior data suggests that this stress challenge is safe for participants?

Research shows that stress tests are generally safe, but they can sometimes cause problems. One study found that about 16% of participants experienced reduced blood flow to the heart during the mental stress test. While most people handle the stress test well, some might feel heart-related symptoms.

Doctors have used stress tests for a long time to diagnose heart conditions, which gives them confidence in the tests' safety. However, it's important to pay attention to any discomfort during the test and inform healthcare professionals if it occurs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the stress challenge method for myocardial ischemia because it offers a new way to evaluate heart health in younger patients who have experienced a heart attack. Unlike traditional treatments like medication or surgery, this approach focuses on understanding the heart's response to stress, which could reveal critical insights into the progression of heart disease. By assessing myocardial ischemia through stress challenges, doctors might better predict risks and tailor treatments to prevent future cardiac events. This method could ultimately lead to more personalized care and improved outcomes for patients.

What evidence suggests that the Stress Challenge is effective for myocardial ischemia?

Research has shown that mental stress can reduce blood flow to the heart in people with coronary artery disease. This condition, known as mental stress-induced myocardial ischemia (MSIMI), is common in these patients and can lead to heart problems like heart attacks. Another study found that people who react strongly to stress might face a higher risk of heart issues over time. In this trial, young participants with a history of myocardial infarction (MI) will undergo a stress challenge to understand how emotional stress affects heart health, which could help improve treatment and prevention strategies. ^{4 6 7 8 9}

Who Is on the Research Team?

Viola Vaccarino, MD, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for men and women aged 60 or younger who had a heart attack within the last 8 months. It's not suitable for those with recent severe heart issues, high blood pressure on test day, current use of certain psychotropic drugs (except antidepressants), pregnant or breastfeeding women, people over 360 pounds or with a BMI of 40+, and individuals with other serious health problems.

Inclusion Criteria

I had a heart attack in the last 8 months.

I am 60 years old or younger and have had a heart attack.

Exclusion Criteria

It's unsafe for me to stop my heart disease medications before tests.

You have struggled with alcohol or drug abuse in the past year, or have a severe mental health condition besides major depression.

Pregnancy or breastfeeding (all women will receive a pregnancy test)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stress Challenge and Monitoring

Participants undergo a stress challenge to assess mental stress-induced myocardial ischemia (MSI) and are monitored at home for 1 week

1 week

1 clinic visit, 1 week of at-home monitoring

Follow-up

Participants are monitored for clinical events and outcomes related to MSI status through follow-up phone calls every 6 months

3 years

Follow-up phone calls every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Stress Challenge

Trial Overview The study investigates how emotional stress affects heart disease in different genders. Participants will have one clinic visit, monitor their condition at home for a week, and receive follow-up calls every six months over three years to track their heart health under stress.

How Is the Trial Designed?

Group I: Young Participants with Prior MI Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Significant advancements have been made in understanding coronary atherosclerosis and assessing the risk and burden of atherosclerotic disease over the past 40 years.

Stress testing is a key method for identifying abnormalities in blood flow to the heart during physical or drug-induced stress, helping to diagnose myocardial ischemia effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacologic manipulation of coronary vascular physiology for the evaluation of coronary artery disease. Farhad, H., Murthy, VL.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9628301/

Mental Stress-Induced Myocardial Ischemia - PMC The primary endpoint was cardiovascular death or initial or recurrent nonfatal myocardial infarction, and a secondary outcome also included ...

2. ahajournals.org ahajournals.org/doi/full/10.1161/JAHA.124.034683

Cardiovascular Reactivity to Mental Stress and Adverse ... The outcome was a composite of cardiovascular death, nonfatal myocardial infarction, and heart failure hospitalizations during follow‐up. A ...

3. jacc.org jacc.org/doi/10.1016/j.jacc.2012.11.037

Prevalence and Clinical Characteristics of Mental Stress– ... The goal of this study was to evaluate the prevalence and clinical characteristics of mental stress–induced myocardial ischemia.

4. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2021.683434/full

What Is the Clinical Impact of Stress CMR After ... In the present review, we will discuss the current state-of-the-art data on the prognostic value of stress CMR assessment of myocardial ischemia.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5373992/

The Mental Stress Ischemia Prognosis Study (MIPS) Mental stress-induced myocardial ischemia (MSIMI) has been shown to occur in a substantial proportion of patients with stable coronary artery disease (CAD) and ...

6. nhlbi.nih.gov nhlbi.nih.gov/news/2024/why-mental-stress-can-take-toll-heart

Why mental stress can take a toll on the heart - NHLBI - NIH During the mental stress test, 119 participants, 16% of the study sample, experienced myocardial ischemia. Those with the lowest heart rate ...

7. jacc.org jacc.org/doi/10.1016/j.jacc.2021.08.022

Stress Cardiac Magnetic Resonance Myocardial Perfusion ... This paper reviews the basics principles of stress CMR, the data supporting its clinical use, the added-value of myocardial blood flow ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2016919/

Safety and diagnostic accuracy of stress cardiac magnetic ... To determine the safety and diagnostic accuracy of adenosine‐stress cardiac magnetic resonance (CMR) perfusion imaging early after acute ST elevation myocardial ...

9. wolterskluwer.com wolterskluwer.com/en/news/stressinduced-effects-on-heart-blood-flow-differ-for-men-versus-women

Stress-induced effects on heart blood flow differ for men ... ... myocardial infarction (heart attack). The study targeted young and middle-aged adults (under age 61). All participants underwent conventional stress testing ...