Stress Challenge for Myocardial Ischemia

(MIMS3 Trial)

Recruiting at 2 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

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

Compensation: Varies

Number of Visits: 7

311 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Stress Challenge for myocardial ischemia?

Research shows that mental stress can trigger myocardial ischemia (reduced blood flow to the heart) in patients with coronary artery disease, similar to how physical exercise does. Managing stress effectively could potentially help in reducing the risk of future heart problems in these patients. ^{1 2 3 4 5}

Is the Stress Challenge for Myocardial Ischemia safe for humans?

The studies reviewed indicate that mental stress can induce myocardial ischemia (reduced blood flow to the heart) in patients with coronary artery disease, similar to exercise stress tests. However, the safety of mental stress testing itself is not directly addressed, and it appears to be used as a diagnostic tool rather than a treatment. ^{3 6 7 8 9}

How does the stress challenge treatment for myocardial ischemia differ from other treatments?

The stress challenge treatment for myocardial ischemia is unique because it uses mental stress tasks, like public speaking, to induce ischemia, which can occur at lower heart rates compared to exercise-induced ischemia. This approach highlights the role of emotional stress in triggering silent ischemic events, offering a novel way to study and potentially manage myocardial ischemia in patients with coronary artery disease. ^{2 10 11 12 13}

Research Team

Viola Vaccarino, MD, PhD

Principal Investigator

Emory University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Stress management and exercise training in cardiac patients with myocardial ischemia. Effects on prognosis and evaluation of mechanisms. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Mental stress and the induction of silent myocardial ischemia in patients with coronary artery disease. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Meta-analysis of mental stress-induced myocardial ischemia and subsequent cardiac events in patients with coronary artery disease. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Sex differences in brain activation patterns with mental stress in patients with coronary artery disease. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The exercise test as a guide to management and prognosis. [2007]

6. United States pubmed.ncbi.nlm.nih.gov

Comparison of myocardial ischemia during intense mental stress using flight simulation in airline pilots with coronary artery disease to that produced with conventional mental and treadmill exercise stress testing. [2016]

7. England pubmed.ncbi.nlm.nih.gov

Association Between Symptoms of Chronic Psychological Distress and Myocardial Ischemia Induced by Mental Stress in Patients With Coronary Artery Disease. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Mental stress as a provocative test in patients with various clinical syndromes of coronary heart disease. [2004]

9. India pubmed.ncbi.nlm.nih.gov

Induction of myocardial ischaemia by mental stress in coronary heart disease. [2007]

10. United States pubmed.ncbi.nlm.nih.gov

Electrocardiographic Comparison of Dobutamine and BRUCE Cardiac Stress Testing With High Resolution Mapping in Experimental Models. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Mental stress--induced myocardial ischemia and cardiac events. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Pharmacologic manipulation of coronary vascular physiology for the evaluation of coronary artery disease. [2015]

13. United States pubmed.ncbi.nlm.nih.gov

Mental stress-induced ischemia in the laboratory and ambulatory ischemia during daily life. Association and hemodynamic features. [2019]