Women's Heart Attack Research Program: Stress Ancillary Study

Description

The Women's HARP study is a multi-center study focusing on women with clinical presentation of myocardial infarction (MI). Women will complete stress questionnaires following presentation to the medical center with elevated cardiac enzymes and abnormal electrocardiograms (ECGs). 2 months following MI, participants will be screened for the Stress Ancillary Study and enrolled if an elevated level of perceived stress is reported. After completing baseline assessments, participants will be randomized to Enhanced Usual Care (EUC) or stress management for 8 weeks. Participants will be followed for 6 months.

Conditions

Myocardial Infarction

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Study Overview

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Study Details

Study overview

The Women's HARP study is a multi-center study focusing on women with clinical presentation of myocardial infarction (MI). Women will complete stress questionnaires following presentation to the medical center with elevated cardiac enzymes and abnormal electrocardiograms (ECGs). 2 months following MI, participants will be screened for the Stress Ancillary Study and enrolled if an elevated level of perceived stress is reported. After completing baseline assessments, participants will be randomized to Enhanced Usual Care (EUC) or stress management for 8 weeks. Participants will be followed for 6 months.

Women's Heart Attack Research Program: Stress Ancillary Study; Telephone-Based Stress Management for Women With Myocardial Infarction

Women's Heart Attack Research Program: Stress Ancillary Study

Condition
Myocardial Infarction
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Gainesville

Univeristy of Florida, Gainesville, Florida, United States, 32610

Atlanta

Emory University, Atlanta, Georgia, United States, 30322

Baltimore

Johns Hopkins Medical Center, Baltimore, Maryland, United States, 21287

Lebanon

Dartmouth-Hitchcock, Lebanon, New Hampshire, United States, 03766

Mineola

NYU Winthrop, Mineola, New York, United States, 11501

New York

NYU Langone Medical Center, New York, New York, United States, 10016

New York

Columbia University Medical Center, New York, New York, United States, 10032

Columbus

Ohio State University Medical Center, Columbus, Ohio, United States, 43210

Bethlehem

St. Luke's University Health Network, Bethlehem, Pennsylvania, United States, 18015

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Acute ischemic symptoms compatible with diagnosis of MI, such as chest pain or anginal equivalent symptoms at rest or new onset exertional anginal equivalent symptoms
  • * Objective evidence of MI (either or both of the following):
  • * Elevation of troponin to above the laboratory upper limit of normal
  • * ST segment elevation of ≥1mm on 2 contiguous ECG leads
  • * Willing to provide informed consent and comply with all aspects of the protocol
  • * Age ≥ 21 years
  • * Female sex
  • * PSS-4 score ≥6 at 2 month follow up visit after MI
  • * Alternate explanation for troponin elevation, such as hypertensive urgency, acute exacerbation of heart failure, chronic elevation due to kidney disease, pulmonary embolism, cardiac trauma.
  • * Moderately severe or severe depressive symptoms (PHQ-9 ≥ 15)
  • * Active suicidal ideation (PHQ-9 item #9 or otherwise reported during screening)
  • * History of or current diagnosis of psychosis (EHR review)
  • * Significant cognitive impairment (EHR review or evident during screening)
  • * Current participation in another behavioral clinical trial.

Ages Eligible for Study

21 Years to 99 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

NYU Langone Health,

Harmony R Reynolds, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Medical Center

Study Record Dates

2026-06-30