Women's Heart Attack Research Program: Stress Ancillary Study

Completed · Not applicable

Conditions studied: Myocardial Infarction

In brief

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.

Key facts

Study ID

NCT02914483

Run by

NYU Langone Health

People needed

153

Starts

2017-01-19

Expected to finish

2020-10-24

Last updated by the study team

2026-04-06

Who can join

Age: 21 and older, up to 99. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Univeristy of Florida — Gainesville, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Johns Hopkins Medical Center — Baltimore, Maryland, United States
• Dartmouth-Hitchcock — Lebanon, New Hampshire, United States
• NYU Winthrop — Mineola, New York, United States
• NYU Langone Medical Center — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• St. Luke's University Health Network — Bethlehem, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Seton Heart (Ascension) - University of Texas, Austin — Austin, Texas, United States
• University of Alberta — Edmonton, Alberta, Canada
• University of Calgary — Calgary, Canada

Full record on ClinicalTrials.gov

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