Clinical Trial – Women's Heart Attack Research Program: Stress Ancillary Study (HARP) – Heart Attack

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.

Study Type  : Interventional  (Clinical Trial)
Estimated Enrollment  : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Women’s Heart Attack Research Program: Stress Ancillary Study; Telephone-Based Stress Management for Women With Myocardial Infarction
Study Start Date  : August 2016
Estimated Primary Completion Date  : April 2020
Estimated Study Completion Date  : April 2020
Contacts
Contact: Tanya M Spruill, PhD 646-501-2619
Contact: Harmony R Reynolds, MD 646-501-0302 harmony.reynolds@nyumc.org
Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: C Noel Bairey Merz, MD
United States, Florida
Univeristy of Florida Active, not recruiting
Gainesville, Florida, United States, 32610
United States, Maryland
Johns Hopkins Medical Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Jeffrey C Trost, MD
United States, New York
NYU Winthrop Recruiting
Mineola, New York, United States, 11501
Contact: Kevin Marzo, MD
NYU Langone Medical Center Recruiting
New York, New York, United States, 10016
Columbia University Medical Center Active, not recruiting
New York, New York, United States, 10032
United States, Ohio
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Laxmi Mehta, MD
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Catalin Toma, MD
ClinicalTrials.gov Identifier: NCT02914483
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