Clinical Trial â Women's Heart Attack Research Program: Stress Ancillary Study (HARP) â 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 |
* The Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.