RECRUITING

Women's Heart Attack Research Program: Stress Ancillary Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2016-08-01
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02914483

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.

Ages Eligible for Study:21 Years to 99 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Objective evidence of MI (either or both of the following):
  3. * Elevation of troponin to above the laboratory upper limit of normal
  4. * ST segment elevation of ≥1mm on 2 contiguous ECG leads
  5. * Willing to provide informed consent and comply with all aspects of the protocol
  6. * Age ≥ 21 years
  7. * Female sex
  8. * PSS-4 score ≥6 at 2 month follow up visit after MI
  1. * Alternate explanation for troponin elevation, such as hypertensive urgency, acute exacerbation of heart failure, chronic elevation due to kidney disease, pulmonary embolism, cardiac trauma.
  2. * Moderately severe or severe depressive symptoms (PHQ-9 ≥ 15)
  3. * Active suicidal ideation (PHQ-9 item #9 or otherwise reported during screening)
  4. * History of or current diagnosis of psychosis (EHR review)
  5. * Significant cognitive impairment (EHR review or evident during screening)
  6. * Current participation in another behavioral clinical trial.

Contacts and Locations

Study Contact

Tanya M Spruill, PhD
CONTACT
646-501-2619
Harmony R Reynolds, MD
CONTACT
646-501-0302
harmony.reynolds@nyumc.org

Principal Investigator

Harmony R Reynolds, MD
PRINCIPAL_INVESTIGATOR
NYU Langone Medical Center

Study Locations (Sites)

Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Univeristy of Florida
Gainesville, Florida, 32610
United States
Emory University
Atlanta, Georgia, 30322
United States
Johns Hopkins Medical Center
Baltimore, Maryland, 21287
United States
Dartmouth-Hitchcock
Lebanon, New Hampshire, 03766
United States
NYU Winthrop
Mineola, New York, 11501
United States
NYU Langone Medical Center
New York, New York, 10016
United States
Columbia University Medical Center
New York, New York, 10032
United States
Ohio State University Medical Center
Columbus, Ohio, 43210
United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
United States
Seton Heart (Ascension) - University of Texas, Austin
Austin, Texas, 78705
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-08-01
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2016-08-01
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • Myocardial Infarction
  • Women
  • Stress Management

Additional Relevant MeSH Terms

  • Myocardial Infarction