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

Status: Active_not_recruiting
Location: See all (14) locations...
Intervention Type: Behavioral, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 21
Maximum Age: 99
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Cedars-Sinai Medical Center
Los Angeles
Florida
Univeristy of Florida
Gainesville
Georgia
Emory University
Atlanta
Maryland
Johns Hopkins Medical Center
Baltimore
New Hampshire
Dartmouth-Hitchcock
Lebanon
New York
NYU Winthrop
Mineola
Columbia University Medical Center
New York
NYU Langone Medical Center
New York
Ohio
Ohio State University Medical Center
Columbus
Pennsylvania
St. Luke's University Health Network
Bethlehem
University of Pittsburgh Medical Center
Pittsburgh
Texas
Seton Heart (Ascension) - University of Texas, Austin
Austin
Other Locations
Canada
University of Calgary
Calgary
University of Alberta
Edmonton
Time Frame
Start Date: 2016-08-01
Completion Date: 2026-06-30
Participants
Target number of participants: 200
Treatments
Other: Enhanced Usual Care (EUC)
Other: Stress Management
Related Therapeutic Areas
Sponsors
Leads: NYU Langone Health

This content was sourced from clinicaltrials.gov

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