Women's Heart Attack Research Program: Stress Ancillary Study



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - 99
Updated:3/23/2019
Start Date:August 2016
End Date:April 2020
Contact:Tanya M Spruill, PhD
Phone:646-501-2619

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

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.

Women's HARP is a multi-center, observational study which enrolls women with MI who are
referred for cardiac catheterization. During the MI hospitalization, questionnaires will be
administered to assess psychosocial stress leading up to the event (MI). Participants will
also have the option to enroll in the HARP-Stress Ancillary Study and HARP-Platelet
Sub-Study. Two months following MI, participants may be screened for the Stress Ancillary
Study. Women with elevated perceived stress at screening will be enrolled. Patients will
complete baseline assessments (self-report questionnaires and 7 days of wrist actigraphy) and
then will be randomized to group-based stress management or to enhanced usual care (EUC).
Both study arms involve 8 weekly phone sessions delivered by trained facilitators. Following
intervention, participants in both study arms will repeat self-report questionnaires and 7
days of wrist actigraphy. Anticipate enrollment of approximately 200 women to meet target of
144 qualified women.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.
We found this trial at
12
sites
Baltimore, Maryland 21231
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Puja Kiran Mehta, MD
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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Austin, Texas 78705
Principal Investigator: Caitlin Giesler, MD
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Bethlehem, Pennsylvania
Principal Investigator: Dwithiya Thomas, MD
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Columbus, OH
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Gainesville, Florida 32610
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Lebanon, New Hampshire 03756
Principal Investigator: Bina Ahmed, MD
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Lebanon, NH
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259 1st Street
Mineola, New York 11501
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Mineola, NY
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New York, New York 10016
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New York, NY
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Pittsburgh, PA
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