Clinical trial NCT02914483: Women's Heart Attack Research Program: Stress Ancillary Study
Official title: Women's Heart Attack Research Program: Stress Ancillary Study; Telephone-Based Stress Management for Women With Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myocardial Infarction
Keywords: Myocardial Infarction
Women
Stress Management
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-09-26
Enrollment: 200
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Perceived Stress Scale (PSS-10) scores
timeFrame: 6 months
Secondary outcomes:
measure: Short Form (SF-12) Score
timeFrame: 6 months
measure: Seattle Angina Questionnaire-7 Score (SAQ-7)
timeFrame: 6 months
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 6 months
measure: Sleep quality
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Gainesville
country: United States
facility: Univeristy of Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Baltimore
country: United States
facility: Johns Hopkins Medical Center
state: Maryland
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock
state: New Hampshire
city: Mineola
country: United States
facility: NYU Winthrop
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Bethlehem
country: United States
facility: St. Luke's University Health Network
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Austin
country: United States
facility: Seton Heart (Ascension) - University of Texas, Austin
state: Texas
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Calgary
country: Canada
facility: University of Calgary
Study officials:
affiliation: NYU Langone Medical Center
name: Harmony R Reynolds, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spruill TM, Reynolds HR, Dickson VV, Shallcross AJ, Visvanathan PD, Park C, Kalinowski J, Zhong H, Berger JS, Hochman JS, Fishman GI, Ogedegbe G. Telephone-based mindfulness training to reduce stress in women with myocardial infarction: Rationale and design of a multicenter randomized controlled trial. Am Heart J. 2018 Aug;202:61-67. doi: 10.1016/j.ahj.2018.03.028. Epub 2018 Apr 21.