Angiographic and Psychosocial Evaluation of Peripartum vs. Non: SCAD (SCAD)

• ClinicalTrials.gov Identifier: NCT03390998
• Recruitment Status: Completed
• First Posted: January 5, 2018
• Last Update Posted: September 25, 2019
• Sponsor: Katharine Sears Edwards
• Collaborators: Massachusetts General Hospital; Mayo Clinic; University Hospital, Clermont-Ferrand; University of British Columbia; University of Leicester; Vanderbilt University Medical Center
• Information provided by (Responsible Party): Katharine Sears Edwards, Stanford University

Tracking Information

• First Submitted Date: December 13, 2017
• First Posted Date: January 5, 2018
• Last Update Posted Date: September 25, 2019
• Actual Study Start Date: November 28, 2017
• Actual Primary Completion Date: May 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 28, 2017)

First Major Adverse Cardiovascular Event (post-SCAD) [ Time Frame: First SCAD event represents t=0. Time (in days) from t=0 until the first occurrence of any of the above, for up to 6-months after t=0. ]

The time from the first SCAD event until the first occurrence of (1) myocardial infarction, (2) re-vascularization, (3) stroke, or (4) death due to cardiovascular cause.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 28, 2017)

• Depression [ Time Frame: At survey administration (post-SCAD), ranging from 6-months to 10 years post SCAD. ]
  Patient Health Questionnaire (PHQ9) is a 9-item questionnaire that measures depression on a scale of 0-27 (where >20 is major depression).
• Anxiety [ Time Frame: At survey administration (post-SCAD), ranging from 6-months to 10 years post SCAD. ]
  Generalized Anxiety Disorder (GAD-7) is a 7-item questionnaire that measures anxiety on a scale of 0-21 (where >14 is severe anxiety).
• Stress [ Time Frame: At survey administration (post-SCAD), ranging from 6-months to 10 years post SCAD. ]
  Perceived Stress Scale (PSS) is a 10-item questionnaire that measures stress on a scale of 0-40 (where >26 is high perceived stress).
• Post-Traumatic Stress Disorder [ Time Frame: At survey administration (post-SCAD), ranging from 6-months to 10 years post SCAD. ]
  PTSD CheckList (PCL-5) is a 20-item questionnaire that assesses the presence and severity of PTSD symptoms on a scale of 0-80 (where >32 suggests the patients needs further assessment to confirm a diagnosis of PTSD).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Angiographic and Psychosocial Evaluation of Peripartum vs. Non: SCAD
• Official Title: Angiographic and Psychosocial Evaluation of Peripartum vs. Non Peripartum Spontaneous Coronary Artery Dissection (SCAD): A Collaborative Study
• Brief Summary: This multi-site international clinical research project is a collaboration between investigators from multiple institutions in the USA, Canada, and Europe. Approximately 7 to 11 sites will participate and provide data for analysis. Clinical operations (for data collection and analysis) across sites will be managed by Stanford. The study purpose is to determine differences in clinical and imaging presentation, in-hospital management and prognosis in peripartum and non-peripartum SCAD patients.

Detailed Description

There is a reason to believe that female sex hormone fluctuations during the peripartum period are linked with the occurrence of SCAD, and may be associated with a distinctive clinical presentation. In addition, symptoms of psychological distress may be linked to the development of SCAD and post-event distress is higher in SCAD patients than in those with coronary artery disease (CAD).

The primary objective is to determine differences in clinical and imaging presentation, in-hospital management and prognosis in peri-partum and non-peri-partum SCAD patients. At the methodological level, the purpose is to apply a systematic image analysis protocol for classifying SCAD lesions and to pool data to achieve adequate statistical power.

The secondary objective is to gather more information about psychological and psychosocial factors in SCAD patients. Specifically, to assess pre-event stress and psychological diagnoses and determine differences in post-event distress between peripartum and non-peripartum SCAD.

It is expected that these aims will result in two important outcomes. First, implementation of a systematic image analysis protocol for SCAD data will lead to improved reliability and, we expect, the detection of clinically meaningful differences between peripartum and non-peripartum SCAD. These differences may align with potential causal mechanisms for further study to ultimately better understand SCAD and develop treatment(s). Second, by characterizing the psychological distress experienced by SCAD patients, and differences between patients who experienced peripartum vs. non-peripartum SCAD, psychosocial risk factors may be identified and psychosocial interventions can be tailored to meet the needs of this unique patient population.

This is an observational study using cross-sectional design. There are two main components: a retrospective collection of medical history pertaining to SCAD event and prospective questionnaires. Sites may elect not to contact patients and not collect the prospective questionnaire.

Clinical variables will include demographic data, cardiac risk factors, medications and details of presentation (including peak troponin, left ventricular ejection fraction (LVEF), and days to discharge), as well as follow-up data, including recurrent events, and symptoms of depression, anxiety, stress, and PTSD.

Clinical data will be obtained by study collaborators and entered into a secure database maintained on Stanford systems. De-identified imaging data will be uploaded by collaborators. Imaging data will be analyzed by two independent readers (selected from participating institutions).

• Study Type: Observational
• Study Design: Observational Model: Other; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Participants with pregnancy-related and non pregnancy-related SCAD will be recruited from the population of SCAD patients known to an international collaborative of investigators. We expect to enroll approximately 400 patients, 100 of whom have experienced peripartum SCAD. For each enrolled participant with peripartum SCAD, we will enroll 3 patients with non-peripartum SCAD who are the closest match on age at SCAD event and country.
• Condition: Spontaneous Coronary Artery Dissection
• Intervention: Not Provided

Study Groups/Cohorts

• Peripartum SCAD
  Female patients who experienced any SCAD event that occurred during pregnancy or up to 1 year post-delivery
• Non-peripartum SCAD
  Female patients who experienced any SCAD with event onset outside of the pregnancy period

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 23, 2019): 241
• Original Estimated Enrollment (submitted: December 28, 2017): 600
• Actual Study Completion Date: May 31, 2019
• Actual Primary Completion Date: May 31, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

Sites contacting patients and/or conducting the survey

• Female adults 18 years of age and older
• Voluntary participation
• Patients with a known or suspected diagnosis of SCAD
• Ability to read in English
• Ability to access online consent and questionnaire portal

Sites not contacting patients and/or conducting the survey

• Female adults 18 years of age and older
• Patients with a known or suspected diagnosis of SCAD

Exclusion Criteria

- Not fulfilling inclusion criteria

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Only women will be studied as the primary question relates to pregnancy-related SCAD

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03390998
• Other Study ID Numbers: 40486
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Katharine Sears Edwards, Stanford University
• Original Responsible Party: Same as current
• Current Study Sponsor: Katharine Sears Edwards
• Original Study Sponsor: Same as current

Collaborators

• Massachusetts General Hospital
• Mayo Clinic
• University Hospital, Clermont-Ferrand
• University of British Columbia
• University of Leicester
• Vanderbilt University Medical Center

Investigators

• Principal Investigator: Jennifer Ann Tremmel, MD, MS; Stanford University
• Principal Investigator: Katharine S. Edwards, PhD; Stanford University

• PRS Account: Stanford University
• Verification Date: September 2019