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

Angiographic and Psychosocial Evaluation of Peripartum vs. Non Peripartum Spontaneous Coronary Artery Dissection (SCAD): A Collaborative Study

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.

Study Overview

• Status: Completed
• Conditions: Spontaneous Coronary Artery Dissection

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
• Enrollment (Actual): 241

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First Major Adverse Cardiovascular Event (post-SCAD)	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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Patient Health Questionnaire (PHQ9) is a 9-item questionnaire that measures depression on a scale of 0-27 (where >20 is major depression).	At survey administration (post-SCAD), ranging from 6-months to 10 years post SCAD.
Anxiety	Generalized Anxiety Disorder (GAD-7) is a 7-item questionnaire that measures anxiety on a scale of 0-21 (where >14 is severe anxiety).	At survey administration (post-SCAD), ranging from 6-months to 10 years post SCAD.
Stress	Perceived Stress Scale (PSS) is a 10-item questionnaire that measures stress on a scale of 0-40 (where >26 is high perceived stress).	At survey administration (post-SCAD), ranging from 6-months to 10 years post SCAD.
Post-Traumatic Stress Disorder	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).	At survey administration (post-SCAD), ranging from 6-months to 10 years post SCAD.

Collaborators and Investigators

• Sponsor: Katharine Sears Edwards
• Collaborators: Massachusetts General Hospital; Mayo Clinic; University of British Columbia; Vanderbilt University Medical Center; University Hospital, Clermont-Ferrand; University of Leicester
• Investigators: Principal Investigator: Jennifer Ann Tremmel, MD, MS, Stanford University; Principal Investigator: Katharine S. Edwards, PhD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2017
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: December 13, 2017
• First Submitted That Met QC Criteria: December 28, 2017
• First Posted (Actual): January 5, 2018

Study Record Updates

• Last Update Posted (Actual): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 23, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Myocardial Infarction; Pregnancy-related SCAD
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Aneurysm; Vascular Diseases; Aneurysm, Dissecting; Coronary Vessel Anomalies
• Other Study ID Numbers: 40486

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No