Clinical trial NCT03390998: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spontaneous Coronary Artery Dissection
Keywords: Pregnancy-related SCAD
Myocardial Infarction
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: Mayo Clinic
name: University Hospital, Clermont-Ferrand
name: University of British Columbia
name: University of Leicester
name: Vanderbilt University Medical Center
First posted: 2018-01-05
Enrollment: 241
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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).

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

Primary outcomes:
measure: First Major Adverse Cardiovascular Event (post-SCAD)
timeFrame: 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 outcomes:
measure: Depression
timeFrame: At survey administration (post-SCAD), ranging from 6-months to 10 years post SCAD.
measure: Anxiety
timeFrame: At survey administration (post-SCAD), ranging from 6-months to 10 years post SCAD.
measure: Stress
timeFrame: At survey administration (post-SCAD), ranging from 6-months to 10 years post SCAD.
measure: Post-Traumatic Stress Disorder
timeFrame: At survey administration (post-SCAD), ranging from 6-months to 10 years post SCAD.
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
affiliation: Stanford University
name: Jennifer Ann Tremmel, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Katharine S. Edwards, PhD
role: PRINCIPAL_INVESTIGATOR
References: