Angiographic and Psychosocial Evaluation of Peripartum vs. Non: SCAD — SCAD  

Spontaneous Coronary Artery Dissection Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Spontaneous Coronary Artery Dissection

• NCT number: NCT03390998
• Study type: Observational
• Source: Stanford University
• Status: Completed
• Start date: November 28, 2017
• Completion date: May 31, 2019