Spontaneous Coronary Artery Dissection
Conditions
Keywords
Pregnancy-related SCAD, Myocardial Infarction
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).
Interventions
None listed
Sponsors
Massachusetts General Hospital
Mayo Clinic
University Hospital, Clermont-Ferrand
University of British Columbia
University of Leicester
Vanderbilt University Medical Center
Katharine Sears Edwards
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First Major Adverse Cardiovascular Event (post-SCAD) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression | 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 | 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 | 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 | 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). |
Countries
United States
Outcome results
None listed