Angiographic and Psychosocial Evaluation of Peripartum vs. Non: SCAD (SCAD)
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|ClinicalTrials.gov Identifier: NCT03390998|
Recruitment Status : Enrolling by invitation
First Posted : January 5, 2018
Last Update Posted : August 31, 2018
|Condition or disease|
|Spontaneous Coronary Artery Dissection|
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|
|Estimated Enrollment :||600 participants|
|Official Title:||Angiographic and Psychosocial Evaluation of Peripartum vs. Non Peripartum Spontaneous Coronary Artery Dissection (SCAD): A Collaborative Study|
|Actual Study Start Date :||November 28, 2017|
|Estimated Primary Completion Date :||May 31, 2019|
|Estimated Study Completion Date :||August 31, 2019|
Female patients who experienced any SCAD event that occurred during pregnancy or up to 1 year post-delivery
Female patients who experienced any SCAD with event onset outside of the pregnancy period
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03390998
|United States, California|
|Stanford University Medical Center|
|Palo Alto, California, United States, 94305|
|Principal Investigator:||Jennifer Ann Tremmel, MD, MS||Stanford University|
|Principal Investigator:||Katharine S. Edwards, PhD||Stanford University|