Angiographic and Psychosocial Evaluation of Peripartum vs. Non: SCAD
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/2/2018 |
| Start Date: | November 28, 2017 |
| End Date: | August 31, 2019 |
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.
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.
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).
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).
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
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