An observational study in Spontaneous Coronary Artery Dissection, sponsored by Katharine Sears Edwards. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-25.
Sponsored by Katharine Sears Edwards · Observational
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Among 13 studies in Coronary Artery Dissection, Spontaneous with a site in United States — 8 open to participants now, 9 under way, none of them phase 3. Coronary Artery Dissection, Spontaneous · United States.
Among the 13 studies in Coronary Artery Dissection, Spontaneous with a site in United States, this one is the 7th largest by enrollment of the 10 observational ones that give a count, is the only one that started in 2017, is one of 10 observational ones, and was the 6th registered.
28 studies on the registry are indexed under Coronary Artery Dissection, Spontaneous; 18 are open to participants now.
Browse Coronary Artery Dissection, Spontaneous studies →8 of the 13 studies in Coronary Artery Dissection, Spontaneous with a site in United States are open now. Recruiting first, the newest first:
Mayo Clinic · Sites in United States
Ages 21–65
Vanderbilt University Medical Center · Sites in United States
Ages 18–100
Mayo Clinic · Sites in United States
Ages 18+ · Healthy volunteers
Mayo Clinic · Sites in United States
Ages 18+ · Women only · Healthy volunteers
Icahn School of Medicine at Mount Sinai · Sites in United States
Ages 18+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 13 Coronary Artery Dissection, Spontaneous studies recruiting now, 11 (85%) set no upper age limit and 1 (8%) stops at 75 or younger; 1 takes children under 18; 5 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
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13 studies; the count open now beside each. This study's row is marked.
First in 1995; this study’s year is marked. 1 started in 2017.
This study's enrollment of 241 is below the median of 457 across 18 observational studies indexed under Coronary Artery Dissection, Spontaneous.
Median enrollment 28 across the 3 interventional studies, 675 across the 10 observational. Of the 2 that completed or were terminated, 0 (0%) have results posted.
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None of the 13 has an industry lead sponsor. The 6 most frequent:
This is the only study on the registry with Katharine Sears Edwards as lead sponsor.
Katharine Sears Edwards has 1 study filed under Coronary Artery Dissection, Spontaneous — fewer than ten, so there is no comparison to draw.
5 of the studies in Coronary Artery Dissection, Spontaneous with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04496687SCAD AllianceInternational Spontaneous Coronary Artery Dissection (SCAD) "iSCAD" Registry | 2026-12-31 |
| NCT07529691Vanderbilt University Medical CenterSurvey on Physical Activity and Qualify of Life in Fibromuscular Dysplasia | 2027-04-30 |
| NCT05699200Mayo ClinicA Study to Analyze the Role of Sympathetic Nervous System in Spontaneous Coronary Artery Dissection | 2027-08 |
| NCT07526766Mayo ClinicA Study Of Exercise In Patients With Spontaneous Coronary Artery Dissection And Fibromuscular Dysplasia | 2027-08-30 |
| NCT07178509Mayo ClinicA Study of SCAD Using Stress Contrast Echocardiography | 2027-09 |
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Among the 13 studies in Coronary Artery Dissection, Spontaneous with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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).
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.
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Sites contacting patients and/or conducting the survey
Sites not contacting patients and/or conducting the survey
Exclusion Criteria
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)
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.
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.
Depression
Patient Health Questionnaire (PHQ9) is a 9-item questionnaire that measures depression on a scale of 0-27 (where \>20 is major depression).
Time frame: At survey administration (post-SCAD), ranging from 6-months to 10 years post SCAD.
Anxiety
Generalized Anxiety Disorder (GAD-7) is a 7-item questionnaire that measures anxiety on a scale of 0-21 (where \>14 is severe anxiety).
Time frame: At survey administration (post-SCAD), ranging from 6-months to 10 years post SCAD.
Stress
Perceived Stress Scale (PSS) is a 10-item questionnaire that measures stress on a scale of 0-40 (where \>26 is high perceived stress).
Time frame: At survey administration (post-SCAD), ranging from 6-months to 10 years post SCAD.
Post-Traumatic Stress Disorder
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).
Time frame: At survey administration (post-SCAD), ranging from 6-months to 10 years post SCAD.
Ran from Nov 2017 to primary completion in May 2019, 18 months.
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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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