- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04496687
International Spontaneous Coronary Artery Dissection (SCAD) "iSCAD" Registry
The International Spontaneous Coronary Artery Dissection "iSCAD" Registry (SCAD)
The aim of "iSCAD," the International Spontaneous Coronary Artery Dissection (SCAD) Registry, is to serve as an internationally collaborative, multicenter registry coordinated by an experienced and centralized coordinating center in an effort to increase the pace of participant recruitment, and thereby increase statistical power of studies related to SCAD.
The ultimate goal of iSCAD Registry is to facilitate the development of best practices and clinical guidelines for preventing SCAD or its recurrence. This observational study will be prospective and retrospective in its recruitment and will collect clinical information to better understand the natural history and prognosis for SCAD.
Study Overview
Status
Conditions
Detailed Description
Spontaneous Coronary Artery Dissection (SCAD) is an under-diagnosed cause of acute coronary syndrome (ACS), myocardial infarction (MI) and sudden cardiac arrest. The inner lining of the coronary artery splits and allows blood to seep into the adjacent layer, forming a blockage (hematoma), or the artery continues to tear, creating a flap of tissue that blocks blood flow in the artery.
SCAD strikes generally healthy, younger individuals (average age 42) who do not have traditional cardiac risk factors. Warning signs of SCAD encompass the full range of ACS and MI symptoms, from vague to classic. The cause of SCAD is currently unknown and the psychosocial impact of SCAD is traumatizing. The work of the iSCAD Registry will encompass the physical and psychosocial study of SCAD.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New South Wales
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Darlinghurst, New South Wales, Australia, NSW 2010
- Victor Chang Cardiac Research Institute
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California
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Los Angeles, California, United States, 90048
- Cedars Sinai
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Los Angeles, California, United States, 93003
- UCLA (University of California, Los Angeles)
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San Francisco, California, United States, 94115
- Kaiser Permanente Northern California
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado
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Connecticut
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Hartford, Connecticut, United States, 06106
- Hartford Hospital
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Florida
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Tampa, Florida, United States, 33602
- University of South Florida
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Georgia
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Atlanta, Georgia, United States, 30308
- Emory Healthcare System
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern Medicine
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Kentucky
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Lexington, Kentucky, United States, 40508
- University Of Kentucky
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Maryland
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Baltimore, Maryland, United States, 21224
- Johns Hopkins
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Massachusetts
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Boston, Massachusetts, United States, 02114-2696
- Massachusetts General Hospital
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Missouri
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Kansas City, Missouri, United States, 64111
- St. Luke's Mid America
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St Louis, Missouri, United States, 63110
- Washington University
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Dartmouth-Hitchcock
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Manchester, New Hampshire, United States, 03102
- Catholic Medical Center
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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New York, New York, United States, 10029-6574
- Mount Sinai
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North Carolina
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Charlotte, North Carolina, United States, 28204
- Atrium Health Sanger Heart and Vascular Institute
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Ohio
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Cleveland, Ohio, United States, 44106
- University Hospitals--Case Western
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73120
- Oklahoma Heart
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Oregon
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Portland, Oregon, United States, 97225
- Providence
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center
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Pittsburgh, Pennsylvania, United States, 15212
- Allegheny General Hospital, Allegheny Health Network
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, United States, 75390
- UT Southwestern
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Utah
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Murray, Utah, United States, 84107
- Intermountain
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Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia
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Fairfax, Virginia, United States, 22031
- Inova Heart & Vascular Institute
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Washington
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Seattle, Washington, United States, 98195
- University of Washington Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Participants with a new diagnosis of SCAD or a history of confirmed or suspected SCAD will be prospectively recruited from either:
- Inpatient wards of the enrolling medical centers during the acute presentation of SCAD, or
- Outpatient cardiovascular clinics of enrolling medical centers.
Participants must be:
- 18 years of age or older
- Diagnosis of SCAD or history of SCAD based on coronary angiography, either catheter-based or coronary CTA
- Suspected SCAD by coronary angiography
Exclusion Criteria:
- Coronary dissection in association with atherosclerosis or as a result of iatrogenic injury
- Inability to provide informed consent
- Inability to complete study-related patient questionnaires
- Inability to understand and complete patient questionnaires independently
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Descriptive Data
Time Frame: Continuous time frame following index event for an average of 3 years from study contact date
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Participant demographic, historical, clinical characteristics, and treatment data
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Continuous time frame following index event for an average of 3 years from study contact date
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Clinical Outcomes
Time Frame: Continuous time frame following index event for an average of 3 years from study contact date
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Prospectively collected long-term outcomes including recurrent myocardial infarction, hospitalization, heart failure, stroke or transient ischemic attack, arrhythmia, and all cause mortality
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Continuous time frame following index event for an average of 3 years from study contact date
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Psychosocial Outcomes
Time Frame: Continuous time frame following index event for an average of 3 years from study contact date
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Prospectively collected data on participant's mental health using validated questionnaires
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Continuous time frame following index event for an average of 3 years from study contact date
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Esther Kim, MD, Chair, Steering Committee
- Principal Investigator: Malissa Wood, MD, Member, Steering Committee
- Principal Investigator: Sahar Naderi, MD, Member, Steering Committee
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Heart Diseases
- Death
- Infarction
- Necrosis
- Myocardial Ischemia
- Ischemia
- Heart Arrest
- Death, Sudden
- Pathological Conditions, Signs and Symptoms
- Death, Sudden, Cardiac
- Myocardial Infarction
- Acute Coronary Syndrome
- Coronary Artery Dissection, Spontaneous
Other Study ID Numbers
- 20190308
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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