International Spontaneous Coronary Artery Dissection (SCAD) "iSCAD" Registry
- Conditions
- Spontaneous Coronary Artery Dissection
- Registration Number
- NCT04496687
- Lead Sponsor
- SCAD Alliance
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Descriptive Data Continuous time frame following index event for an average of 3 years from study contact date Participant demographic, historical, clinical characteristics, and treatment data
Clinical Outcomes Continuous time frame following index event for an average of 3 years from study contact date Prospectively collected long-term outcomes including recurrent myocardial infarction, hospitalization, heart failure, stroke or transient ischemic attack, arrhythmia, and all cause mortality
Psychosocial Outcomes Continuous time frame following index event for an average of 3 years from study contact date Prospectively collected data on participant's mental health using validated questionnaires
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (31)
University Hospitals--Case Western
🇺🇸Cleveland, Ohio, United States
Cedars Sinai
🇺🇸Los Angeles, California, United States
UCLA (University of California, Los Angeles)
🇺🇸Los Angeles, California, United States
Kaiser Permanente Northern California
🇺🇸San Francisco, California, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Emory Healthcare System
🇺🇸Atlanta, Georgia, United States
Northwestern Medicine
🇺🇸Chicago, Illinois, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
St. Luke's Mid America
🇺🇸Kansas City, Missouri, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Dartmouth-Hitchcock
🇺🇸Lebanon, New Hampshire, United States
Catholic Medical Center
🇺🇸Manchester, New Hampshire, United States
Mount Sinai
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Atrium Health Sanger Heart and Vascular Institute
🇺🇸Charlotte, North Carolina, United States
Oklahoma Heart
🇺🇸Oklahoma City, Oklahoma, United States
Providence
🇺🇸Portland, Oregon, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Allegheny General Hospital, Allegheny Health Network
🇺🇸Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
UT Southwestern
🇺🇸Dallas, Texas, United States
Intermountain
🇺🇸Murray, Utah, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Inova Heart & Vascular Institute
🇺🇸Fairfax, Virginia, United States
University of Washington Medicine
🇺🇸Seattle, Washington, United States
Victor Chang Cardiac Research Institute
🇦🇺Darlinghurst, New South Wales, Australia