International Spontaneous Coronary Artery Dissection (SCAD) "iSCAD" Registry

Spontaneous Coronary Artery Dissection Clinical Trial

Official title:

The International Spontaneous Coronary Artery Dissection "iSCAD" Registry (SCAD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04496687
• Other study ID #: 20190308
• Status: Recruiting
• Start date: March 8, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: SCAD Alliance
• Contact: Esther Kim, MD, MPH
• Phone: 704-373-0212
• Email: Soo.Kim[@]atriumhealth.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Participants with a new diagnosis of SCAD or a history of confirmed or suspected SCAD will be prospectively recruited from either:

1. Inpatient wards of the enrolling medical centers during the acute presentation of SCAD, or

2. 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:

1. Coronary dissection in association with atherosclerosis or as a result of iatrogenic injury

2. Inability to provide informed consent

3. Inability to complete study-related patient questionnaires

4. Inability to understand and complete patient questionnaires independently

Related Conditions & MeSH terms

• Aortic Dissection
• Coronary Vessel Anomalies
• Spontaneous Coronary Artery Dissection
• Vascular Diseases

Locations

Country	Name	City	State
Australia	Victor Chang Cardiac Research Institute	Darlinghurst	New South Wales
United States	Emory Healthcare System	Atlanta	Georgia
United States	University of Colorado	Aurora	Colorado
United States	Johns Hopkins	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Atrium Health Sanger Heart and Vascular Institute	Charlotte	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	University Hospitals--Case Western	Cleveland	Ohio
United States	UT Southwestern	Dallas	Texas
United States	Hartford Hospital	Hartford	Connecticut
United States	St. Luke's Mid America	Kansas City	Missouri
United States	Dartmouth-Hitchcock	Lebanon	New Hampshire
United States	University of Kentucky	Lexington	Kentucky
United States	UCLA (University of California, Los Angeles)	Los Angeles	California
United States	Catholic Medical Center	Manchester	New Hampshire
United States	Intermountain	Murray	Utah
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	Mount Sinai	New York	New York
United States	Oklahoma Heart	Oklahoma City	Oklahoma
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Providence	Portland	Oregon
United States	Washington University	Saint Louis	Missouri
United States	Kaiser Permanente Northern California	San Francisco	California
United States	University of South Florida	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
SCAD Alliance	PERFUSE Study Group

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Descriptive Data	Participant demographic, historical, clinical characteristics, and treatment data	Continuous time frame following index event for an average of 3 years from study contact date
Primary	Clinical Outcomes	Prospectively collected long-term outcomes including recurrent myocardial infarction, hospitalization, heart failure, stroke or transient ischemic attack, arrhythmia, and all cause mortality	Continuous time frame following index event for an average of 3 years from study contact date
Primary	Psychosocial Outcomes	Prospectively collected data on participant's mental health using validated questionnaires	Continuous time frame following index event for an average of 3 years from study contact date

External Links

•   iSCAD Registry FAQs and sponsor page
•   iSCAD Registry Home Page