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

NCT04496687 | Active Not Recruiting

• 1 other identifier: 20190308
• Study Type: observational
• Target: 2,000
• Locations: 2 countries
• Sites: 31

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.

Conditions

Spontaneous Coronary Artery Dissection

Keywords

spontaneous coronary artery dissection (SCAD); myocardial infarction; sudden cardiac arrest; acute coronary syndrome

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Spontaneous coronary artery dissection (SCAD) is defined as the non-traumatic, non-iatrogenic separation of the coronary arterial wall by intramural hemorrhage creating a false lumen, with or without an intimal tear. SCAD nearly always presents as an acute myocardial infarction. The prevalence of SCAD varies depending on the population studied. A goal of iSCAD Registry is to expand diversity of race, ethnicity, and sex of study participants. The mean age of SCAD presentation is 45-53 years of age, and appears to primarily affect women.

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SCAD Alliance: lead
• PERFUSE Study Group: collaborator

Study Sites (31)

Cedars Sinai

Los Angeles, California, 90048, United States

Location

UCLA (University of California, Los Angeles)

Los Angeles, California, 93003, United States

Location

Kaiser Permanente Northern California

San Francisco, California, 94115, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

University of South Florida

Tampa, Florida, 33602, United States

Location

Emory Healthcare System

Atlanta, Georgia, 30308, United States

Location

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

University of Kentucky

Lexington, Kentucky, 40508, United States

Location

Johns Hopkins

Baltimore, Maryland, 21224, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114-2696, United States

Location

St. Luke's Mid America

Kansas City, Missouri, 64111, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Dartmouth-Hitchcock

Lebanon, New Hampshire, 03756, United States

Location

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

Mount Sinai

New York, New York, 10029-6574, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Atrium Health Sanger Heart and Vascular Institute

Charlotte, North Carolina, 28204, United States

Location

University Hospitals--Case Western

Cleveland, Ohio, 44106, United States

Location

Oklahoma Heart

Oklahoma City, Oklahoma, 73120, United States

Location

Providence

Portland, Oregon, 97225, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny General Hospital, Allegheny Health Network

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

Intermountain

Murray, Utah, 84107, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Inova Heart & Vascular Institute

Fairfax, Virginia, 22031, United States

Location

University of Washington Medicine

Seattle, Washington, 98195, United States

Location

Victor Chang Cardiac Research Institute

Darlinghurst, New South Wales, NSW 2010, Australia

Location

Related Publications (1)

• Sumner JA, Kim ESH, Wood MJ, Chi G, Nolen J, Grodzinsky A, Gornik HL, Kadian-Dodov D, Wells BJ, Hess CN, Lewey J, Tam L, Henkin S, Orford J, Wells G, Kumbhani DJ, Lindley KJ, Gibson CM, Leon KK, Naderi S. Posttraumatic Stress Disorder After Spontaneous Coronary Artery Dissection: A Report of the International Spontaneous Coronary Artery Dissection Registry. J Am Heart Assoc. 2024 Apr 2;13(7):e032819. doi: 10.1161/JAHA.123.032819. Epub 2024 Mar 27.

  PMID: 38533943 DERIVED

Related Links

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

MeSH Terms

Conditions

Coronary Artery Dissection, Spontaneous; Myocardial Infarction; Death, Sudden, Cardiac; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Heart Arrest; Death, Sudden; Death

Study Officials

• Esther Kim, MD

  Chair, Steering Committee

  STUDY CHAIR

• Malissa Wood, MD

  Member, Steering Committee

  PRINCIPAL INVESTIGATOR

• Sahar Naderi, MD

  Member, Steering Committee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 3, 2020
• Study Start: March 8, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

AU (1); US (30)