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

NCT ID: NCT04496687

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-08

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Spontaneous Coronary Artery Dissection

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PERFUSE Study Group

UNKNOWN

Sponsor Role collaborator

SCAD Alliance

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Esther Kim, MD

Role: STUDY_CHAIR

Chair, Steering Committee

Malissa Wood, MD

Role: PRINCIPAL_INVESTIGATOR

Member, Steering Committee

Sahar Naderi, MD

Role: PRINCIPAL_INVESTIGATOR

Member, Steering Committee

Locations

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Cedars Sinai

Los Angeles, California, United States

Site Status RECRUITING

UCLA (University of California, Los Angeles)

Los Angeles, California, United States

Site Status RECRUITING

Kaiser Permanente Northern California

San Francisco, California, United States

Site Status RECRUITING

University of Colorado

Aurora, Colorado, United States

Site Status RECRUITING

Hartford Hospital

Hartford, Connecticut, United States

Site Status RECRUITING

University of South Florida

Tampa, Florida, United States

Site Status RECRUITING

Emory Healthcare System

Atlanta, Georgia, United States

Site Status RECRUITING

Northwestern Medicine

Chicago, Illinois, United States

Site Status RECRUITING

University of Kentucky

Lexington, Kentucky, United States

Site Status TERMINATED

Johns Hopkins

Baltimore, Maryland, United States

Site Status RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

St. Luke's Mid America

Kansas City, Missouri, United States

Site Status RECRUITING

Washington University

St Louis, Missouri, United States

Site Status TERMINATED

Dartmouth-Hitchcock

Lebanon, New Hampshire, United States

Site Status RECRUITING

Catholic Medical Center

Manchester, New Hampshire, United States

Site Status RECRUITING

Mount Sinai

New York, New York, United States

Site Status RECRUITING

Columbia University Medical Center

New York, New York, United States

Site Status RECRUITING

Atrium Health Sanger Heart and Vascular Institute

Charlotte, North Carolina, United States

Site Status RECRUITING

University Hospitals--Case Western

Cleveland, Ohio, United States

Site Status RECRUITING

Oklahoma Heart

Oklahoma City, Oklahoma, United States

Site Status TERMINATED

Providence

Portland, Oregon, United States

Site Status RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Allegheny General Hospital, Allegheny Health Network

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status RECRUITING

UT Southwestern

Dallas, Texas, United States

Site Status RECRUITING

Intermountain

Murray, Utah, United States

Site Status RECRUITING

University of Virginia

Charlottesville, Virginia, United States

Site Status RECRUITING

Inova Heart & Vascular Institute

Fairfax, Virginia, United States

Site Status RECRUITING

University of Washington Medicine

Seattle, Washington, United States

Site Status RECRUITING

Victor Chang Cardiac Research Institute

Darlinghurst, New South Wales, Australia

Site Status RECRUITING

Countries

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United States Australia

Central Contacts

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Esther Kim, MD, MPH

Role: CONTACT

Phone: 704-373-0212

Email: [email protected]

Facility Contacts

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Ana Iribarren, MD

Role: primary

Tim Canan, MD

Role: primary

Marcie Calfon Press, MD

Role: backup

Sahar Naderi, MD

Role: primary

Connie Hess, MD

Role: primary

Kylie Boynton

Role: backup

Stephanie Saucier, MD

Role: primary

Erika Zahina, MD

Role: backup

Daniela Crousillat, MD

Role: primary

Bryan Wells, MD

Role: primary

Mutsa Seremwe

Role: backup

Ranya Sweis, MD

Role: primary

Jeff Trost, MD

Role: primary

Anum Minhas, MD

Role: backup

Nandita Scott, MD

Role: primary

Anna Grodzinsky, MD

Role: primary

Carmen Butcher

Role: backup

Hannah Chaudry, MD

Role: primary

Michelle Ouellette, MD

Role: primary

Jennifer Driscoll

Role: backup

Daniella Kadian-Dodov, MD

Role: primary

Kimberly Capustin

Role: backup

Sonia Tolani, MD

Role: primary

Esther SH Kim, MD, MPH

Role: primary

Heather Gornik, MD

Role: primary

Nasla Tonni

Role: backup

Lori Tam, MD

Role: primary

Shawnna Verburg

Role: backup

Jennifer Lewey, MD

Role: primary

Tiffany Sharkosi

Role: backup

Indu Poornima, MD

Role: primary

Agnes Koczo, MD

Role: primary

Kathryn Lindley, MD

Role: primary

Olivia Patridge

Role: backup

Dharam Kumbhani, MD

Role: primary

Rina Mauricio, MD

Role: backup

James Orford, MD

Role: primary

Lorlie Evans

Role: backup

Patricia Rodriguez Lozano, MD

Role: primary

Linda Bryceland

Role: backup

Garima Sharma, MD

Role: primary

Kelley Branch, MD

Role: primary

Kate Kearney, MD

Role: backup

Jason C Kovacic, MBBS, PhD

Role: primary

Stephanie Hessleson, PhD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 38533943 (View on PubMed)

Related Links

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Other Identifiers

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20190308

Identifier Type: -

Identifier Source: org_study_id