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

Recruiting

• 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.

Study Timeline

• Study Start: 2019-03-08
• Study First Submitted: 2020-07-29
• Study First Submitted QC: 2020-07-29
• Study First Posted: 2020-08-03
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

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

Trial Locations

Locations (31)

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

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