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Active, Not Recruiting

NCT Number: NCT04496687

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Victor Chang Cardiac Research Institute, Darlinghurst, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Descriptive Data

    Time frame: Continuous time frame following index event for an average of 3 years from study contact date

    Participant demographic, historical, clinical characteristics, and treatment data

  2. Clinical Outcomes

    Time frame: 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

  3. Psychosocial Outcomes

    Time frame: 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

Sponsors and collaborators

Lead sponsor

SCAD Alliance

Other

Collaborators

  • PERFUSE Study Group

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Aug 3, 2020
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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