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Spontaneous Coronary Artery DissectionNCT04496687

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

An observational study of Spontaneous Coronary Artery Dissection, run by SCAD Alliance at 31 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spontaneous Coronary Artery Dissection
How many people
2,000 participants
Where
31 sitesin 2 countries
Study dates
8 Mar 2019to 31 Dec 2026
How long will I take part?
3 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

31 sites in 2 countries.

31 sites in 2 countries

United States30 sites

  • Emory Healthcare System

    Atlanta, Georgia, 30308

  • University of Colorado

    Aurora, Colorado, 80045

  • Johns Hopkins

    Baltimore, Maryland, 21224

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114-2696

  • Atrium Health Sanger Heart and Vascular Institute

    Charlotte, North Carolina, 28204

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Northwestern Medicine

    Chicago, Illinois, 60611

  • University Hospitals--Case Western

    Cleveland, Ohio, 44106

  • UT Southwestern

    Dallas, Texas, 75390

  • Inova Heart & Vascular Institute

    Fairfax, Virginia, 22031

  • Hartford Hospital

    Hartford, Connecticut, 06106

  • St. Luke's Mid America

    Kansas City, Missouri, 64111

  • Dartmouth-Hitchcock

    Lebanon, New Hampshire, 03756

  • University of Kentucky

    Lexington, Kentucky, 40508

  • Cedars Sinai

    Los Angeles, California, 90048

  • UCLA (University of California, Los Angeles)

    Los Angeles, California, 93003

  • Catholic Medical Center

    Manchester, New Hampshire, 03102

  • Intermountain

    Murray, Utah, 84107

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Mount Sinai

    New York, New York, 10029-6574

  • Columbia University Medical Center

    New York, New York, 10032

  • Oklahoma Heart

    Oklahoma City, Oklahoma, 73120

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Allegheny General Hospital, Allegheny Health Network

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Providence

    Portland, Oregon, 97225

  • Kaiser Permanente Northern California

    San Francisco, California, 94115

  • University of Washington Medicine

    Seattle, Washington, 98195

  • Washington University

    St Louis, Missouri, 63110

  • University of South Florida

    Tampa, Florida, 33602

Other trials in United States

Australia1 site

  • Victor Chang Cardiac Research Institute

    Darlinghurst, New South Wales, NSW 2010

Other trials in Australia

About this study

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

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.

Read the 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.

Keywords
spontaneous coronary artery dissection (SCAD), myocardial infarction, sudden cardiac arrest, acute coronary syndrome
Medical subject headings
Coronary Artery Dissection, Spontaneous, Myocardial Infarction, Death, Sudden, Cardiac, Acute Coronary Syndrome

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Descriptive Data

    Participant demographic, historical, clinical characteristics, and treatment data

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

  2. Clinical Outcomes

    Prospectively collected long-term outcomes including recurrent myocardial infarction, hospitalization, heart failure, stroke or transient ischemic attack, arrhythmia, and all cause mortality

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

  3. Psychosocial Outcomes

    Prospectively collected data on participant's mental health using validated questionnaires

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2020
  2. Study start8 Mar 2019
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
2,000 participants (actual)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04496687
Sponsor's protocol ID
20190308
Status last verified
May 2026
First submitted
29 Jul 2020
Last updated
6 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chi G, Kim ESH, Gornik HL, Grodzinsky A, Wells BJ, Lewey J, Kadian-Dodov D, Taylor AM, Hess CN, Tam LM, Mauricio R, Henkin S, Lindley KJ, Orford JL, Tolani S, Alkhalfan F, Reyes C, Gibson CM, Leon KK, Naderi S, Scott NS, Wood MJ. Patient characteristics and incidence of in-hospital events in spontaneous coronary artery dissection and suspected concurrent Takotsubo syndrome: A report of the iSCAD registry. Am Heart J Plus. 2026 May 9;66:100793. doi: 10.1016/j.ahjo.2026.100793. eCollection 2026 Jun.

    PubMed 42199296

  • 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.

    PubMed 38533943

Questions about this trial

What is this clinical trial studying?

An observational study of Spontaneous Coronary Artery Dissection, run by SCAD Alliance at 31 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Descriptive Data (time frame: Continuous time frame following index event for an average of 3 years from study contact date). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04496687, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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