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

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ClinicalTrials.gov Identifier: NCT04496687
Recruitment Status : Recruiting
First Posted : August 3, 2020
Last Update Posted : December 2, 2020
Sponsor:
Collaborator:
PERFUSE Academic Research Organization
Information provided by (Responsible Party):
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.


Condition or disease
Spontaneous Coronary Artery Dissection

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 3 Years
Official Title: The International Spontaneous Coronary Artery Dissection "iSCAD" Registry (SCAD)
Actual Study Start Date : March 8, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04496687


Contacts
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Contact: Esther Kim, MD (615) 322-2318 registry@scadalliance.org

Locations
Show Show 17 study locations
Sponsors and Collaborators
SCAD Alliance
PERFUSE Academic Research Organization
Investigators
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Study Chair: Esther Kim, MD Chair, Steering Committee
Principal Investigator: Malissa Wood, MD Member, Steering Committee
Principal Investigator: Sahar Naderi, MD Member, Steering Committee
Additional Information:
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Responsible Party: SCAD Alliance
ClinicalTrials.gov Identifier: NCT04496687    
Other Study ID Numbers: 20190308
First Posted: August 3, 2020    Key Record Dates
Last Update Posted: December 2, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SCAD Alliance:
spontaneous coronary artery dissection (SCAD)
myocardial infarction
sudden cardiac arrest
acute coronary syndrome
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Aneurysm
Vascular Diseases
Cardiovascular Diseases