Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04496687




Registration number
NCT04496687
Ethics application status
Date submitted
29/07/2020
Date registered
3/08/2020
Date last updated
21/08/2023

Titles & IDs
Public title
International Spontaneous Coronary Artery Dissection (SCAD) "iSCAD" Registry
Scientific title
The International Spontaneous Coronary Artery Dissection "iSCAD" Registry (SCAD)
Secondary ID [1] 0 0
20190308
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spontaneous Coronary Artery Dissection 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Descriptive Data
Timepoint [1] 0 0
Continuous time frame following index event for an average of 3 years from study contact date
Primary outcome [2] 0 0
Clinical Outcomes
Timepoint [2] 0 0
Continuous time frame following index event for an average of 3 years from study contact date
Primary outcome [3] 0 0
Psychosocial Outcomes
Timepoint [3] 0 0
Continuous time frame following index event for an average of 3 years from study contact date

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Victor Chang Cardiac Research Institute - Darlinghurst
Recruitment postcode(s) [1] 0 0
NSW 2010 - Darlinghurst
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New Hampshire
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Other
Name
SCAD Alliance
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
PERFUSE Study Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04496687
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Esther Kim, MD
Address 0 0
Chair, Steering Committee
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Esther Kim, MD, MPH
Address 0 0
Country 0 0
Phone 0 0
704-373-0212
Fax 0 0
Email 0 0
Soo.Kim@atriumhealth.org
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04496687