Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

Please note that the ANZCTR will be unattended from Friday 18th April until Tuesday 22nd April due to the Easter long weekend. Submissions and updates will not be processed during that time.



Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04496687
Ethics application status
Date submitted
29/07/2020
Date registered
3/08/2020
Date last updated
17/12/2024

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
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
New Hampshire
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Utah
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington

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
Trial website
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
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04496687