Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06601270
Status:
RECRUITING
Last Update Posted:
None
First Post:
2020-10-15
Brief Title:
SCAD a Registry of Spontaneous Coronary Artery Dissection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Registry of Spontaneous Coronary Artery Dissection
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCAD
Brief Summary:
Spontaneous coronary artery dissection SCAD is an increasingly recognised cause of non-atherosclerotic acute coronary syndromes ACS predominantly afflicting young women without conventional atherosclerotic risk factors Knowledge of SCAD has advanced considerably in the last few years as a result of data from a number of local and national registries 1-6 Like all rarer diseases however a better understanding of SCAD will require international collaboration At present there is no European or International SCAD registry despite increasing recognition that there are key differences in the diagnosis interventional and medical management of SCAD compared with conventional atherosclerotic ACS The ESC-ACCA Study Group on Spontaneous Coronary Artery Dissection supported by the European Observational Research Programme will now build the first pan-European SCAD registry to advance our understanding of current management of this condition inform guidelines educate clinical colleagues and advance research
Detailed Description:
Observational multicentre international retrospective and prospective cohort study
Since this is an observational study a formal sample size is not necessary At least 500 prospectively recruited patients and 500 historical cases will be enrolled
Patient data will be collected at the following time-points
First SCAD event visit retrospectively on chart review
First follow-up at time of enrolment
Yearly follow-up up to 1 2 3 4 and 5 years post enrolment or until study completion
Approximately 30 countries and 120 sites will participate in this registry
Since this is an observational study a formal sample size is not necessary At least 500 prospectively recruited patients and 500 historical cases will be enrolled
Patient data will be collected at the following time-points
First SCAD event visit retrospectively on chart review
First follow-up at time of enrolment
Yearly follow-up up to 1 2 3 4 and 5 years post enrolment or until study completion
Approximately 30 countries and 120 sites will participate in this registry
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None