Ignite Creation Date:
2024-05-05 @ 10:08 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01032018
Status:
COMPLETED
Last Update Posted:
2017-09-13
First Post:
2009-12-11
Brief Title:
Comparison of Depression Interventions After Acute Coronary Syndrome
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Comparison of Depression Interventions After Acute Coronary Syndrome CODIACS
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CODIACS
Brief Summary:
Patients will be consented and screened within 2 to 6 months of the index ACS Patients who have elevated depression BDI15 or BDI10 assessed twice over two week period and who continue to meet all of the trials eligibility criteria will be consented Through informed consent both arms of the trial will be described with equipoise as to these approaches to postACS depression care Patients who consent to randomization will be enrolled in the treatment trial
The intervention phase will be 6 months and hence the final outcome assessments will be performed approximately 9 months after the index ACS Interim measures of depression will be obtained at 2 and 4 months post-enrollment Major adverse cardiac events and all-cause mortality will also be ascertained at 6 months post-enrollment Quality assurance by an independent medical event adjudication committee using prospective guidelines will be employed
The intervention phase will be 6 months and hence the final outcome assessments will be performed approximately 9 months after the index ACS Interim measures of depression will be obtained at 2 and 4 months post-enrollment Major adverse cardiac events and all-cause mortality will also be ascertained at 6 months post-enrollment Quality assurance by an independent medical event adjudication committee using prospective guidelines will be employed
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RC2HL101663 | NIH | None | httpsreporternihgovquickSearchRC2HL101663 |