Ignite Creation Date:
2024-05-06 @ 2:33 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02061891
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-12-12
First Post:
2014-02-06
Brief Title:
Very Early veRsus Deferred Invasive Evaluation Using Computerized Tomography in Patients With Acute Coronary Syndromes
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Entire Danish Initiative To ImrpOve Revascularization Strategies EDITORS - A Randomised Evaluation of Clinical Outcome After Acute or Deferred Invasive Intervention Integrated With MDCT Imaging in Patients With Acute Coronary Syndromes
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-12
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:
VERDICT-EDI
Brief Summary:
The aim of this study is to evaluate if acute invasive coronary evaluation and treatment conducted within 12 hours of diagnosis improves clinical outcome compared to a deferred subacute strategy in patients with unstable angina pectoris UAP non-ST segment elevation myocardial infarction NSTEMI Acute coronary syndrome ACS Furthermore in an observational design the potential clinical benefit of coronary computed tomography angiography CCTA to select patients for invasive investigation and treatment in the two treatment arms acute vs deferred is evaluated
The following main hypothesis will be tested
Very early invasive coronary investigation improves clinical outcome in patients with UAPNSTEMI-ACS
CCTA performed before invasive coronary investigation will improve clinical management of patients with UAPNSTEMI-ACS
The following main hypothesis will be tested
Very early invasive coronary investigation improves clinical outcome in patients with UAPNSTEMI-ACS
CCTA performed before invasive coronary investigation will improve clinical management of patients with UAPNSTEMI-ACS
Detailed Description:
MATERIAL Consecutive patients suspected of UAPNSTEMI will be screened for participation in the study Only patients deemed clinically suited for invasive coronary evaluation and treatment will be included A total of 2500 patients will be included in the trial at Departments of Cardiology of Danish Hospitals
METHODS If the patients accept participation in the trial a computerized 11 randomization for acute invasive coronary evaluation Intervention group - within 12 hours from time of diagnosis or for deferred invasive evaluation Control group - no later than 72 hours from time of diagnosis All included patients undergo CCTA prior to invasive coronary evaluation except for patient with moderately reduced renal function se below The treating invasive cardiologist will remain blinded to observational CCTA data Patients with endstage renal disease in dialysis may undergo CCTA CCTA data recorded as part of the research protocol will not be made available for the treating physician
SECONDARY EXCLUSION Based on post-hoc expert clinical evaluation patients not having UAPNSTEMI-ACS arrythmias pulmonary oedema missed STEMI pneumonia Pulmonary emboli will be excluded from analysis of difference between outcome measures in treatment strategy groups
STATISTICAL METHODS Patients with UAPNSTEMI-ACS are based on previous studies expected to have an event rate of 15 within 1 year and 50 at 4 years of the primary combined endpoint all cause mortality non-fatal recurrent myocardial infarction hospitalisation for refractory ischemia or heart failure In order to demonstrate a reduction of 25 within 3 years 711 patients in each group are needed The study is powered to detect a clinical relevant reduction in mortality or heart failure hospitalization with a total of 2500 patients
METHODS If the patients accept participation in the trial a computerized 11 randomization for acute invasive coronary evaluation Intervention group - within 12 hours from time of diagnosis or for deferred invasive evaluation Control group - no later than 72 hours from time of diagnosis All included patients undergo CCTA prior to invasive coronary evaluation except for patient with moderately reduced renal function se below The treating invasive cardiologist will remain blinded to observational CCTA data Patients with endstage renal disease in dialysis may undergo CCTA CCTA data recorded as part of the research protocol will not be made available for the treating physician
SECONDARY EXCLUSION Based on post-hoc expert clinical evaluation patients not having UAPNSTEMI-ACS arrythmias pulmonary oedema missed STEMI pneumonia Pulmonary emboli will be excluded from analysis of difference between outcome measures in treatment strategy groups
STATISTICAL METHODS Patients with UAPNSTEMI-ACS are based on previous studies expected to have an event rate of 15 within 1 year and 50 at 4 years of the primary combined endpoint all cause mortality non-fatal recurrent myocardial infarction hospitalisation for refractory ischemia or heart failure In order to demonstrate a reduction of 25 within 3 years 711 patients in each group are needed The study is powered to detect a clinical relevant reduction in mortality or heart failure hospitalization with a total of 2500 patients
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 |
|---|---|---|---|
| EDITORS | OTHER | The Danish Council for Strategic Research 09-066994 | None |