Very Early veRsus Deferred Invasive Evaluation Using Computerized Tomography in Patients With Acute Coronary Syndromes (VERDICT-EDI)
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 UAP/NSTEMI-ACS
- CCTA performed before invasive coronary investigation will improve clinical management of patients with UAP/NSTEMI-ACS
|Coronary Artery Disease||Procedure: Invasive coronary evaluation (Deferred) Procedure: Invasive coronary evaluation (Acute)|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|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|
- Composite clinical endpoint [ Time Frame: 3 years ]Composite endpoint of all cause mortality, non-fatal recurrent acute myocardial infarction, hospitalisation for refractory ischemia (acute coronary syndrome) or heart failure
- Bleeding [ Time Frame: During index hospitalization - an expected average of 5 days ]Major and minor bleeding according to TIMI and BARC classification systems
- Non-bleeding, invasive procedure related complications [ Time Frame: During index hospitalization - an expected average of 5 days ]Invasive procedure related acute myocardial infarction, embolic stroke, cardiac arrest
- Death [ Time Frame: 3 and 5 years ]All-cause death
- Non-fatal acute myocardial infarction [ Time Frame: 3 and 5 years ]
- Hospital admittance due to refractory myocardial ischemia (acute coronary syndrome) [ Time Frame: 3 and 5 years ]
- Repeat coronary revascularization [ Time Frame: 3 and 5 years ]Recorded from 30 days post-index procedure
- Hospital admittance due to left ventricular heart failure [ Time Frame: 3 and 5 years ]
- GRACE Risk Score [ Time Frame: 3 and 5 years ]All primary and secondary endpoints stratified by GRACE score at a threshold of 140
- CCTA diagnostic accuracy [ Time Frame: Within 30 days after performed CCTA and ICA ]Determinants of diagnostic accuracy of CCTA for the identification of >50% and >70% coronary artery stenosis by invasive coronary angiography in both treatment strategy groups
- CCTA guided treatment strategy [ Time Frame: Within 30 days after performed CCTA and ICA ]Prediction of clinical treatment strategy based on CCTA - and the potential value of CCTA guided triage in terms of optimized patient management. Evaluation will be performed blinded to ICA findings.
- CCTA prediction of clinical outcome [ Time Frame: 3 and 5 years ]Clinical prognostic value of coronary pathology, cardiac and non-cardiac pathology identified by CCTA
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||June 2017|
|Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Deferred invasive evaluation
Deferred invasive coronary evaluation and revascularization (PCI/CABG) within 72 hours from time of clinical diagnosis (CONTROL group)
Procedure: Invasive coronary evaluation (Deferred)
Invasive coronary angiography and revascularization (PCI/CABG)
Experimental: Very early invasive evaluation
Acute invasive coronary evaluation within 12 hours from time of diagnosis - INTERVENTION group
Procedure: Invasive coronary evaluation (Acute)
Invasive coronary angiography and revascularization (PCI/CABG)
MATERIAL Consecutive patients suspected of UAP/NSTEMI 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 1:1 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 UAP/NSTEMI-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 UAP/NSTEMI-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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02061891
|Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen|
|Copenhagen, Denmark, 2100|
|Study Chair:||Lars V Køber, MD, DmSc||Department of Cardiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen, Denmark|