Clinical trial NCT02061891: Very Early veRsus Deferred Invasive Evaluation Using Computerized Tomography in Patients With Acute Coronary Syndromes
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary Stenosis
Coronary Artery Disease
Acute coronary syndrome
Percutaneous Coronary Intervention
Multidetector Computed Tomography
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: University Hospital, Gentofte, Copenhagen
First posted: 2014-02-13
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 UAP/NSTEMI-ACS
* CCTA performed before invasive coronary investigation will improve clinical management of patients with UAP/NSTEMI-ACS

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Patients with clinical suspicion of of UAP/NSTEMI acute coronary syndrome deemed suitable for invasive evaluation and treatment will be included in the study.

* Age\> 18 years
* At least one of the following:
* ECG abnormalities suggestive of myocardial ischemia (newly developed ST segment depression, horizontal or descending \>= 0,05mV in two anatomically adjacent leads and/or T-wave inversion \>0,01 mV in two leads with prominent R wave or R/S ratio \>1
* Elevated myocardial ischemia biomarkers (Troponin, CK-MB)

Exclusion Criteria:

* Pregnancy
* Circumstances preventing the patient from reading and/or understanding the research protocol information
* Clinical indication for acute invasive coronary angiography - severe chest pain despite intravenous nitroglycerin infusion or hemodynamic instability
* Expected survival of less than 1 year
* Known allergy/hypersensitivity of pharmacological platelet inhibitors and/or iodine contrast that cannot be prevented medically

Patients with known eGFR below 60 ml/min will not undergo CCTA, whereas patients in dialysis will undergo the entire study protocol

Primary outcomes:
measure: Composite clinical endpoint
timeFrame: 3 years
Secondary outcomes:
measure: Bleeding
timeFrame: During index hospitalization - an expected average of 5 days
measure: Non-bleeding, invasive procedure related complications
timeFrame: During index hospitalization - an expected average of 5 days
measure: Death
timeFrame: 3 and 5 years
measure: Non-fatal acute myocardial infarction
timeFrame: 3 and 5 years
measure: Hospital admittance due to refractory myocardial ischemia (acute coronary syndrome)
timeFrame: 3 and 5 years
measure: Repeat coronary revascularization
timeFrame: 3 and 5 years
measure: Hospital admittance due to left ventricular heart failure
timeFrame: 3 and 5 years
measure: GRACE Risk Score
timeFrame: 3 and 5 years
Other outcomes:
measure: CCTA diagnostic accuracy
timeFrame: Within 30 days after performed CCTA and ICA
measure: CCTA guided treatment strategy
timeFrame: Within 30 days after performed CCTA and ICA
measure: CCTA prediction of clinical outcome
timeFrame: 3 and 5 years
Locations:
city: Copenhagen
country: Denmark
facility: Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
Study officials:
affiliation: Department of Cardiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen, Denmark
name: Lars V Køber, MD, DmSc
role: STUDY_CHAIR
References:
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