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Very Early veRsus Deferred Invasive Evaluation Using Computerized Tomography in Patients With Acute Coronary Syndromes (VERDICT-EDI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Rigshospitalet, Denmark
Sponsor:
Collaborator:
University Hospital, Gentofte, Copenhagen
Information provided by (Responsible Party):
Klaus Fuglsang Kofoed, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT02061891
First received: February 6, 2014
Last updated: November 4, 2014
Last verified: November 2014
  Purpose

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

Condition Intervention
Coronary Artery Disease
Procedure: Invasive coronary evaluation (Deferred)
Procedure: Invasive coronary evaluation (Acute)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Composite clinical endpoint [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Composite endpoint of all cause mortality, non-fatal recurrent acute myocardial infarction, hospitalisation for refractory ischemia (acute coronary syndrome) or heart failure


Secondary Outcome Measures:
  • Bleeding [ Time Frame: During index hospitalization - an expected average of 5 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Invasive procedure related acute myocardial infarction, embolic stroke, cardiac arrest

  • Death [ Time Frame: 3 and 5 years ] [ Designated as safety issue: No ]
    All-cause death

  • Non-fatal acute myocardial infarction [ Time Frame: 3 and 5 years ] [ Designated as safety issue: No ]
  • Hospital admittance due to refractory myocardial ischemia (acute coronary syndrome) [ Time Frame: 3 and 5 years ] [ Designated as safety issue: No ]
  • Repeat coronary revascularization [ Time Frame: 3 and 5 years ] [ Designated as safety issue: No ]
    Recorded from 30 days post-index procedure

  • Hospital admittance due to left ventricular heart failure [ Time Frame: 3 and 5 years ] [ Designated as safety issue: No ]
  • GRACE Risk Score [ Time Frame: 3 and 5 years ] [ Designated as safety issue: No ]
    All primary and secondary endpoints stratified by GRACE score at a threshold of 140


Other Outcome Measures:
  • CCTA diagnostic accuracy [ Time Frame: Within 30 days after performed CCTA and ICA ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Clinical prognostic value of coronary pathology, cardiac and non-cardiac pathology identified by CCTA


Estimated Enrollment: 2500
Study Start Date: November 2010
Estimated Study Completion Date: November 2020
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02061891

Contacts
Contact: Lars V Køber, MD, DmSc +45 35458525 LK@heart.dk
Contact: Klaus F Kofoed, MD, DmSc +45 35458569 kkofoed@dadlnet.dk

Locations
Denmark
Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen Recruiting
Copenhagen, Denmark, 2100
Contact: Lars V Køber, MD, DmSc    +4535458525    lk@heart.dk   
Contact: Klaus F Kofoed, MD, DmSc    +4535458569    kkofoed@dadlnet.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
University Hospital, Gentofte, Copenhagen
Investigators
Study Chair: Lars V Køber, MD, DmSc Department of Cardiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen, Denmark
  More Information

Additional Information:
Publications:
Responsible Party: Klaus Fuglsang Kofoed, Associate Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02061891     History of Changes
Other Study ID Numbers: H-4-2010-039, EDITORS
Study First Received: February 6, 2014
Last Updated: November 4, 2014
Health Authority: Denmark: National Board of Health
Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
Coronary Stenosis
Coronary Artery Disease
Acute coronary syndrome
Percutaneous Coronary Intervention
Multidetector Computed Tomography

Additional relevant MeSH terms:
Acute Coronary Syndrome
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Syndrome
Angina Pectoris
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014