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

December 9, 2022 updated by: Klaus Fuglsang Kofoed, Rigshospitalet, Denmark

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

2500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding
Time Frame: During index hospitalization - an expected average of 5 days
Major and minor bleeding according to TIMI and BARC classification systems
During index hospitalization - an expected average of 5 days
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
During index hospitalization - an expected average of 5 days
Death
Time Frame: 3 and 5 years
All-cause death
3 and 5 years
Non-fatal acute myocardial infarction
Time Frame: 3 and 5 years
3 and 5 years
Hospital admittance due to refractory myocardial ischemia (acute coronary syndrome)
Time Frame: 3 and 5 years
3 and 5 years
Repeat coronary revascularization
Time Frame: 3 and 5 years
Recorded from 30 days post-index procedure
3 and 5 years
Hospital admittance due to left ventricular heart failure
Time Frame: 3 and 5 years
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
3 and 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 30 days after performed CCTA and ICA
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.
Within 30 days after performed CCTA and ICA
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
3 and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

June 1, 2016

Study Completion (Anticipated)

May 1, 2030

Study Registration Dates

First Submitted

February 6, 2014

First Submitted That Met QC Criteria

February 11, 2014

First Posted (Estimate)

February 13, 2014

Study Record Updates

Last Update Posted (Estimate)

December 12, 2022

Last Update Submitted That Met QC Criteria

December 9, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-4-2010-039
  • EDITORS (Other Identifier: The Danish Council for Strategic Research (09-066994))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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