Very Early veRsus Deferred Invasive Evaluation Using Computerized Tomography in Patients With Acute Coronary Syndromes

Coronary Artery Disease Clinical Trial

— VERDICT-EDI  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02061891
• Other study ID #: H-4-2010-039
• Secondary ID: EDITORS
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2010
• Est. completion date: May 2030

Study information

• Verified date: December 2022
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2500
• Est. completion date: May 2030
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Invasive coronary evaluation (Deferred)
Invasive coronary angiography and revascularization (PCI/CABG)
• Invasive coronary evaluation (Acute)
Invasive coronary angiography and revascularization (PCI/CABG)

Locations

Country	Name	City	State
Denmark	Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

Kristensen TS, Kofoed KF, Kuhl JT, Nielsen WB, Nielsen MB, Kelbaek H. Prognostic implications of nonobstructive coronary plaques in patients with non-ST-segment elevation myocardial infarction: a multidetector computed tomography study. J Am Coll Cardiol. 2011 Jul 26;58(5):502-9. doi: 10.1016/j.jacc.2011.01.058. — View Citation

Mehta SR, Granger CB, Boden WE, Steg PG, Bassand JP, Faxon DP, Afzal R, Chrolavicius S, Jolly SS, Widimsky P, Avezum A, Rupprecht HJ, Zhu J, Col J, Natarajan MK, Horsman C, Fox KA, Yusuf S; TIMACS Investigators. Early versus delayed invasive intervention in acute coronary syndromes. N Engl J Med. 2009 May 21;360(21):2165-75. doi: 10.1056/NEJMoa0807986. — View Citation

Navarese EP, Gurbel PA, Andreotti F, Tantry U, Jeong YH, Kozinski M, Engstrom T, Di Pasquale G, Kochman W, Ardissino D, Kedhi E, Stone GW, Kubica J. Optimal timing of coronary invasive strategy in non-ST-segment elevation acute coronary syndromes: a systematic review and meta-analysis. Ann Intern Med. 2013 Feb 19;158(4):261-70. doi: 10.7326/0003-4819-158-4-201302190-00006. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CCTA diagnostic accuracy	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
Other	CCTA guided treatment strategy	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
Other	CCTA prediction of clinical outcome	Clinical prognostic value of coronary pathology, cardiac and non-cardiac pathology identified by CCTA	3 and 5 years
Primary	Composite clinical endpoint	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	Bleeding	Major and minor bleeding according to TIMI and BARC classification systems	During index hospitalization - an expected average of 5 days
Secondary	Non-bleeding, invasive procedure related complications	Invasive procedure related acute myocardial infarction, embolic stroke, cardiac arrest	During index hospitalization - an expected average of 5 days
Secondary	Death	All-cause death	3 and 5 years
Secondary	Non-fatal acute myocardial infarction		3 and 5 years
Secondary	Hospital admittance due to refractory myocardial ischemia (acute coronary syndrome)		3 and 5 years
Secondary	Repeat coronary revascularization	Recorded from 30 days post-index procedure	3 and 5 years
Secondary	Hospital admittance due to left ventricular heart failure		3 and 5 years
Secondary	GRACE Risk Score	All primary and secondary endpoints stratified by GRACE score at a threshold of 140	3 and 5 years