Very Early veRsus Deferred Invasive Evaluation Using Computerized Tomography in Patients With Acute Coronary Syndromes
NCT ID: NCT02061891
Last Updated: 2022-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
2500 participants
INTERVENTIONAL
2010-11-30
2030-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Deferred invasive evaluation
Deferred invasive coronary evaluation and revascularization (PCI/CABG) within 72 hours from time of clinical diagnosis (CONTROL group)
Invasive coronary evaluation (Deferred)
Invasive coronary angiography and revascularization (PCI/CABG)
Very early invasive evaluation
Acute invasive coronary evaluation within 12 hours from time of diagnosis - INTERVENTION group
Invasive coronary evaluation (Acute)
Invasive coronary angiography and revascularization (PCI/CABG)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Invasive coronary evaluation (Deferred)
Invasive coronary angiography and revascularization (PCI/CABG)
Invasive coronary evaluation (Acute)
Invasive coronary angiography and revascularization (PCI/CABG)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Gentofte, Copenhagen
OTHER
Rigshospitalet, Denmark
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Klaus Fuglsang Kofoed
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lars V Køber, MD, DmSc
Role: STUDY_CHAIR
Department of Cardiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen, Denmark
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
Copenhagen, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Ratcovich H, Sadjadieh G, Linde JJ, Joshi FR, Kelbaek H, Kofoed KF, Kober L, Hansen PR, Torp-Pedersen C, Elming H, Gislason GH, Hofsten DE, Engstrom T, Holmvang L. Coronary CT and timing of invasive coronary angiography in patients >/=75 years old with non-ST segment elevation acute coronary syndromes. Heart. 2023 Feb 23;109(6):457-463. doi: 10.1136/heartjnl-2022-321640.
Butt JH, Kofoed KF, Kelbaek H, Hansen PR, Torp-Pedersen C, Hofsten D, Holmvang L, Pedersen F, Bang LE, Sigvardsen PE, Clemmensen P, Linde JJ, Heitmann M, Hove JD, Abdulla J, Gislason G, Engstrom T, Kober L. Importance of Risk Assessment in Timing of Invasive Coronary Evaluation and Treatment of Patients With Non-ST-Segment-Elevation Acute Coronary Syndrome: Insights From the VERDICT Trial. J Am Heart Assoc. 2021 Oct 5;10(19):e022333. doi: 10.1161/JAHA.121.022333. Epub 2021 Sep 29.
Kofoed KF, Engstrom T, Sigvardsen PE, Linde JJ, Torp-Pedersen C, de Knegt M, Hansen PR, Fritz-Hansen T, Bech J, Heitmann M, Nielsen OW, Hofsten D, Kuhl JT, Raymond IE, Kristiansen OP, Svendsen IH, Dominguez Vall-Lamora MH, Kragelund C, Hove JD, Jorgensen T, Fornitz GG, Steffensen R, Jurlander B, Abdulla J, Lyngbaek S, Elming H, Therkelsen SK, Jorgensen E, Klovgaard L, Bang LE, Helqvist S, Galatius S, Pedersen F, Abildgaard U, Clemmensen P, Saunamaki K, Holmvang L, Gislason G, Kelbaek H, Kober LV. Prognostic Value of Coronary CT Angiography in Patients With Non-ST-Segment Elevation Acute Coronary Syndromes. J Am Coll Cardiol. 2021 Mar 2;77(8):1044-1052. doi: 10.1016/j.jacc.2020.12.037.
Linde JJ, Kelbaek H, Hansen TF, Sigvardsen PE, Torp-Pedersen C, Bech J, Heitmann M, Nielsen OW, Hofsten D, Kuhl JT, Raymond IE, Kristiansen OP, Svendsen IH, Vall-Lamora MHD, Kragelund C, de Knegt M, Hove JD, Jorgensen T, Fornitz GG, Steffensen R, Jurlander B, Abdulla J, Lyngbaek S, Elming H, Therkelsen SK, Jorgensen E, Klovgaard L, Bang LE, Hansen PR, Helqvist S, Galatius S, Pedersen F, Abildgaard U, Clemmensen P, Saunamaki K, Holmvang L, Engstrom T, Gislason G, Kober LV, Kofoed KF. Coronary CT Angiography in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome. J Am Coll Cardiol. 2020 Feb 11;75(5):453-463. doi: 10.1016/j.jacc.2019.12.012.
Kofoed KF, Kelbaek H, Hansen PR, Torp-Pedersen C, Hofsten D, Klovgaard L, Holmvang L, Helqvist S, Jorgensen E, Galatius S, Pedersen F, Bang L, Saunamaki K, Clemmensen P, Linde JJ, Heitmann M, Wendelboe Nielsen O, Raymond IE, Kristiansen OP, Svendsen IH, Bech J, Dominguez Vall-Lamora MH, Kragelund C, Hansen TF, Dahlgaard Hove J, Jorgensen T, Fornitz GG, Steffensen R, Jurlander B, Abdulla J, Lyngbaek S, Elming H, Therkelsen SK, Abildgaard U, Jensen JS, Gislason G, Kober LV, Engstrom T. Early Versus Standard Care Invasive Examination and Treatment of Patients With Non-ST-Segment Elevation Acute Coronary Syndrome. Circulation. 2018 Dec 11;138(24):2741-2750. doi: 10.1161/CIRCULATIONAHA.118.037152.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EDITORS
Identifier Type: OTHER
Identifier Source: secondary_id
H-4-2010-039
Identifier Type: -
Identifier Source: org_study_id