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

NCT02061891 | Active Not Recruiting DMC

• 2 other identifiers: H-4-2010-039EDITORS
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Artery Disease

Keywords

Coronary Stenosis; Coronary Artery Disease; Acute coronary syndrome; Percutaneous Coronary Intervention; Multidetector Computed Tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Bleeding

  During index hospitalization - an expected average of 5 days

• Non-bleeding, invasive procedure related complications

  During index hospitalization - an expected average of 5 days

• Death

  3 and 5 years

• Non-fatal acute myocardial infarction

  3 and 5 years

• Hospital admittance due to refractory myocardial ischemia (acute coronary syndrome)

  3 and 5 years

Other Outcomes (3)

• CCTA diagnostic accuracy

  Within 30 days after performed CCTA and ICA

• CCTA guided treatment strategy

  Within 30 days after performed CCTA and ICA

• CCTA prediction of clinical outcome

  3 and 5 years

Study Arms (2)

Deferred invasive evaluation

ACTIVE COMPARATOR

Deferred invasive coronary evaluation and revascularization (PCI/CABG) within 72 hours from time of clinical diagnosis (CONTROL group)

Procedure: Invasive coronary evaluation (Deferred)

Very early invasive evaluation

EXPERIMENTAL

Acute invasive coronary evaluation within 12 hours from time of diagnosis - INTERVENTION group

Procedure: Invasive coronary evaluation (Acute)

Interventions

Invasive coronary evaluation (Deferred) PROCEDURE

Invasive coronary angiography and revascularization (PCI/CABG)

Deferred invasive evaluation

Invasive coronary evaluation (Acute) PROCEDURE

Invasive coronary angiography and revascularization (PCI/CABG)

Very early invasive evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• University Hospital, Gentofte, Copenhagen: collaborator

Study Sites (1)

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

Copenhagen, 2100, Denmark

Location

Related Publications (8)

• 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.

  PMID: 23420234 BACKGROUND

• 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.

  PMID: 19458363 BACKGROUND

• 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.

  PMID: 21777748 BACKGROUND

• 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.

  PMID: 36351794 DERIVED

• 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.

  PMID: 34585591 DERIVED

• 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.

  PMID: 33632478 DERIVED

• 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.

  PMID: 32029126 DERIVED

• 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.

  PMID: 30565996 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Lars V Køber, MD, DmSc

  Department of Cardiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: February 13, 2014
• Study Start: November 1, 2010
• Primary Completion: June 1, 2016
• Study Completion (Estimated): May 1, 2030
• Last Updated: December 12, 2022

Record last verified: 2022-12

Locations

DK (1)