Diagnostic Accuracy of ECG-less Gated Cardiac CT in Resuscitated Cardiac Arrest Survivors Without ST Elevation Myocardial Infarction

NCT07388342 | Recruiting DMC FDA Device

• 1 other identifier: 1432025000122
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

In a significant portion of patients surviving a cardiac arrest, the event is caused by a myocardial infarction (a narrowing or blockage of one or more blood vessels that supply blood to the heart, the coronary arteries). In some people, this is immediately evident from basic tests; in others, it is more difficult to predict with the currently available tests whether this (or something else) caused the cardiac arrest. We investigate a technique that allows us to also assess the coronary arteries on the CT scan that is performed in patients surviving a cardiac arrest. The coronary angiography is currently the best exam we have for examining the coronary arteries, but it has some disadvantages. Compared to the CT scan, it takes more time, needs a more complex access to the blood vessels, and has some rare but relevant possible complications. The major advantage of the coronary angiography is that there is the possibility of immediate treatment of a narrowed/blocked blood vessel of the heart. The current guidelines advice an urgent coronary angiography when a clear myocardial infarction is suggested on the electrocardiogram, but not when there is no clear indication of myocardial infarction. Nonetheless, a relevant portion (more or less 40%) of the patients without a clearly abnormal electrocardiogram, still have an important problem in the blood vessels of the heart. We aim to determine whether the CT scan provides accurate information about the condition of the blood vessels of the heart. The CT scan was already well examined for this purpose before, but in the currently conventional way it needs preparation with extra monitoring and administration of medication, which would lead to loss of precious time and potentially dangerous side effects of these drugs in this critical situation. For that reason, a new software modality was developed that allows us to examine the coronary arteries in the same CT scan, without need for additional monitoring or medication administration. It does not need additional contrast administration (the dye necessary for optimal evaluation of some diseases). The goal of this study is to determine whether this new technique gives us the correct information about the coronary arteries. This means we acquire the images of the heart in the same scan, and verify the results with the conventional coronary angiography. If the technique provides accurate information, it could lead to a better selection of patients we need to urgently refer for a coronary angiography and to defer the exam in those who have normal coronary arteries on the scan.

Conditions

Cardiac Arrest (CA); Myocardial Infarction (MI)

Keywords

Cardiac Arrest; Myocardial Infarction; Coronary Computed Tomography Angiography (CCTA)

Outcome Measures

Primary Outcomes (1)

• Percentage of patients correctly classified to coronary artery disease as the cause of cardiac arrest after analysis of the CT scan

  With the invasive coronary angiography as a gold standard, the investigator will assess whether the CT scan correctly allocated the patient to coronary versus non coronary cause of cardiac arrest

  Withing 24 hours after completion of the coronary angiography (which is performed within 24 hours of the CT scan) the comparative analysis will be performed

Secondary Outcomes (17)

• Level of agreement on the estimated percentage of coronary artery stenosis between CCTA and ICA

  Withing 24 hours after completion of the coronary angiography (which is performed within 24 hours of the CT scan) the comparative analysis will be performed

• Feasibility of ECG-less gated CCTA in resuscitated patients

  Within 24 hours after completion of the coronary angiography (which is performed within 24 hours of the CT scan) the analysis will be performed

• Reasons for failure of ECG-less gated CCTA image acquisition

  Within 24 hours after completion of the coronary angiography (which is performed within 24 hours of the CT scan) the analysis will be performed

• Survival

  90 days after enrollment

• Severe neurologic deficit

  90 days after enrollment

Study Arms (1)

Cardiac arrest survivor without STEMI

EXPERIMENTAL

Survivor of a cardiac arrest without STEMI, meeting inclusion criteria and no exclusion criteria, with informed consent from either the patient or his/her representative.

Device: ECG-less gated cardiac CT

Interventions

ECG-less gated cardiac CT DEVICE

Perform ECG-less gated cardiac CT during the CT scan routinely executed after survival of cardiac arrest in patients without STEMI.

Cardiac arrest survivor without STEMI

Eligibility Criteria

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

You may qualify if:

• Adults (≥18 years) with sustained return of spontaneous circulation (ROSC) following in/out-of-hospital cardiac arrest.
• Informed consent from patient or representative obtained before invasive coronary angiography.
• Patients on VA-ECMO
• ACS STEMI or STEMI "equivalent"
• New left/right bundle branch block
• ST segment depression in leads V1-V3, when the terminal T wave is positive and concomitant ST-segment elevation ≥ 0,5mm recorded in leads V7-V9 (posterior MI)
• ST-segment elevation in V7-V9 (posterior MI) or V3R-V4R (RV MI)
• ACS NSTEMI with persistent ST depression despite optimal therapy, suggesting ongoing myocardial ischemia, with indication for an urgent ICA according to the treating physician.
• Hemodynamic/electrical instability precluding CT imaging (as perceived by the treating physician)
• Life-threatening arrhythmia potentially caused by acute myocardial ischemia
• Absolute contraindications to iodinated contrast
• Patients with a known non-cardiac cause of cardiac arrest (e.g., traumatic brain injury, overt hemorrhage, asphyxia/severe hypoxia due to known lung disease, trauma, severe metabolic/electrolyte derangement, or intoxication) as perceived by the treating physician, where chest CT is considered unnecessary.
• Known or likely pregnancy or lactation
• Severe bleeding issue (as perceived by the treating physician) precluding heparin administration during radial access coronary angiography.
• Prior coronary intervention (stent implantation/CABG).

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel (UZB)

Brussels, Vlaams Brabant, 1090, Belgium

RECRUITING

Related Publications (14)

• Meier D, Andreini D, Cosyns B, Skalidis I, Storozhenko T, Mahendiran T, Assanelli E, Sonck J, Roosens B, Rotzinger DC, Qanadli SD, Tzimas G, Muller O, De Bruyne B, Collet C, Fournier S. Usefulness of FFR-CT to exclude haemodynamically significant lesions in high-risk NSTE-ACS. EuroIntervention. 2025 Jan 6;21(1):73-81. doi: 10.4244/EIJ-D-24-00779.

  PMID: 39468963 RESULT

• Meijboom WB, Meijs MF, Schuijf JD, Cramer MJ, Mollet NR, van Mieghem CA, Nieman K, van Werkhoven JM, Pundziute G, Weustink AC, de Vos AM, Pugliese F, Rensing B, Jukema JW, Bax JJ, Prokop M, Doevendans PA, Hunink MG, Krestin GP, de Feyter PJ. Diagnostic accuracy of 64-slice computed tomography coronary angiography: a prospective, multicenter, multivendor study. J Am Coll Cardiol. 2008 Dec 16;52(25):2135-44. doi: 10.1016/j.jacc.2008.08.058.

  PMID: 19095130 RESULT

• Budoff MJ, Dowe D, Jollis JG, Gitter M, Sutherland J, Halamert E, Scherer M, Bellinger R, Martin A, Benton R, Delago A, Min JK. Diagnostic performance of 64-multidetector row coronary computed tomographic angiography for evaluation of coronary artery stenosis in individuals without known coronary artery disease: results from the prospective multicenter ACCURACY (Assessment by Coronary Computed Tomographic Angiography of Individuals Undergoing Invasive Coronary Angiography) trial. J Am Coll Cardiol. 2008 Nov 18;52(21):1724-32. doi: 10.1016/j.jacc.2008.07.031.

  PMID: 19007693 RESULT

• Voicu S, Sideris G, Deye N, Dillinger JG, Logeart D, Broche C, Vivien B, Brun PY, Capan DD, Manzo-Silberman S, Megarbane B, Baud FJ, Henry P. Role of cardiac troponin in the diagnosis of acute myocardial infarction in comatose patients resuscitated from out-of-hospital cardiac arrest. Resuscitation. 2012 Apr;83(4):452-8. doi: 10.1016/j.resuscitation.2011.10.008. Epub 2011 Oct 29.

  PMID: 22037386 RESULT

• Staer-Jensen H, Nakstad ER, Fossum E, Mangschau A, Eritsland J, Draegni T, Jacobsen D, Sunde K, Andersen GO. Post-Resuscitation ECG for Selection of Patients for Immediate Coronary Angiography in Out-of-Hospital Cardiac Arrest. Circ Cardiovasc Interv. 2015 Oct;8(10):e002784. doi: 10.1161/CIRCINTERVENTIONS.115.002784.

  PMID: 26453688 RESULT

• Sideris G, Voicu S, Dillinger JG, Stratiev V, Logeart D, Broche C, Vivien B, Brun PY, Deye N, Capan D, Aout M, Megarbane B, Baud FJ, Henry P. Value of post-resuscitation electrocardiogram in the diagnosis of acute myocardial infarction in out-of-hospital cardiac arrest patients. Resuscitation. 2011 Sep;82(9):1148-53. doi: 10.1016/j.resuscitation.2011.04.023. Epub 2011 May 14.

  PMID: 21632166 RESULT

• Lee SE, Uhm JS, Kim JY, Pak HN, Lee MH, Joung B. Combined ECG, Echocardiographic, and Biomarker Criteria for Diagnosing Acute Myocardial Infarction in Out-of-Hospital Cardiac Arrest Patients. Yonsei Med J. 2015 Jul;56(4):887-94. doi: 10.3349/ymj.2015.56.4.887.

  PMID: 26069108 RESULT

• Dumas F, Manzo-Silberman S, Fichet J, Mami Z, Zuber B, Vivien B, Chenevier-Gobeaux C, Varenne O, Empana JP, Pene F, Spaulding C, Cariou A. Can early cardiac troponin I measurement help to predict recent coronary occlusion in out-of-hospital cardiac arrest survivors? Crit Care Med. 2012 Jun;40(6):1777-84. doi: 10.1097/CCM.0b013e3182474d5e.

  PMID: 22488008 RESULT

• Gonzalez MR, Esposito EC, Leary M, Gaieski DF, Kolansky DM, Chang G, Becker LB, Carr BG, Grossestreuer AV, Abella BS. Initial clinical predictors of significant coronary lesions after resuscitation from cardiac arrest. Ther Hypothermia Temp Manag. 2012 Jun;2(2):73-7. doi: 10.1089/ther.2012.0012. Epub 2012 Jul 9.

  PMID: 24717160 RESULT

• Desch S, Freund A, Akin I, Behnes M, Preusch MR, Zelniker TA, Skurk C, Landmesser U, Graf T, Eitel I, Fuernau G, Haake H, Nordbeck P, Hammer F, Felix SB, Hassager C, Engstrom T, Fichtlscherer S, Ledwoch J, Lenk K, Joner M, Steiner S, Liebetrau C, Voigt I, Zeymer U, Brand M, Schmitz R, Horstkotte J, Jacobshagen C, Poss J, Abdel-Wahab M, Lurz P, Jobs A, de Waha-Thiele S, Olbrich D, Sandig F, Konig IR, Brett S, Vens M, Klinge K, Thiele H; TOMAHAWK Investigators. Angiography after Out-of-Hospital Cardiac Arrest without ST-Segment Elevation. N Engl J Med. 2021 Dec 30;385(27):2544-2553. doi: 10.1056/NEJMoa2101909. Epub 2021 Aug 29.

  PMID: 34459570 RESULT

• Elfwen L, Lagedal R, Nordberg P, James S, Oldgren J, Bohm F, Lundgren P, Rylander C, van der Linden J, Hollenberg J, Erlinge D, Cronberg T, Jensen U, Friberg H, Lilja G, Larsson IM, Wallin E, Rubertsson S, Svensson L. Direct or subacute coronary angiography in out-of-hospital cardiac arrest (DISCO)-An initial pilot-study of a randomized clinical trial. Resuscitation. 2019 Jun;139:253-261. doi: 10.1016/j.resuscitation.2019.04.027. Epub 2019 Apr 24.

  PMID: 31028826 RESULT

• Thevathasan T, Freund A, Spoormans E, Lemkes J, Rossberg M, Skurk C, Fichtlscherer S, Akin I, Fuernau G, Hassager C, Zeymer U, Preusch MR, Graf T, Jung C, Abdel-Wahab M, Jobs A, Laufs U, Schulze PC, Linke A, de Waha S, Poss J, Thiele H, Desch S. Bayesian Reanalyses of the Trials TOMAHAWK and COACT. JACC Cardiovasc Interv. 2024 Dec 23;17(24):2879-2889. doi: 10.1016/j.jcin.2024.09.071.

  PMID: 39722271 RESULT

• Lemkes JS, Janssens GN, van der Hoeven NW, Jewbali LSD, Dubois EA, Meuwissen M, Rijpstra TA, Bosker HA, Blans MJ, Bleeker GB, Baak R, Vlachojannis GJ, Eikemans BJW, van der Harst P, van der Horst ICC, Voskuil M, van der Heijden JJ, Beishuizen A, Stoel M, Camaro C, van der Hoeven H, Henriques JP, Vlaar APJ, Vink MA, van den Bogaard B, Heestermans TACM, de Ruijter W, Delnoij TSR, Crijns HJGM, Jessurun GAJ, Oemrawsingh PV, Gosselink MTM, Plomp K, Magro M, Elbers PWG, van de Ven PM, Oudemans-van Straaten HM, van Royen N. Coronary Angiography after Cardiac Arrest without ST-Segment Elevation. N Engl J Med. 2019 Apr 11;380(15):1397-1407. doi: 10.1056/NEJMoa1816897. Epub 2019 Mar 18.

  PMID: 30883057 RESULT

• ESC Scientific Document Group. [2022 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death]. G Ital Cardiol (Rome). 2023;24(3 Suppl 1):e1-e132. doi: 10.1714/3986.39669. No abstract available. Italian.

  PMID: 36880552 RESULT

MeSH Terms

Conditions

Heart Arrest; Myocardial Infarction

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The results of cardiac part of the CT scan will be masked for the clinician (as there is no sufficient validation of this technique in this specific clinical setting) and for the interventional cardiologist
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: October 15, 2025
• First Posted: February 5, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-01

Locations

BE (1)