ClinicalTrials.Veeva

Menu

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

U

Universitair Ziekenhuis Brussel

Status

Enrolling

Conditions

Cardiac Arrest (CA)
Myocardial Infarction (MI)

Treatments

Device: ECG-less gated cardiac CT

Study type

Interventional

Funder types

Other

Identifiers

NCT07388342
1432025000122

Details and patient eligibility

About

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.

Full description

Acute coronary syndrome (ACS) is the most important treatable cause of cardiac arrest. In contrast with cardiac arrest survivors with ST elevation myocardial infarction (STEMI), current guidelines do not recommend unselected/routine urgent invasive coronary angiography (ICA) in the patients with cardiac arrest without STEMI. This recommendation reflects existing evidence indicating that immediate invasive strategies may not confer significant benefit in this population and may even be harmful, while another ongoing randomized controlled trial is investigating this. Nevertheless, in COACT, a landmark trial investigating a strategy of immediate versus delayed coronary angiography in out-of-hospital cardiac arrest patients without STEMI, one or more culprit coronary lesions responsible for triggering cardiac arrest were identified in 40% of the total patient population. The question remains pertinent whether well selected cardiac arrest survivors without STEMI can benefit from early ICA. Yet, current available clinical tools fail to identify these patients. Markers such as clinical history, echocardiographic abnormalities, arrest rhythm (shockable/non-shockable), ECG changes other than ST-segment elevation and troponin levels lack sufficient sensitivity and specificity in a cardiac arrest setting for predicting ACS requiring intervention.

The diagnostic value of ECG-gated cardiac computed tomography angiography (CCTA) for detection of both acute and chronic coronary artery syndrome is well established, with recent evidence demonstrating the additional value of fractional flow reserve (FFR)-CT in ACS. Nonetheless, the need for ECG-gating remains a limitation.

Recently an ECG-less CCTA modality was developed, but its diagnostic accuracy is still under validation. ECG-less cardiac or coronary CT angiography (CCTA) allows cardiac imaging without requiring an ECG signal from the patient. Thus, it eliminates the steps associated with using a patient-attached ECG monitor: skin preparation, attaching the ECG leads, checking impedance, and confirming that the leads provide an adequate ECG signal to the scanning system. Therefore, workflow is optimized, which is critical in an emergency setting. In situations where it is difficult to attach the ECG leads, such as patients in a resuscitation setting who already have diagnostic ECG leads in place or other instrumentation, it is also advantageous that there is no need for an ECG signal.

Cardiac arrest patients without STEMI and with no evident non-cardiac cause generally undergo CT imaging of head and chest for evaluation of potential causes of cardiac arrest (e.g. pulmonary embolism, acute aortic dissection, intracranial hemorrhage). While ECG-gated CCTA is considered the optimal modality for non-invasive coronary imaging, ECG-less CCTA might offer a highly interesting alternative with the advantages mentioned earlier. Other benefits include no substantially longer scanning time, no need for additional contrast injection or administration of betablockers.

ECG-less Cardiac software is an FDA-approved cardiac scan mode that essentially utilizes existing CT system scan technology. The system uses a wide detector coverage of 160mm to provide full heart coverage and a fast gantry speed of 0.23 seconds per rotation to perform imaging in a single cardiac cycle. An estimate of the heart rhythm has to be provided, which is often readily available because emergency patients are already monitored. Based on the heart rhythm the scanner simulates an ECG signal. This simulated ECG signal provides virtual gating of the scan. The acquisition can be performed during a full heart cycle or three-quarters or half cycle, depending on how fast the heart rhythm is. The existing cardiac software options of SmartPhase (automated phase selection) and SnapShot Freeze 2 (optimized volume registration) amplify the quality of the images and correct for motion.

Patients are scanned using a Revolution Apex Elite system (GE Healthcare, Waukesha, WI -USA). The investigators use a hyperdrive pulmonary CT angiography (523mm/s with 0.28s/rotation gantry speed). After a short delay of a few seconds (5-12 sec), allowing the contrast to leave the pulmonary circulation, and enter the aorta and coronary arteries, a coronary CT angiography is performed within the same contrast bolus. No extra contrast is given to acquire the cardiac images. No intravenous beta-blocker nor sublingual nitroglycerin is administered.

The total added exam time (assessing heart rhythm, preparing the scan parameters, the delay time and the acquisition itself) is about one to two minutes.

The dose-length product (DLP) of the ECG-less cardiac scan depends on the duration of the scan time that is chosen. The average DLP is between 150 and 200 mGy.cm. The diagnostic reference level (DRL) as set by the Federal Agency for Nuclear Controle (FANC) for a coronary CT angiography is 300 mGy.cm.

The combined pulmonary CT angiography and ECG-less cardiac scan can be used to diagnose all the pathologies that can be assessed on a conventional pulmonary CT angiography scan (including, but not limited to, pneumonia, pleural fluid, pulmonary embolism, pulmonary infarct, pulmonary mass, pneumothorax, pericardial fluid, etc.) and provides extra diagnostic information about coronary artery disease.

In case the technique is well validated, future clinical questions could include whether ECG-less CCTA can help to identify a patient population of cardiac arrest survivors without STEMI that do benefit from early invasive coronary angiography and whether earlier treatment could improve outcome.

This study aims to investigate the feasibility and diagnostic accuracy of ECG-less gated CCTA in cardiac arrest survivors without STEMI, by means of agreement with ICA.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

  • Inclusion:

    • 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.
  • Exclusion

    • 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).

    • CT findings indicating a condition that precludes coronary angiography in the short term.

    • Patients with end-of-life care pathways.

    • Participation in another intervention study interfering with the research questions in OPEN CCT Arrest.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Cardiac arrest survivor without STEMI
Experimental group
Description:
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.
Treatment:
Device: ECG-less gated cardiac CT

Trial documents
2

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems