Prognostic Value of Coronary CT Angiography in Patients With Non-ST-Segment Elevation Acute Coronary Syndromes.
Klaus F Kofoed, Thomas Engstrøm, Per E Sigvardsen...
https://pubmed.ncbi.nlm.nih.gov/33632478Actively Recruiting
Phase Not Applicable
Age: 30Years +
All Genders
ID07192965
ECG-less Coronary Computed Tomography Angiography for Patients With High-troponin Chest Pain in Emergency Care
Led by Universitair Ziekenhuis Brussel · Updated on 2025-09-25
230
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Chest pain is a common reason for emergency room visits and can result from a range of conditions, from mild musculoskeletal issues to serious diseases like aortic dissection, pulmonary embolism, and myocardial infarction. This trial evaluates a new ECG-less computed tomography angiography (CCTA) system called the Revolution Apex Elite to diagnose coronary artery disease (CAD) in patients with high troponin chest pain, comparing it to the current gold standard invasive coronary angiography (ICA). The study also looks at the ability of this new CT system to identify alternative diagnoses and predict outcomes like myocardial infarction, coronary revascularization, and cardiac death over 18 months. Participants undergo a non-ECG-gated CT scan using the Revolution Apex Elite system, which captures images of the pulmonary, aortic, and coronary arteries with a single contrast injection and without the need for ECG leads. This scan is fast, taking about 1–2 minutes, and uses advanced software to enhance image quality. After the CT scan, patients will have an invasive coronary angiography within 24 hours. Both patients and cardiologists are blinded to the CT results except when an alternative diagnosis is found. Treatment decisions follow current guidelines, including possible revascularization based on ICA findings. Throughout the study, patients will be assessed for CAD using both CT and ICA images, with image analysis done by blinded radiologists. Researchers will measure the accuracy of the new CT method in detecting obstructive and high-risk coronary disease and evaluate its predictive value for cardiac events over time. The study duration includes follow-up for up to 18 months to monitor outcomes like myocardial infarction and cardiac death. Safety and diagnostic results will guide future use of this non-invasive imaging technique in chest pain management.
CONDITIONS
Brief Title
ECG-less Coronary Computed Tomography Angiography in the Management of Patients Presenting With High-troponin Chest Pain
Who Can Participate
Age: 30Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 30 years or older
- Admission to the emergency room with acute chest pain
- Presence of at least one of the following: ECG abnormality, positive rule-in troponin criteria per ESC guidelines, or troponin in the observe pathway with high clinical suspicion of myocardial infarction
You will not qualify if you...
- Urgent need for invasive coronary angiography due to severe chest pain or instability
- Estimated glomerular filtration rate (eGFR) less than 30 ml/min
- Previous coronary stenting or coronary artery bypass graft (CABG)
- Recent acute coronary syndrome within 6 months
- Severely reduced heart function (ejection fraction less than 30%)
- Allergy to contrast agents
- Inability to provide informed consent
- Life expectancy less than 2 years due to non-cardiac conditions
- Pregnancy or breastfeeding
- Known congenital heart disease
- Atrial fibrillation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Single day
Participants undergo a non-ECG-gated coronary computed tomography angiography (CCTA) to evaluate coronary arteries, ascending aorta, and pulmonary arteries using a single contrast bolus without ECG leads. This non-invasive scan helps to exclude life-threatening conditions and provides diagnostic information.
1 visit (in-person)
Diagnostic Evaluation
Duration - Within 1 day after CCTA
Within 24 hours after the CCTA, participants undergo invasive coronary angiography (ICA) to confirm diagnosis and guide treatment decisions as per standard clinical guidelines.
1 visit (in-person)
Monitoring
Duration - Up to 12 weeks
Participants are monitored for clinical outcomes and the accuracy of the diagnostic procedures is assessed over time.
Follow-up visits as per clinical care
Trial Site Locations
Total: 1 location
1
Universitair Ziekenhuis Brussel
Jette, Belgium, 1090
Actively Recruiting
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Research Team
F
Francesco Giangiacomi, Medical Doctor
J
Jean François Argacha, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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Published Research Related To This Trial
Long-Term Clinical Impact of Coronary CT Angiography in Patients With Recent Acute-Onset Chest Pain: The Randomized Controlled CATCH Trial.
Jesper J Linde, Jens D Hove, Mathias Sørgaard...
https://pubmed.ncbi.nlm.nih.gov/26577263CT angiography for safe discharge of patients with possible acute coronary syndromes.
Harold I Litt, Constantine Gatsonis, Brad Snyder...
https://pubmed.ncbi.nlm.nih.gov/22449295Coronary CT angiography versus standard evaluation in acute chest pain.
Udo Hoffmann, Quynh A Truong, David A Schoenfeld...
https://pubmed.ncbi.nlm.nih.gov/22830462Comparing image quality of coronary CT angiography with and without ECG-gating in wide-detector CT.
Kun Wang, Yueqiao Zhang, Bin Chen...
https://pubmed.ncbi.nlm.nih.gov/40290191Coronary CT Angiography in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome.
Jesper J Linde, Henning Kelbæk, Thomas F Hansen...
https://pubmed.ncbi.nlm.nih.gov/32029126Usefulness of FFR-CT to exclude haemodynamically significant lesions in high-risk NSTE-ACS.
David Meier, Daniele Andreini, Bernard Cosyns...
https://pubmed.ncbi.nlm.nih.gov/39468963Early computed tomography coronary angiography in patients with suspected acute coronary syndrome: randomised controlled trial.
Alasdair J Gray, Carl Roobottom, Jason E Smith...
https://pubmed.ncbi.nlm.nih.gov/345881622023 ESC Guidelines for the management of acute coronary syndromes.
Robert A Byrne, Xavier Rossello, J J Coughlan...
https://pubmed.ncbi.nlm.nih.gov/37622654Coronary computed tomography angiography without ECG leads; A feasibility study.
Brian Thomsen, Ali Nabipoor, Sanaz Asadian...
https://pubmed.ncbi.nlm.nih.gov/40328582