ECG-less CT angiogram for people with high-troponin chest pain
ECG-less Coronary Computed Tomography Angiography in the Management of Patients Presenting With High-troponin Chest Pain
This trial will test whether an ECG-less CT angiogram can quickly rule out life-threatening causes in people who come to the ER with chest pain and elevated troponin levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 230 (estimated) |
| Ages | 30 Years and up |
| Sex | All |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Jette) |
| Trial ID | NCT07192965 on ClinicalTrials.gov |
What this trial studies
This interventional protocol enrolls adults presenting to the emergency room with chest pain and elevated troponin and uses a single-contrast, non‑ECG-gated coronary CT angiography (CCTA) protocol with reduced radiation to image the coronary arteries and thoracic causes of pain. Results from the ECG-less CCTA will be compared to the standard invasive coronary angiography (ICA) for diagnostic accuracy (negative and positive predictive values) in patients considered at risk for NSTEMI. The trial also compares the prognostic predictive value of CCTA versus ICA while following current guideline-directed clinical management and making PCI decisions based on ICA, physiology, and intravascular imaging. If diagnostic and prognostic performance are similar, the approach could allow some patients to avoid invasive angiography and shorten ED stays.
Who should consider this trial
Good fit: Ideal candidates are adults ≥30 years presenting to the ER with chest pain and either ECG abnormalities or elevated/observe-pathway hs‑cTnT per inclusion thresholds, who are hemodynamically stable and meet renal and consent criteria.
Not a fit: Patients who need urgent invasive angiography (ST‑elevation, hemodynamic or electrical instability, refractory pain), or who have prior CABG/stents, atrial fibrillation, severe renal failure, or contrast allergy are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, ECG-less CCTA could safely identify patients with normal coronaries who can be discharged without invasive angiography, reducing procedural risks, contrast use, and time in the hospital.
How similar studies have performed: While CCTA has been used in chest pain settings and CT is established for PE/AAD, the specific use of ECG‑less, non‑gated CCTA for ACS diagnostic and prognostic purposes remains largely novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 30 years old * Admission at the ER with acute chest pain and at least one of the follow-ing: 1. ECG abnormality; 2. positive rule-in criteria according to the ESC guidelines (hs-cTnT ≥ 52 in at least one assay or 1h ∆ ≥ 5); 3. troponine value in the "observe pathway" (hs-cTnT ≥ 12 in at least one assay or 1h ∆ ≥ 3) AND a high clinical suspicion of MI. Exclusion Criteria: * Indication for urgent ICA (ST-elevation, hemodynamic or electric instabil-ity, refractory chest pain, mechanical complications) * eGFR \< 30 ml/min * Previous coronary stenting * Previous CABG * Recent ACS within 6 months * Known severely reduced ejection fraction (EF \< 30%) * Contrast allergy * Inability to provide informed consent * Limited life expectancy \< 2 years due to non-cardiac conditions * Pregnant and breast-feeding women * Known congenital heart disease * Atrial fibrillation
Where this trial is running
Jette
- Universitair Ziekenhuis Brussel — Jette, Belgium (Recruiting)
Study contacts
- Study coordinator: Francesco Giangiacomi, Medical Doctor
- Email: francesco.giangiacomi@uzbrussel.be
- Phone: 0039 3347165451
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.