Diagnostic Performance of Photon Counting Computed Tomography in High-Risk Patients With Acute Coronary Syndrome Without ST-segment Elevation

Diagnostic Performance of Photon Counting Computed Tomography in High-Risk Patients With Acute Coronary Syndrome Without ST-segment Elevation - PCCT in NSTE-ACS patients

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57442

Enrollment

206

Registered

2024-07-01

Start date

2025-05-13

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronary artery disease myocardial infarction NSTE-ACS myocardial infarction, NSTE-ACS, coronary artery disease

Interventions

This study uses Photon Counting CT (PCCT), an advanced CT imaging technique. During this scan, intravenous contrast is administered to visualize the coronary arteries. The estimated effective radiatio

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with high-risk NSTE-ACS, defined as:acute chest pain,electrocardiogram (ECG) without ST-elevation,high sensitivity troponin (hsTn) elevation (3x above the limit, rise and fall) or no/low hsTn + history of CABG and/or PCI,planned ICA within 24 hours after diagnosis or referral (from regional hospitals).

Exclusion criteria

Exclusion criteria: - low risk and very high risk NSTE-ACS (Acute Coronary Syndrome without ST-segment Elevation), - severe kidney dysfunction (eGFR

Design outcomes

Primary

Measure	Time frame
The diagnostic accuracy of PCCT (±FFRct) for the diagnosis of (hemodynamically) obstructive CAD compared to the reference standard, ICA (±FFRinv).	—

Secondary

Measure	Time frame
- Percentage (%) of NSTE-ACS patients approached to participate in the study that receive PCCT and ICA within the predefined time frame; - Agreement of revascularization decision and strategy based on PCCT (±FFRct) as compared to ICA (±FFRinv); - Radiation exposure (mSv), volume of contrast (ml), complication rate (%) for PCCT and ICA; - Agreement of PCCT in assessing plaque volume (total and by plaque component), and high-risk features as compared to IVUS and/or OCT.	—

Measure

Time frame

- Percentage (%) of NSTE-ACS patients approached to participate in the study that receive PCCT and ICA within the predefined time frame; - Agreement of revascularization decision and strategy based on PCCT (±FFRct) as compared to ICA (±FFRinv); - Radiation exposure (mSv), volume of contrast (ml), complication rate (%) for PCCT and ICA; - Agreement of PCCT in assessing plaque volume (total and by plaque component), and high-risk features as compared to IVUS and/or OCT.

—

Countries

Netherlands

Contacts

Public ContactE Lipsic

Universitair Medisch Centrum Groningen

e.lipsic@umcg.nl+31 50 361 6161

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 9, 2026