The diagnostic and prognostic value of late enhancement photon-counting CT in patients with suspected myocardial fibrosis

The diagnostic and prognostic value of late enhancement photon-counting CT in patients with suspected myocardial fibrosis - 2ILLUMINATE

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57804

Enrollment

Registered

2025-06-18

Start date

2025-12-24

Completion date

Unknown

Last updated

2026-01-27

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

Conditions

myocardial fibrosis myocardial scar

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible for inclusion in group 1 of this study, a subject must meet all of the following criteria: - Age between 18-80 years old - Diagnosed with HFrEF de novo, defined as heart failure with an echocardiographic LVEF of 50%) is ruled out with angiography and no clinically overt specific cause for the acute presentation is present - Clinically referred for CMR imaging In order to be eligible for inclusion in group 3 of this study, a subject must meet all of the following criteria: - Age between 18-80 years old - Recent CMR in workup highly suggestive of myocarditis based on the Lake Louise criteria

Exclusion criteria

Exclusion criteria: - Logistics: Inability to organize CT shortly (before or) after the CMR scan - Safety: Pregnancy or breast-feeding - Safety: Renal failure (estimated Glomerular Filtration Rate (eGFR)

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the detection of myocardial fibrosis using PCD-CT LE in patients with HFrEF de novo, MINOCA, and myocarditis.	—

Secondary

Measure	Time frame
Secondary objectives for all groups: - The diagnostic accuracy of PCD-CT LE in detecting myocardial fibrosis in comparison with CMR LE as the reference standard. - To correlate ECV measurements obtained through PCD-CT with CMR ECV measurements. - To correlate the distribution and extent of myocardial fibrosis visualised with PCD-CT LE imaging with LE-CMR. - To investigate the feasibility of PCD-CT to combine LE imaging with coronary angiography in a single scan protocol. - To investigate the evolution of myocardial fibrosis after one year as visualised with PCD-CT LE imaging, in group 2 and 3 in comparison with LE CMR. Secondary objectives specifically for group 1 and 2: - The diagnostic accuracy of PCD-CT LE in differentiating between an ischemic and non-ischemic etiology of HFrEF and MINOCA, in comparison with CMR LE.	—

Measure

Time frame

Secondary objectives for all groups: - The diagnostic accuracy of PCD-CT LE in detecting myocardial fibrosis in comparison with CMR LE as the reference standard. - To correlate ECV measurements obtained through PCD-CT with CMR ECV measurements. - To correlate the distribution and extent of myocardial fibrosis visualised with PCD-CT LE imaging with LE-CMR. - To investigate the feasibility of PCD-CT to combine LE imaging with coronary angiography in a single scan protocol. - To investigate the evolution of myocardial fibrosis after one year as visualised with PCD-CT LE imaging, in group 2 and 3 in comparison with LE CMR. Secondary objectives specifically for group 1 and 2: - The diagnostic accuracy of PCD-CT LE in differentiating between an ischemic and non-ischemic etiology of HFrEF and MINOCA, in comparison with CMR LE.

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Countries

Netherlands

Outcome results