Evaluation of a new 3D cardiac MRI sequence for the identification of myocardial scars and fibrosis

Delineation of myocardial scar or fibrosis with high spatial resolution by means of cardiac MRI – validation and application of a 3-dimensional compressed sensing (3DCS) sequence

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN16766375

Enrollment

130

Registered

2021-04-20

Start date

2018-08-01

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Myocardial scarring and fibrosis and its role in cardiovascular risk stratification Circulatory System

Interventions

Patients recruited for this study will undergo in addition to their clinical cardiac MRI examination one additional image acquisition sequence (3DCS LGE). 1. Data quality, scar size, scar localizati

prospective assessment of the ability of risk stratification by scar size for the (re-)occurrence of arrhythmias (“survival”/Kaplan-Meier estimates). 3. Investigation of the sensitivity and specificit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Referral for cardiac MRI with clinical indication: 1. Existence of scar due to myocardial infarction or fibrosis due to myocarditis 2. (Paroxysmal) atrial fibrillation and referral for first pulmonary vein isolation; referral for the evaluation of A(RV)C 3. LAA thrombus and indication for cardiac MRI

Exclusion criteria

Exclusion criteria: Relative and absolute contraindication for (cardiac) MRI

Design outcomes

Primary

Measure	Time frame
1. Image quality of the LGE images (short axis [SAX] package, 2D gold standard and 3DCS) visually assessed using a 4-point Likert scale at baseline 2. Scar/fibrosis volume or weight (ml or g) and fraction of the overall myocardial mass (in %) measured by means of manual segmentation of images of the "gold standard" sequence and images from a new 3DCS sequence at baseline 3. Signal/contrast-to-noise ratios estimated by means of manual selection of voxels representing myocardium, scar and blood pool, measured at baseline 4. Scar identified/segmented manually and automatically using (1) for LV: cvi42 with manual segmentation of endocardial/epicardial contours in the SAX images and (a) “full width half maximum” calculation relative to ischemic scar areas or (cf. Flett et al. 2011, JACC: CVI; doi: 10.1016/j.jcmg.2010.11.015) or (b) identification of myocarditis-scars by identifying areas of myocardium with higher signal intensity than 3 standard deviations from the distribution of signal intensities of normal myocardium (cf. Mühlberg et al. 2018, JCMR; doi: 10.1186/s12968-018-0434-2); and (2) using methods for automatic LA-segmentation and fibrosis-detection as described in Razeghi et al. 2020 (doi: 10.1016/j.softx.2020.100570) at baseline 5. Time to occurrence and frequency of occurrence of arrhythmias assessed using ECG documentation and Holter monitoring at 3 months and 6 months after baseline 6. Existence or absence of thrombus in the LAA assessed via visual inspection of the acquired images at baseline	—

Measure

Time frame

1. Image quality of the LGE images (short axis [SAX] package, 2D gold standard and 3DCS) visually assessed using a 4-point Likert scale at baseline 2. Scar/fibrosis volume or weight (ml or g) and fraction of the overall myocardial mass (in %) measured by means of manual segmentation of images of the "gold standard" sequence and images from a new 3DCS sequence at baseline 3. Signal/contrast-to-noise ratios estimated by means of manual selection of voxels representing myocardium, scar and blood pool, measured at baseline 4. Scar identified/segmented manually and automatically using (1) for LV: cvi42 with manual segmentation of endocardial/epicardial contours in the SAX images and (a) “full width half maximum” calculation relative to ischemic scar areas or (cf. Flett et al. 2011, JACC: CVI; doi: 10.1016/j.jcmg.2010.11.015) or (b) identification of myocarditis-scars by identifying areas of myocardium with higher signal intensity than 3 standard deviations from the distribution of signal intensities of normal myocardium (cf. Mühlberg et al. 2018, JCMR; doi: 10.1186/s12968-018-0434-2); and (2) using methods for automatic LA-segmentation and fibrosis-detection as described in Razeghi et al. 2020 (doi: 10.1016/j.softx.2020.100570) at baseline 5. Time to occurrence and frequency of occurrence of arrhythmias assessed using ECG documentation and Holter monitoring at 3 months and 6 months after baseline 6. Existence or absence of thrombus in the LAA assessed via visual inspection of the acquired images at baseline

—

Secondary

Measure	Time frame
1. Acquisition time for the new 3DCS sequence measured using the timestamps of the MR sequences (in sec) at baseline 2. Region-specific analyses of scar quantification and region-specific analysis of signal/contrast-to-noise ratios in the LV conducted using the above-mentioned scar quantification methods with subdividing the myocardium of the LV into six circular segments referenced to the anterior RV-insertion and three longitudinal segments (basal, midventricular, apical) at baseline 3. Long-term follow up of the occurrence of arrhythmias using ECG documentation and Holter monitoring after 1 year	—

Measure

Time frame

1. Acquisition time for the new 3DCS sequence measured using the timestamps of the MR sequences (in sec) at baseline 2. Region-specific analyses of scar quantification and region-specific analysis of signal/contrast-to-noise ratios in the LV conducted using the above-mentioned scar quantification methods with subdividing the myocardium of the LV into six circular segments referenced to the anterior RV-insertion and three longitudinal segments (basal, midventricular, apical) at baseline 3. Long-term follow up of the occurrence of arrhythmias using ECG documentation and Holter monitoring after 1 year

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 27, 2026