How well can scars of the heart muscle be seen and measured when using a reduced contrast dose for MRI imaging of the heart?
| ISRCTN | ISRCTN40864982 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40864982 |
| Secondary identifying numbers | EA1/087/21 |
- Submission date
- 26/07/2021
- Registration date
- 20/09/2021
- Last edited
- 20/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aim:
Myocardial scar is scarring of the heart muscle that occurs after some form of injury to the heart muscle such as a myocardial infarction (heart attack) or inflammatory heart disease as well as inherited disease of the heart muscle. Myocardial scar can impact the ability of the heart to pump blood around the body. Imaging and assessment of scars and fibrosis, particularly in the left ventricle (the main left chamber of the heart), are essential components of routine clinical practice in Cardiovascular magnetic resonance (CMR).
The aim of this study is to investigate whether imaging and quantification of myocardial scar using reduced contrast dose in late-gadolinium enhancement technique is possible.
Who can participate?:
Patients with a confirmed or suspected diagnosis of acute or chronic myocardial infarction or inflammatory heart disease or hypertrophic cardiomyopathy and a clinically indicated cardiac MRI examination with gadolinium-containing contrast agent according to the disease present.
What does the study involve:
For participants in this study, the routine MRI examination will be expanded by 3-5 min to include additional sequences. This will allow MRI images to be collected that can be used by the study team to compare how well the myocardial scar can be measured after using different imaging techniques.
What are the possible benefits and risks of participating?:
If the imaging of myocardial scarring using reduced contrast dose in late-gadolinium enhancement technique is shown to be equal to routine imaging techniques, then patients who have not undergone an indicated contrast-enhanced cardiac MRI examination as part of their care so far, or only after a delay (for example patients with severe chronic renal failure or with acute renal failure), could benefit from the added value of this examination in terms of identifying disease and possibly improving outcomes.
There is a lack of evidence that gadolinium contrast deposits in the central nervous system cause disease, however, a reduced contrast agent burden for each patient could cause a significant reduction in the incidence of nephrogenic systemic fibrosis (NSF). NSF is a rare disorder that occurs in some individuals with reduced kidney function, who have been exposed to intravenous contrast material that contains gadolinium.
Shorter examination times may also reduce waiting times for an MRI examination or increase productivity per MRI scanner. Likewise, the time burden on individual patients can be reduced.
It is not expected that the study-related extension of the examination by 3-5 min in a total examination time of 30-45 min anyway poses an additional risk. Since participants would be indicated for the MRI examination and the administration of contrast medium regardless of participation in this study, there are no foreseeable study-related burdens or risks for the study participants.
Where is the study run from?
Helios Clinics Berlin Buch (Germany)
When is the study starting and how long is it expected to run for?
From November 2020 to December 2023
Who is funding the study?
Working group Cardiovascular Magnetic Resonance, Charité Berlin Buch (Germany)
Who is the main contact?
Maximilian Fenski
maximilian.fenski@charite.de
Contact information
Scientific
Lindenberger Weg 80
Berlin
13125
Germany
 ORCID ID |
0000-0002-5943-305X |
|---|---|
| Phone | +49 (0)1773186477 |
| maximilian.fenski@charite.de |
Study information
| Study design | Prospective cross-sectional single-center trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | 40212_PIS_German_v1.0_16Feb2021.pdf |
| Scientific title | Imaging and quantification of myocardial scars using reduced contrast dose in late-gadolinium enhancement technique by cardiovascular MRI (TWIN-CMR) |
| Study acronym | TWIN-CMR |
| Study objectives | True "full-dose" (reference standard) and synthetic full-dose imaging show a diagnostically equivalent result in terms of myocardial scar tissue mass. |
| Ethics approval(s) | Approved 19/05/2021, Charité Ethics Committee (Campus Berlin Mitte, Charitéplatz 1, 10117 Berlin, Germany; +49 030 450 517 266; no email contact available), ref: EA1/087/21 |
| Health condition(s) or problem(s) studied | Imaging and quantification of myocardial scars in patients with acute or chronic myocardial infarction, inflammatory heart disease, or hypertrophic cardiomyopathy |
| Intervention | The routine MRI examination will be expanded to include the following sequences: - T1-MOLLI- mapping short-axis images in breath-hold. - T1-MOLLI mapping short-axis acquisitions in free breathing. - Additional MOCO PSIR 2D LGE images in free respiration Use of an artificial neural network in the area of software post-processing of acquired MRI images. Here, T1 mapping and conventional LGE acquisitions are performed at different time points (before KM administration, after first administration of KM, and two acquisitions after second KM administration). By learning the pattern of T1 relaxation change over time with administration of lower doses of KM, an image impression (a so-called synthetic "full-dose recording") as achieved with higher doses of KM (true "full-dose recording") is potentially possible. |
| Intervention type | Other |
| Primary outcome measure | Scar mass measured using a semi-automatic thresholding-based approach (full width at half maximum) at a single timepoint (the time the MRI image was taken) |
| Secondary outcome measures | Synthetic full-dose recording performance compared to the reference standard measured by the signal-to-noise ratio and contrast-to-noise ratio of the MRI image at the single timepoint |
| Overall study start date | 01/11/2020 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 280 |
| Key inclusion criteria | 1. Written consent of the patient prior to commencement of study-specific actions 2. Capable of giving consent and capable of understanding the nature and scope of the clinical trial 3. Aged ≥18 years 4. Confirmed diagnosis or suspected diagnosis of acute or chronic myocardial infarction, inflammatory heart disease, or hypertrophic cardiomyopathy 5. Clinically indicated cardiac MRI examination with gadolinium-containing contrast agent according to the disease present |
| Key exclusion criteria | 1. Absolute contraindication to MRI examination (e.g. presence of metal implants, insulin pumps, pacemakers, ICDs, orbital foreign bodies, non-MRI cochlear implants, cerebral vascular clips) 2. Known allergy to MRI contrast media 3. Pregnant or breastfeeding 4. Have already participated in this study 5. Refusal to participate 6. Not capable of giving consent |
| Date of first enrolment | 01/06/2021 |
| Date of final enrolment | 31/12/2023 |
Locations
Countries of recruitment
- Germany
Study participating centre
Berlin
13125
Germany
Sponsor information
Hospital/treatment centre
Lindenberger Weg 80
Berlin
13125
Germany
| Phone | +49 30 450 553 749 |
|---|---|
| maximilian.fenski@charite.de | |
| Website | https://www.charite.de/en/ |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to state data protection regulations. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | German language version v1.0 |
16/02/2021 | 27/07/2021 | No | Yes |
| Protocol file | version MRI protocol | 27/07/2021 | 27/07/2021 | No | No |
Additional files
- 40212_Protocol_MRI.pdf
- 40212_PIS_German_v1.0_16Feb2021.pdf
- German language
Editorial Notes
27/07/2021: Trial’s existence confirmed by Charité Ethics Committee.
