Cardiac involvement in patients with inflammatory bowel disease assessed by cardiovascular magnetic resonance imaging (CMR)
| ISRCTN | ISRCTN30941346 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30941346 |
| Secondary identifying numbers | ePA 3000170 |
- Submission date
- 02/03/2021
- Registration date
- 16/03/2021
- Last edited
- 06/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Patients with inflammatory bowel disease are at increased risk for adverse cardiovascular events, especially during active inflammatory bowel disease. Currently, there are not studies examining the underlying causes of this risk.
The study aims to assess abnormalities in the heart of patients with inflammatory bowel disease using a cardiovascular MRI scan (CMR-imaging).
Who can participate?
Patients who are 18 years or older, with a confirmed IBD diagnosis, who are able to provide informed consent, are not pregnant and are able to undergo CMR-imaging.
What does the study involve?
Participants will undergo a first CMR-imaging. Patients with signs of active inflammation will receive a second CMR scan after 5 weeks. A clinical follow-up is obtained 1 year after the first CMR scan.
What are the possible benefits and risks of participating?
In order to achieve study aims, the study team will characterise the tissue of the heart (obtained non-invasively) and therefore potentially identify patients at risk for adverse cardiovascular events. The risks of participating in this study are the usual risks associated with CMR-imaging and participants are not exposed to further risks.
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 April 2021 to April 2023
Who is funding the study?
Charité – Universitätsmedizin Berlin (Germany)
Who is the main contact?
Dr Maximilian Fenski, maximilian.fenski@charite.de
Contact information
Scientific
ECRC Berlin Buch
Lindenberger Weg 80
Berlin
13125
Germany
| Phone | +49 (0)1773186477 |
|---|---|
| maximilian.fenski@charite.de |
Study information
| Study design | Single-center observational case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Potential CArdiac MAanifestation in patients with Inflammatory bowel Disease in acute and chronic stage assessed by Cardiovascular Magnetic Resonance imaging (CAMAID-CMR) |
| Study acronym | CAMAID-CMR |
| Study objectives | A significantly higher degree of diffuse or focal fibrosis, assessed by CMR, can be found in patients with inflammatory bowel disease compared to an age and sex-matched healthy control group, despite preserved LV-EF |
| Ethics approval(s) | Approved 08/10/2020, Charité Ethics Board Berlin (Campus Charité Mitte (CCM), Chariteplatz 1, 10117 Berlin, German; +49 (0)30/450-517222; ethikkommission@charite.de), ref: EA1/198/20 |
| Health condition(s) or problem(s) studied | Patients with inflammatory bowel disease in acute and chronic stage |
| Intervention | Participants are categorized into acute or chronic stage based on IBD activity scores (Crohn's Disease Activity Index and Simple Clinical Colitis Activity Index). Each participant receives a CMR scan including LV and RV function, T1- and T2-Mapping, and fat and fibrosis assessments. Patients with signs of active inflammation will receive a second CMR scan after 5 weeks. A clinical follow-up is obtained 1 year after the first CMR scan. |
| Intervention type | Other |
| Primary outcome measure | Diffuse or focal fibrosis measured using T1-Mapping, ECV, and late gadolinium enhancement MRI scans at baseline, 5 weeks, and 1 year |
| Secondary outcome measures | 1. Ventricular function measured using MRI cine imaging at baseline, 5 weeks, and 1 year 2. Edema quantification using T2-Mapping MRI scans at baseline, 5 weeks, and 1 year 3. Extracellular volume quantification using T1-Mapping post-contrast agent application MRI scans at baseline, 5 weeks, and 1 year |
| Overall study start date | 01/04/2021 |
| Completion date | 01/04/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 44 |
| Key inclusion criteria | 1. Aged >18 years 2. Clinically, radiologically, and histologically confirmed diagnosis of inflammatory bowel disease 3. No absolute MRI contraindications 4. Able to provide informed consent |
| Key exclusion criteria | 1. Contraindications for MRI scan 2. Pregnancy 3. Known allergy to MRI contrast agent |
| Date of first enrolment | 01/04/2021 |
| Date of final enrolment | 01/04/2023 |
Locations
Countries of recruitment
- Germany
Study participating centre
Schwanebecker Chaussee 50
Berlin
13125
Germany
Sponsor information
Hospital/treatment centre
Charité Campus Berlin Buch
ECRC Experimental and Clinical Research Center
Lindenberger Weg 80
Berlin
13125
Germany
| Phone | +49 30 450 - 50 |
|---|---|
| maximilian.fenski@charite.de | |
| Website | https://www.charite.de/en/ |
"ROR" |
https://ror.org/001w7jn25 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Medical School - Charité - University Medicine Berlin
- Location
- Germany
Results and Publications
| Intention to publish date | 01/04/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 15/09/2020 | 16/03/2021 | No | No | |
| Protocol file | 15/09/2020 | 16/03/2021 | No | No | |
| Results article | 05/08/2024 | 06/08/2024 | Yes | No |
Additional files
- ISRCTN30941346_PROTOCOL_15Sept2020.pdf
- uploaded 16/03/2021
- ISRCTN30941346_PROTOCOL_MRI_15Sept2020.pdf
- uploaded 16/03/2021
Editorial Notes
06/08/2024: Publication reference and total final enrolment added.
16/03/2021: Uploaded protocols (not peer-reviewed) as additional files. Version n/a, 15 September 2020.
04/03/2021: Trial’s existence confirmed by Charité Ethics Board Berlin.
