Cardiac involvement in patients with inflammatory bowel disease assessed by cardiovascular magnetic resonance imaging (CMR)

ISRCTN	ISRCTN30941346
DOI	https://doi.org/10.1186/ISRCTN30941346
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	ePA 3000170
Sponsor	Charité - University Medicine Berlin
Funder	Charité – Universitätsmedizin Berlin

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Dr Maximilian Fenski
Scientific

ECRC Berlin Buch
Lindenberger Weg 80
Berlin
13125
Germany

Phone	+49 (0)1773186477
Email	maximilian.fenski@charite.de

Study information

Primary study design	Observational
Study design	Single-center observational case-control study
Secondary study design	Case-control study
Study type	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(s)	Diffuse or focal fibrosis measured using T1-Mapping, ECV, and late gadolinium enhancement MRI scans at baseline, 5 weeks, and 1 year
Key secondary outcome measure(s)	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
Completion date	01/04/2023

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Helios Clinics Berlin Buch

Helios Klinikum Berlin Buch
Schwanebecker Chaussee 50
Berlin
13125
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
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?
Results article		05/08/2024	06/08/2024	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file		15/09/2020	16/03/2021	No	No
Protocol file		15/09/2020	16/03/2021	No	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.