Differences in the quantity of fluid detected in pleural and pericardial space by cardiovascular magnetic resonance between healthy subjects and subjects with inflammatory heart disease

ISRCTN	ISRCTN24808788
DOI	https://doi.org/10.1186/ISRCTN24808788
Secondary identifying numbers	SERO PRO (internal study protocol name)

Submission date: 17/07/2019
Registration date: 28/08/2019
Last edited: 08/02/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The appearance of a small amount of pericardial and pleural fluid (fluid around the heart and lungs) seems to be a frequent finding in routine cardiovascular magnetic resonance (CMR) scans. It seems to be related to inflammation, but data are conflicting. In routine CMR small pericardial and pleural effusion are detectable in patients who meet all CMR criteria for myocardial (heart muscle) inflammation as well as in patients without any signs of myocardial inflammation. The findings were detectable in healthy volunteers who were participating in other trials. Currently, no systemic analysis exists studying these effusions. The main aim of this study is to better understand the occurrence of pleural and pericardial effusions in healthy volunteers and in patients with suspected inflammatory heart disease, especially if the traditional CMR criteria of myocardial inflammation are only partially fulfilled. The other aims are to assess the potential impact of quantification of these effusions on decision making in suspected myocardial inflammation, and the changes of pericardial and pleural effusion in premenopausal women across the menstrual cycle.

Who can participate?
Patients with suspected inflammatory heart disease and healthy premenopausal women

What does the study involve?
Healthy premenopausal women are asked to undergo a clinical examination, blood sampling and CMR scan without contrast media twice during different phases of their menstrual cycle. Changes of pericardial and pleural effusion are assessed and a cut-off value for “normal” amounts of these fluids is established. Patients with suspected cardiac inflammation who require CMR examination are asked to participate, and if willing, CMR data and blood samples, as well as dedicated clinical data, are collected.

What are the possible benefits and risks of participating?
There is no direct benefit expected for the participants. A standard blood sample is collected and there are possible risks: infection, irritation and warming of the puncture site may occur.

Where is the study run from?
HELIOS Clinic Berlin-Buch (Germany)

When is the study starting and how long is it expected to run for?
April 2015 to December 2023

Who is funding the study?
Charité – Universitätsmedizin Berlin (Germany)

Who is the main contact?
1. Prof. Jeanette Schulz-Menger
jeanette.schulz-menger@charite.de
2. Dr Agnieszka Töpper
agnieszka.toepper@jsd.de

Contact information

Prof Jeanette Schulz-Menger
Scientific

Charité University Medicine Berlin
Campus Buch
Working Group Kardiale MRT
Lindenberger Weg 80
Berlin
13125
Germany

Phone	+49 (0)30 940152903
Email	jeanette.schulz-menger@charite.de

Dr Agnieszka Töpper
Scientific

Paul Gerhard Diakonie Krankenhaus und Pflege GmbH
Paul-Gerhard-Strasse 42-45
Lutherstadt Wittenberg
06886
Germany

Phone	+49 (0)3491503999
Email	agnieszka.toepper@jsd.de

Study information

Study design	Observational prospective cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Diagnostic
Scientific title	Prevalence and characteristics of pleural and pericardial fluid in subjects with and without myocardial inflammation as detected using cardiovascular magnetic resonance imaging
Study objectives	The study rationale is to analyze the frequency of occurrence of pleural and pericardial fluid deposits in humans and to get a better understanding of their relevance in cases of myocardial inflammatory disease.
Ethics approval(s)	Approved 02/03/2016, Ethics board at Charité University Medicine Berlin, Campus Mitte (Ethikkommission, Ethikausschuss 1 am Campus Charite -Mitte, Chariteplatz 1, 10117 Berlin; Tel: +49 (0)3045051722; Email: ethikkommission@charite.de), ref: EA1/054/16
Health condition(s) or problem(s) studied	Myocardial inflammatory disease
Intervention	1. Cardiac MRI scan to detect myocardial inflammation at the beginning of the study (with contrast media for patients, without contrast media for healthy subjects), second cardiac MRI scan for female subjects in accordance to the phase of the menstrual cycle, maximal two MRI examinations during the study 2. Blood sampling once during the study 3. Follow up – on the basis of a questionnaire form up to 5 years
Intervention type	Other
Primary outcome measure	1. Presence of pleural and pericardial fluid deposits assessed using cardiac MRI scan at the baseline examination 2. Markers of inflammation measured using laboratory tests (WBC and c-reactive protein, hs-troponin) and MRI (standard parameters of myocardial inflammation: edema, late and early gadolinium enhancement) at baseline
Secondary outcome measures	1. Presence of pleural and pericardial fluid deposits assessed using cardiac MRI scan in subjects without any sign of inflammation and in healthy subjects at baseline and in accordance to the phase of the menstrual cycle 2. The amount (measured in mililiters) of pleural and pericardial fluid detected by MRI in premenopausal women in different (follicular or luteal) phases of the menstrual cycle 3. Quantification (in milliliters) of small amounts of pleural and pericardial fluid by semiautomated threshold method in MRI DICOM data at luteal and follicular phase of menstrual cycle 4. Development of heart failure, hospitalizations for cardiovascular reasons, death, assessed using standard questionnaire form up to 5 years
Overall study start date	01/04/2015
Completion date	31/12/2023

Eligibility

Participant type(s)	Mixed
Age group	Adult
Sex	Both
Target number of participants	300
Key inclusion criteria	1. Patients with suspected inflammatory heart disease: Clinical indication for MR exam with late gadolinium enhancement 2. Healthy premenopausal women: MR exam without contrast media
Key exclusion criteria	1. Any contraindication for MR exam 2. Any known pericardial or pleural disease 3. Any known malignant disease in the last 5 years 4. Pregnancy
Date of first enrolment	03/02/2016
Date of final enrolment	28/02/2018

Locations

Countries of recruitment

Germany

Study participating centre

HELIOS Clinic Berlin-Buch

Schwanebecker Chaussee 50
Berlin
13125
Germany

Sponsor information

Charité University Medicine Berlin
University/education

Working Group Kardiale MRT
Lindenberger Weg 80
Berlin
13125
Germany

Phone	+49 (0)30450540917
Email	jeanette.schulz-menger@charite.de
Website	www.cmr-berlin.org
"ROR"	https://ror.org/001w7jn25

Funders

Funder type

University/education

Charité – Universitätsmedizin Berlin
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	01/09/2019
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Stored in repository
Publication and dissemination plan	Results of this study shall be published in a high-ranking peer-reviewed journal.
IPD sharing plan	Data stored in anonymized form: DICOM-Data from CMR examination, the analysis of the CMR DICOM data, laboratory and questionnaire data stored in a study repository „agcmrt“.

Editorial Notes

08/02/2023: The overall end date was changed from 28/02/2023 to 31/12/2023.
19/07/2019: Trial's existence confirmed by ethics committee.