Plain English Summary
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 February 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
Trial website
Contact information
Type
Scientific
Primary contact
Prof Jeanette Schulz-Menger
ORCID ID
Contact details
Charité University Medicine Berlin
Campus Buch
Working Group Kardiale MRT
Lindenberger Weg 80
Berlin
13125
Germany
+49 (0)30 940152903
jeanette.schulz-menger@charite.de
Type
Scientific
Additional contact
Dr Agnieszka Töpper
ORCID ID
Contact details
Paul Gerhard Diakonie Krankenhaus und Pflege GmbH
Paul-Gerhard-Strasse 42-45
Lutherstadt Wittenberg
06886
Germany
+49 (0)3491503999
agnieszka.toepper@jsd.de
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
SERO PRO (internal study protocol name)
Study information
Scientific title
Prevalence and characteristics of pleural and pericardial fluid in subjects with and without myocardial inflammation as detected using cardiovascular magnetic resonance imaging
Acronym
Study hypothesis
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
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
Study design
Observational prospective cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
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
Phase
Drug names
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 trial start date
01/04/2015
Overall trial end date
28/02/2023
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
300
Participant 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
Recruitment start date
03/02/2016
Recruitment end date
28/02/2018
Locations
Countries of recruitment
Germany
Trial participating centre
HELIOS Clinic Berlin-Buch
Schwanebecker Chaussee 50
Berlin
13125
Germany
Sponsor information
Organisation
Charité University Medicine Berlin
Sponsor details
Working Group Kardiale MRT
Lindenberger Weg 80
Berlin
13125
Germany
+49 (0)30450540917
jeanette.schulz-menger@charite.de
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Charité – Universitätsmedizin Berlin
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
Germany
Results and Publications
Publication and dissemination plan
Results of this study shall be published in a high-ranking peer-reviewed journal.
IPD sharing statement
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“.
Intention to publish date
01/09/2019
Participant level data
Stored in repository
Basic results (scientific)
Publication list