Condition category
Circulatory System
Date applied
17/07/2019
Date assigned
28/08/2019
Last edited
28/08/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

www.cmr-berlin.org

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

Publication citations

Additional files

Editorial Notes

19/07/2019: Trial's existence confirmed by ethics committee.