Plain English Summary
Background and study aims
A cardiac MRI scan is a non-invasive test where magnetic and radio waves are used to create pictures of the inside of the heart. Over the last couple of years cardiac MRI has become the gold standard method for looking at scars in the heart muscle. This scarring can be due to myocardial infarction (heart attack), thickening of the heart walls or inflammation of the heart muscle itself and is a very strong indicator of the likely course of these conditions. Cardiac MRI uses a technique called late gadolinium enhancement (LGE) to show scars. The gold standard LGE technique is a so-called segmented PSIR sequence and provides great image quality, but only in patients with a stable heart rhythm and able to hold their breath, which is required for the technique to work. Unfortunately, many patients do not meet these requirements. New so-called multi-slice LGE sequences are faster techniques than the gold standard method and also work for patients with irregular heart rhythm or shortness of breath. The aim of this study is to assess the accuracy of three of these novel multi-slice LGE sequences to detect and quantify scars in the heart muscle when compared to a gold standard PSIR sequence.
Who can participate?
Patients aged 18 and over referred for cardiac MRI after a heart attack (myocardial infarction), with thickened heart walls (hypertrophic cardiomyopathies), or due to suspected or known inflammation of the heart muscle cells
What does the study involve?
All participants undergo a standard cardiac MRI scan with the gold standard LGE PSIR sequence and also the new multi-slice sequences. This prolongs the MRI scan by about five minutes. The size of the myocardium (heart muscle) and image quality are compared between the scans.
What are the possible benefits and risks of participating?
Possible benefits include improved detection of scars in the heart muscle. If the multi-slice sequences are found to perform as well as the gold standard sequence, these faster sequences could be used in future to improve access to cardiac MRI by decreasing scan time at a high image quality and increasing patient comfort. As all patients receive the cardiac MRI even if they do not participate and the scan itself is only prolonged by 5 minutes (of a 45 minutes total scan time), there is no additional risk or burden expected with participation in this study.
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?
November 2014 to December 2016
Who is funding the study?
Charité Universitätsmedizin Berlin (Germany)
Who is the main contact?
Prof. Jeanette Schulz-Menger
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LGE COMPARE (internal study code)
Study information
Scientific title
Comparison of fast multi-slice and standard segmented techniques for detection of late gadolinium enhancement in ischemic and non-ischemic cardiomyopathy - a prospective clinical trial
Acronym
Study hypothesis
All tested fast multi-slice LGE sequences are non-inferior to the segmented PSIR gold standard method with regard to LGE size quantification (in gram) using a semi-automated threshold method.
Ethics approval
Ethics board at Charité University Medicine Berlin, Campus Mitte, 16/10/2014, ref: EA1/305/14
Study design
Observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Myocardial infarction, hypertrophic cardiomyopathy and inflammatory heart disease
Intervention
This is an observational study in which three different techniques are compared for visualization of myocardial fibrosis using late Gadolinium enhancement in patients with known or suspected cardiomyopathy.
Patients sent for clinically indicated cardiac LGE-based MRI with known or suspected LGE due to chronic infarction, inflammatory myocardial disease and hypertrophic cardiomyopathy (HCM) are prospectively recruited. The indication for the MRI itself is clinical. However, for this study the MRI protocol is extended by the tested multislice LGE sequences for approximately 5 extra minutes. LGE images are acquired using three different LGE sequences. All patients were scanned with all three LGE sequences (intraindividual comparison). All LGE sequences are then assessed as follows: image quality is evaluated with a 4-point scoring system. Contrast-to-noise ratios and acquisition time are measured. Size of LGE is quantitatively assessed using a semi-automated threshold method. All assessments are done by blinded readers.
Intervention type
Other
Phase
Drug names
Primary outcome measures
Size of myocardium with late Gadolinium enhancement in each tested MR sequence, measured by semiautomated threshold method in MRI DICOM data at one timepoint, the date of the MRI (no follow up)
Secondary outcome measures
1. Contrast-to-noise ratio in each tested MR sequence, measured using MRI DICOM data
2. Image quality, scored on a 4-point-scaling system based on visual assessment by blinded readers
Measured at at one timepoint, the date of the MRI (no follow up)
Overall trial start date
01/11/2014
Overall trial end date
31/12/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Known or suspected chronic myocardial infarction, hypertrophic cardiomyopathy or inflammatory heart disease
2. Clinical indication for MR exam with late gadolinium enhancement
3. Age range ≥18 years (no upper limit)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
302
Participant exclusion criteria
1. Any contraindication for MR exam
2. Acute or chronic renal failure with GFR <30ml/min
Recruitment start date
01/11/2014
Recruitment end date
31/10/2016
Locations
Countries of recruitment
Germany
Trial participating centre
HELIOS Clinic Berlin-Buch
13125
Sponsor information
Organisation
Charité University Medicine Berlin
Sponsor details
Working Group Kardiale MRT
Lindenberger Weg 80
Berlin
13125
Germany
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
The datasets generated during and/or analysed during the current study is not expected to be made available due to reasons of data protection laws in Germany. However, upon request methodology and data set structure can be shared.
Intention to publish date
31/12/2017
Participant level data
Not expected to be available
Results - basic reporting
Publication summary