Condition category
Circulatory System
Date applied
06/06/2017
Date assigned
10/07/2017
Last edited
10/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

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

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 measure

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 (if study stopped)

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

http://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
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

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes