Plain English Summary
Background and study aims
Stress Perfusion imaging using magnetic resonance Imaging plays a major role in non-invasive detection of coronary artery disease (CAD). It has been established as a robust non-invasive diagnostic tool in patients with moderate probability for relevant coronary artery disease, i.e. due to chest pain or pathologic changes in the electrocardiogram. The specificity (approx. 80%) and sensitivity (approx. 90%) of adenosine stress Perfusion Imaging are comparably high when compared to other Methods such as stress echocardiography or single-Photon Emission computed tomography (SPECT), however, is limited by spatial and temporal Resolution. New Perfusion sequences utilize a different method for Image Acquisition and enable higher resolutions which might lead to further increase of sensitivity and specificity of this method.
In this prospective study, we aim to compare such a novel gradient echo-based perfusion sequence (SPARSE) and a conventional gradient echo sequence (TurboFLASH) with regard to diagnostic performance. Doing this we might be able to increase diagnostic accuracy of the adenosine-perfusion MR in the future.
Who can participate?
Adult patients with suspected coronary artery disease who are scheduled for coronary angiography.
What does the study involve?
All participants receive two heart MRI scans before their scheduled coronary angiography. Both MR scans are performed in a Standard Fashion with adenosine-perfusion Imaging and in each scan one of the two tested sequences is used.
What are the possible benefits and risks of participating?
Participants might benefit from better detection of coronary artery disease using MRI. During the MRI scan, participants receive a standard dose of contrast medium that in rare occasions can cause allergic reactions. However, there are no study-associated side effects that exceed those of a regular MRI scan.
Where is the study run from?
HELIOS Hospital Berlin-Buch (Germany)
When is the study starting and how long is it expected to run for?
April 2015 - December 2016
Who is funding the study?
The cost of this study will be funded by the research group itself through university-affiliated research grants. No external funding is needed.
Who is the main contact?
Dr Fabian Muehlberg
Fabian.muehlberg@helios-gesundheit.de
Trial website
Contact information
Type
Scientific
Primary contact
Dr Fabian Muehlberg
ORCID ID
http://orcid.org/0000-0002-7981-5178
Contact details
Schwanebecker Chaussee 50
Berlin
13125
Germany
+4930940112988
fabian.muehlberg@helios-gesundheit.de
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
SPARSE perfusion (internal study code)
Study information
Scientific title
Comparison of compressed sensing-based gradient echo perfusion sequence and conventional gradient echo sequence in assessment of myocardial ischemia
Acronym
SPARSE
Study hypothesis
Compressed sensing-based gradient echo perfusion sequence SPARSE is non-inferior to conventional gradient echo sequence with regard to visual perfusion assessment by two blinded readers
Ethics approval
Approved 31/03/2015, Ethics board at Charité University Medicine Berlin (Ethikkommission der Charité, Campus Charité Mitte, Charitéplatz 1, 10117 Berlin; +49-30-450517222; e-mail: ethikkommission@charite.de), ref: EA1/081/15
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
Condition
Coronary artery disease
Intervention
Participants receive two adenosine-stress myocardial MR scans (one for each tested perfusion sequence*) and a coronary angiography as reference standard within six weeks. On both MR scans, coronary perfusion is analyzed visually and by two semi-quantitative methods (upslope myocardial perfusion reserve and fermi deconvution model) in order to compare myocardial perfusion. Coronary angiography is used as a reference Standard, where any visual stenosis > 90% or fractional flow reserve < 0.75 is considered a hemodynamically significant stenosis.
* Compressed sensing-based gradient echo perfusion sequence AND conventional gradient echo sequence
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Detection of stenosis by visual assessment of myocardial perfusion by two blinded readers for each MR scan.
Secondary outcome measures
Semi-quantitative perfusion analysis for both MR scans using two methods: upslope myocardial perfusion reserve and fermi deconvution model
Overall trial start date
05/01/2015
Overall trial end date
31/12/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Planned invasive coronary angiography due to clinical suspection of coronary artery disease
2. Age at least 18 years (no upper limit)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
25
Participant exclusion criteria
1. Any contraindication for contrast-based MRI or adenosine
2. Chronic renal failure (glomerular filtration rate < 30ml/min)
3. Previous participation in this study
4. Persistent or permanent atrial fibrillation
5. Coronary Intervention within 30 days before study inclusion
6. Myocardial infarction within 6 months before inclusion
Recruitment start date
01/04/2015
Recruitment end date
30/06/2016
Locations
Countries of recruitment
Germany
Trial participating centre
HELIOS Hospital Berlin-Buch
Schwanebecker Chaussee 50
Berlin
13125
Germany
Sponsor information
Organisation
Working Group Cardiac MRI @ Charité University Medicine Berlin & HELIOS Hospital Berlin-Buch
Sponsor details
Lindenberger Weg 80
Berlin
13125
Germany
+4930940112988
fabian.muehlberg@helios-gesundheit.de
Sponsor type
University/education
Website
Funders
Funder type
Hospital/treatment centre
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
We are intending to publish at least one research article in a high-ranking peer-reviewed journal, such as JCMR (impact factor 6.5)
IPD sharing statement:
The datasets generated during and/or analysed during the current study are 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
30/09/2019
Participant level data
Not expected to be available
Basic results (scientific)
Publication list