Comparison of two different techniques to visualize narrowing of coronary arteries using cardiac MRI: the SPARSE perfusion study
| ISRCTN | ISRCTN59354874 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59354874 |
| Secondary identifying numbers | SPARSE perfusion (internal study code) |
- Submission date
- 15/03/2019
- Registration date
- 30/04/2019
- Last edited
- 10/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
Schwanebecker Chaussee 50
Berlin
13125
Germany
 ORCID ID |
0000-0002-7981-5178 |
|---|---|
| Phone | +4930940112988 |
| fabian.muehlberg@helios-gesundheit.de |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format |
| Scientific title | Comparison of compressed sensing-based gradient echo perfusion sequence and conventional gradient echo sequence in assessment of myocardial ischemia |
| Study acronym | SPARSE |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 05/01/2015 |
| Completion date | 31/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 25 |
| Total final enrolment | 23 |
| Key inclusion criteria | 1. Planned invasive coronary angiography due to clinical suspection of coronary artery disease 2. Age at least 18 years (no upper limit) |
| Key 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 |
| Date of first enrolment | 01/04/2015 |
| Date of final enrolment | 30/06/2016 |
Locations
Countries of recruitment
- Germany
Study participating centre
Berlin
13125
Germany
Sponsor information
University/education
Lindenberger Weg 80
Berlin
13125
Germany
| Phone | +4930940112988 |
|---|---|
| fabian.muehlberg@helios-gesundheit.de | |
"ROR" |
https://ror.org/05hgh1g19 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Medical School - Charité - University Medicine Berlin
- Location
- Germany
Results and Publications
| Intention to publish date | 30/09/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/10/2020 | 10/09/2021 | Yes | No |
Editorial Notes
10/09/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
18/03/2019: Trial’s existence confirmed by Ethics board at Charité University Medicine Berlin (Ethikkommission der Charité
