|- candidate number||19508|
|- NTR Number||NTR4865|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-sep-2014|
|- Secondary IDs||None available |
|- Public Title||MRI Flow Offset Correction Study|
|- Scientific Title||In-vivo validation of background offset correction in MRI phase contrast velocity acquisitions|
|- hypothesis||To validate in vivo the velocity offset correction method as published by Walker PG et al. (JMRI 3, 521 1993) such that it can assure velocity offsets < 0.6 cm/s at the ascending aorta and pulmonary artery for 2D through-plane phase contrast MRI velocity measurements at different centers and for different vendors.|
|- Healt Condition(s) or Problem(s) studied||MRI, Magnetic resonance imaging (MRI) |
|- Inclusion criteria||- Informed consent |
- Sinus rhythm at CMR examination
- 2D flow acquisitions by MRI at the aorta or pulmonary artery without spatial infolding artefacts.
- MRI acquisition on MRI system by Siemens: Magnetom Avanto, VB17 or newer 1.5 T systems such; for GE: Signa Excite (HDx 15M4) or newer as the Optima MR360; and for Philips: Achieva R2.6.3 or newer as the Ingenia.
- MRI flow acquisitions with the general accepted standard settings
|- Exclusion criteria||- Incapacitated adults.|
- Lack of a phantom measurement within the protocol specifications.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||28-jul-2014|
|- planned closingdate||1-mei-2015|
|- Target number of participants||120|
|- Interventions||Observational study. |
Seperate phantom measurements will be obtained after an in vivo clinical MRI scan.
|- Primary outcome||The primary study outcome parameter is the velocity offset in cm/s at the location of the aorta or pulmonary artery.|
|- Secondary outcome||- To describe the offset error over the systems included in the study|
- To test whether the static phantom offset corrections are valid, the difference between the velocity at the thorax wall and the phantom be assessed.
- The validity of offset corrections using higher order fitting, and the LPC filter.
|- Timepoints||There will an analysis at the end of the inclusion periode, at about 1 year.|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||PhD M.B.M. Hofman|
|- CONTACT for SCIENTIFIC QUERIES||PhD M.B.M. Hofman|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|VU University Medical Center|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||19-sep-2014 - 25-nov-2014|