Viability Imaging in Volumetric Angiography (VIVA 1)
The primary objective of this study is twofold:
- To define inter-reader variability of myocardial viability imaging within the first pass and delayed enhancement cardiac CT perfusion imaging
- To evaluate DE CT image quality using a consensus DECT protocol
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Viability Imaging in Volumetric Angiography (VIVA 1): A Single Center Trial of the Detection of Delayed Hyperenhancement on CT Angiography|
- Inter-reader variability of myocardial viability [ Time Frame: day One ] [ Designated as safety issue: No ]
To define inter-reader variability of myocardial viability imaging within the first pass and delayed enhancement cardiac CT perfusion imaging, specifically:
- Per myocardial segment binary visual estimation of the presence/absence of contrast enhancement on either a first pass or 10-minute delayed CT scan.
- Myocardial enhancement (hyper and hypo-enhancement) will be evaluated using a binary assessment for estimation of the involved myocardial segments on delayed images. Regional wall motion will be assessed qualitatively using a 4 point scale: normal, hypokinetic, akinetic, dyskinetic.
- DE CT image quality [ Time Frame: day One ] [ Designated as safety issue: No ]To evaluate DE CT image quality using a consensus DECT protocol
- Scan and patient factors related to the image quality [ Time Frame: day One ] [ Designated as safety issue: No ]The secondary endpoint will be to describe the scan and patient factors related to the image quality on myocardial CT perfusion imaging
|Study Start Date:||June 2011|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Other: DE CT
The presence of myocardial scar using radionuclide or magnetic resonance imaging techniques indicates myocardial segments with a reduced likelihood of functional recovery following myocardial revascularization. Preliminary evidence suggests that multi-detector CT (MDCT) angiography also can detect irreversible myocardial scarring through the detection of regions of delayed hyperenhancement (DE) of the myocardium.1-4 However, existing studies have been performed in single centers, and the reproducibility, and impact of this modality on recovery of myocardial function is unknown. In this study, the investigators propose a single-center trial using a standardized MDCT DE protocol among patients scheduled for clinical cardiac CT with planned reoperative surgical. The primary endpoint will be characteristics of DE imaging of the myocardium including its inter-reader variability and factors associated with image quality. These findings will further our understanding of the role of DE MDCT for the detection of myocardial viability.