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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01408134
|United States, District of Columbia|
|Washington Hospital Center|
|Washington, District of Columbia, United States, 20010|