Skip to content

Viability Imaging in Volumetric Angiography (VIVA 1)

Viability Imaging in Volumetric Angiography (VIVA 1): A Single Center Trial of the Detection of Delayed Hyperenhancement on CT Angiography

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01408134
Acronym
VIVA 1
Enrollment
10
Registered
2011-08-03
Start date
2011-06-30
Completion date
2013-02-28
Last updated
2013-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Scarring

Keywords

Inter-reader variability of myocardial viability imaging

Brief summary

The primary objective of this study is twofold: 1. To define inter-reader variability of myocardial viability imaging within the first pass and delayed enhancement cardiac CT perfusion imaging 2. To evaluate DE CT image quality using a consensus DECT protocol

Detailed description

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.

Interventions

OTHERDE CT

Delayed scan (per VIVA protocol): The delayed scan will be performed 10 minutes after contrast second contrast bolus complete using axial acquisition at 100 kVp. Scan length will be limited to the cardiac structures.

Sponsors

Medstar Health Research Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Eligible patients will be adults, ages 18 and above with: 1. Known CAD with prior MI based upon clinical history or electrocardiographic criteria 2. Planned redo-surgical myocardial revascularization 3. Referred for CT (and eligible) for pre-op substernal mapping/coronary artery evaluation

Exclusion criteria

1. Inability to provide informed consent 2. Allergy to iodinated contrast media (unless pre-medicated with medical prophylaxis) 3. Chronic kidney disease manifested by a serum creatinine \>1.5 mg/dL, an estimated creatinine clearance \<50 ml/kg/min or on dialysis 4. Currently reporting or evaluated in NYHA class IV heart failure

Design outcomes

Primary

MeasureTime frameDescription
Inter-reader variability of myocardial viabilityday OneTo 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 qualityday OneTo evaluate DE CT image quality using a consensus DECT protocol

Secondary

MeasureTime frameDescription
Scan and patient factors related to the image qualityday OneThe secondary endpoint will be to describe the scan and patient factors related to the image quality on myocardial CT perfusion imaging

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026