Viability Imaging in Volumetric Angiography (VIVA 1)

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Myocardial Scarring

Intervention / Treatment
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* Other: DE CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible patients will be adults, ages 18 and above with: Known CAD with prior MI based upon clinical history or electrocardiographic criteria Planned redo-surgical myocardial revascularization Referred for CT (and eligible) for pre-op substernal mapping/coronary artery evaluation Exclusion Criteria: Inability to provide informed consent Allergy to iodinated contrast media (unless pre-medicated with medical prophylaxis) Chronic kidney disease manifested by a serum creatinine >1.5 mg/dL, an estimated creatinine clearance <50 ml/kg/min or on dialysis Currently reporting or evaluated in NYHA class IV heart failure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: DE 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-reader variability of myocardial viability | 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. | day One | 
| DE CT image quality | To evaluate DE CT image quality using a consensus DECT protocol | day One | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scan and patient factors related to the image quality | The secondary endpoint will be to describe the scan and patient factors related to the image quality on myocardial CT perfusion imaging | day One | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inter-reader variability of myocardial viability imaging