Viability Imaging in Volumetric Angiography (VIVA 1)

Medstar Health Research Institute10 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Myocardial Scarring

Interventions

DE CTOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Washington Hospital Center

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

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.

Time frame: day One

DE CT image quality

To evaluate DE CT image quality using a consensus DECT protocol

Time frame: day One

Secondary Outcomes

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

Time frame: day One

Data from ClinicalTrials.gov

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