Viability Imaging in Volumetric Angiography (VIVA 1)

Not Applicable

Terminated

• Conditions: Myocardial Scarring

• Registration Number: NCT01408134
• Lead Sponsor: Medstar Health Research Institute

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-28
• Study First Submitted QC: 2011-08-02
• Study First Posted: 2011-08-03
• Primary Completion: 2012-02
• Study Completion: 2013-02
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-28
• Last Update Posted: 2013-03-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Inter-reader variability of myocardial viability	day One	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	day One	To evaluate DE CT image quality using a consensus DECT protocol

Secondary Outcome Measures

Name	Time	Method
Scan and patient factors related to the image quality	day One	The secondary endpoint will be to describe the scan and patient factors related to the image quality on myocardial CT perfusion imaging

Trial Locations

Locations (1)

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States