Viability Imaging in Volumetric Angiography (VIVA 1) (VIVA 1)

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

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

Study Overview

• Status: Terminated
• Conditions: Myocardial Scarring
• Intervention / Treatment: Other: DE CT

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: July 28, 2011
• First Submitted That Met QC Criteria: August 2, 2011
• First Posted (Estimate): August 3, 2011

Study Record Updates

• Last Update Posted (Estimate): March 29, 2013
• Last Update Submitted That Met QC Criteria: March 28, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Inter-reader variability of myocardial viability imaging
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix
• Other Study ID Numbers: VIVA 1