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

Primary Purpose

Myocardial Scarring

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DE CT
Sponsored by
Medstar Health Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocardial Scarring focused on measuring Inter-reader variability of myocardial viability imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington Hospital Center

Outcomes

Primary Outcome Measures

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.
DE CT image quality
To evaluate DE CT image quality using a consensus DECT protocol

Secondary Outcome Measures

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

Full Information

First Posted
July 28, 2011
Last Updated
March 28, 2013
Sponsor
Medstar Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01408134
Brief Title
Viability Imaging in Volumetric Angiography (VIVA 1)
Acronym
VIVA 1
Official Title
Viability Imaging in Volumetric Angiography (VIVA 1): A Single Center Trial of the Detection of Delayed Hyperenhancement on CT Angiography
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Why Stopped
PI/Project director no longer at facility
Study Start Date
June 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medstar Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Scarring
Keywords
Inter-reader variability of myocardial viability imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
DE CT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Inter-reader variability of myocardial viability
Description
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
Title
DE CT image quality
Description
To evaluate DE CT image quality using a consensus DECT protocol
Time Frame
day One
Secondary Outcome Measure Information:
Title
Scan and patient factors related to the image quality
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States

12. IPD Sharing Statement

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Viability Imaging in Volumetric Angiography (VIVA 1)

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