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Viability Imaging in Volumetric Angiography (VIVA 1)

This study has been terminated.
(PI/Project director no longer at facility)
Sponsor:
Information provided by (Responsible Party):
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT01408134
First received: July 28, 2011
Last updated: March 28, 2013
Last verified: March 2013
History of Changes
  Purpose

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

Condition Intervention
Myocardial Scarring
 Other: DE CT

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Viability Imaging in Volumetric Angiography (VIVA 1): A Single Center Trial of the Detection of Delayed Hyperenhancement on CT Angiography

Resource links provided by NLM:

MedlinePlus related topics: Nuclear Scans Scars
U.S. FDA Resources

Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:
  • Inter-reader variability of myocardial viability [ Time Frame: day One ] [ Designated as safety issue: No ]

    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 [ Time Frame: day One ] [ Designated as safety issue: No ]
    To evaluate DE CT image quality using a consensus DECT protocol


Secondary Outcome Measures:
  • Scan and patient factors related to the image quality [ Time Frame: day One ] [ Designated as safety issue: No ]
    The secondary endpoint will be to describe the scan and patient factors related to the image quality on myocardial CT perfusion imaging


Enrollment: 10
Study Start Date: June 2011
Study Completion Date: February 2013
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01408134

Locations
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Medstar Research Institute
  More Information

No publications provided

Responsible Party: Medstar Research Institute
ClinicalTrials.gov Identifier: NCT01408134     History of Changes
Other Study ID Numbers: VIVA 1
Study First Received: July 28, 2011
Last Updated: March 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medstar Research Institute:
Inter-reader variability of myocardial viability imaging

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013