Study Stopped
PI/Project director no longer at facility
Viability Imaging in Volumetric Angiography (VIVA 1)
VIVA 1
1 other identifier
interventional
10
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 28, 2011
CompletedFirst Posted
Study publicly available on registry
August 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedMarch 29, 2013
March 1, 2013
8 months
July 28, 2011
March 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Scan and patient factors related to the image quality
day One
Interventions
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2011
First Posted
August 3, 2011
Study Start
June 1, 2011
Primary Completion
February 1, 2012
Study Completion
February 1, 2013
Last Updated
March 29, 2013
Record last verified: 2013-03