Back to resultsMyocardial Perfusion Assessment With Multidetector Computed Tomography
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Regadenoson (Lexiscan) [muti-detector computed tomography]
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring coronary artery disease, stress testing
Eligibility Criteria
Inclusion Criteria:
- Adults >18 years of age
- Adults undergoing myocardial perfusion SPECT imaging
- Adults with suspected coronary artery disease
Exclusion Criteria:
- Age <18
- Known or suspected renal insufficiency (Creatinine <1.7 mg/dl)
- Allergy to contrast
- Inability or contraindication to lexiscan or beta blocker
Sites / Locations
- Tennessee Heart and Vascular Institute
Outcomes
Primary Outcome Measures
Diagnostic Accuracy (Sensitivity/Specificity/Positive Predictive Value/Negative Predictive Value)
Secondary Outcome Measures
Radiation dosimetry
Full Information
NCT ID
NCT00846079
First Posted
February 17, 2009
Last Updated
February 17, 2009
Sponsor
Tennessee Heart and Vascular Institute, P.C.
Collaborators
General Electric
1. Study Identification
Unique Protocol Identification Number
NCT00846079
Brief Title
Myocardial Perfusion Assessment With Multidetector Computed Tomography
Official Title
Myocardial Perfusion Assessment With Multidetector Computed Tomography
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
September 2009 (Anticipated)
Study Completion Date
September 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Tennessee Heart and Vascular Institute, P.C.
Collaborators
General Electric
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Demonstrate the ability of muti-detector computed tomography to adequately perform stress testing will result in a veritable "one-stop shop" of non-invasive cardiac imaging that is, the ability to directly visualize heart arteries with high accuracy and to simultaniously determine the hemodynamic significance of any blockages visualized.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary artery disease, stress testing
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Regadenoson (Lexiscan) [muti-detector computed tomography]
Other Intervention Name(s)
Lexiscan
Intervention Description
Regadenason, typical dosing
Primary Outcome Measure Information:
Title
Diagnostic Accuracy (Sensitivity/Specificity/Positive Predictive Value/Negative Predictive Value)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Radiation dosimetry
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults >18 years of age
Adults undergoing myocardial perfusion SPECT imaging
Adults with suspected coronary artery disease
Exclusion Criteria:
Age <18
Known or suspected renal insufficiency (Creatinine <1.7 mg/dl)
Allergy to contrast
Inability or contraindication to lexiscan or beta blocker
Facility Information:
Facility Name
Tennessee Heart and Vascular Institute
City
Hendersonville
State/Province
Tennessee
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Myocardial Perfusion Assessment With Multidetector Computed Tomography
We'll reach out to this number within 24 hrs