Myocardial Perfusion Assessment With Multidetector Computed Tomography

Coronary Artery Disease Clinical Trial

Official title:

Myocardial Perfusion Assessment With Multidetector Computed Tomography

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00846079
• Other study ID #: THVI-101
• Status: Active, not recruiting
• Phase: Phase 3
• First received: February 17, 2009
• Last updated: February 17, 2009
• Start date: February 2009
• Est. completion date: September 2009

Study information

• Verified date: February 2009
• Source: Tennessee Heart and Vascular Institute, P.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Regadenoson (Lexiscan) [muti-detector computed tomography]
Regadenason, typical dosing

Locations

Country	Name	City	State
United States	Tennessee Heart and Vascular Institute	Hendersonville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Tennessee Heart and Vascular Institute, P.C.	General Electric

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Accuracy (Sensitivity/Specificity/Positive Predictive Value/Negative Predictive Value)		6 months	No
Secondary	Radiation dosimetry		6 months	No