This trial is active, not recruiting.

Condition coronary artery disease
Treatment regadenoson (lexiscan) [muti-detector computed tomography]
Phase phase 3
Sponsor Tennessee Heart and Vascular Institute, P.C.
Collaborator General Electric
Start date February 2009
End date September 2009
Trial size 100 participants
Trial identifier NCT00846079, THVI-101


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic

Primary Outcomes

Diagnostic Accuracy (Sensitivity/Specificity/Positive Predictive Value/Negative Predictive Value)
time frame: 6 months

Secondary Outcomes

Radiation dosimetry
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Myocardial Perfusion Assessment With Multidetector Computed Tomography
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by Tennessee Heart and Vascular Institute, P.C..