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Myocardial Perfusion Assessment With Multidetector Computed Tomography

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Tennessee Heart and Vascular Institute, P.C..
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
General Electric
Information provided by:
Tennessee Heart and Vascular Institute, P.C.
ClinicalTrials.gov Identifier:
NCT00846079
First received: February 17, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
 Device: Regadenoson (Lexiscan) [muti-detector computed tomography]
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Myocardial Perfusion Assessment With Multidetector Computed Tomography

Resource links provided by NLM:

Drug Information available for: Regadenoson
U.S. FDA Resources

Further study details as provided by Tennessee Heart and Vascular Institute, P.C.:

Primary Outcome Measures:
  • Diagnostic Accuracy (Sensitivity/Specificity/Positive Predictive Value/Negative Predictive Value) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Radiation dosimetry [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2009
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Regadenoson (Lexiscan) [muti-detector computed tomography]
    Regadenason, typical dosing
    Other Name: Lexiscan
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00846079

Locations
United States, Tennessee
Tennessee Heart and Vascular Institute
Hendersonville, Tennessee, United States
Sponsors and Collaborators
Tennessee Heart and Vascular Institute, P.C.
General Electric
  More Information

No publications provided

Responsible Party: Tracy Callister,MD, Tennessee Heart and Vascular Institute, P.C.
ClinicalTrials.gov Identifier: NCT00846079     History of Changes
Other Study ID Numbers: THVI-101
Study First Received: February 17, 2009
Last Updated: February 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Tennessee Heart and Vascular Institute, P.C.:
coronary artery disease
stress testing

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Regadenoson
 Adenosine A2 Receptor Antagonists
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2012