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Myocardial Perfusion Assessment With Multidetector Computed Tomography

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Tennessee Heart and Vascular Institute, P.C..
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00846079
First Posted: February 18, 2009
Last Update Posted: February 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
General Electric
Information provided by:
Tennessee Heart and Vascular Institute, P.C.
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Myocardial Perfusion Assessment With Multidetector Computed Tomography

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • Radiation dosimetry [ Time Frame: 6 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: February 17, 2009
First Posted: February 18, 2009
Last Update Posted: February 18, 2009
Last Verified: February 2009

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 Agonists
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs