Myocardial Perfusion Assessment With Multidetector Computed Tomography

February 17, 2009 updated by: Tennessee Heart and Vascular Institute, P.C.
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Hendersonville, Tennessee, United States
        • Tennessee Heart and Vascular Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnostic Accuracy (Sensitivity/Specificity/Positive Predictive Value/Negative Predictive Value)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Radiation dosimetry
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tennessee Heart and Vascular Institute, P.C.

Collaborators

General Electric

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Anticipated)

September 1, 2009

Study Completion (Anticipated)

September 1, 2009

Study Registration Dates

First Submitted

February 17, 2009

First Submitted That Met QC Criteria

February 17, 2009

First Posted (Estimate)

February 18, 2009

Study Record Updates

Last Update Posted (Estimate)

February 18, 2009

Last Update Submitted That Met QC Criteria

February 17, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THVI-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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