Myocardial Perfusion Assessment With Multidetector Computed Tomography

This study is ongoing, but not recruiting participants.

First Received: February 17, 2009 No Changes Posted

Sponsors and Collaborators:	Tennessee Heart and Vascular Institute, P.C. General Electric
Information provided by:	Tennessee Heart and Vascular Institute, P.C.
ClinicalTrials.gov Identifier:	NCT00846079

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 III

MedlinePlus related topics: CT Scans Coronary Artery Disease

Drug Information available for: CVT 3146

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Myocardial Perfusion Assessment With Multidetector Computed Tomography

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:

Regadenason, typical dosing

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

Keywords provided by Tennessee Heart and Vascular Institute, P.C.:

coronary artery disease
stress testing

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Stress
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 07, 2009