NCT00846079

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3 coronary-artery-disease

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_3 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

February 18, 2009

Status Verified

February 1, 2009

Enrollment Period

7 months

First QC Date

February 17, 2009

Last Update Submit

February 17, 2009

Conditions

Keywords

coronary artery diseasestress testing

Outcome Measures

Primary Outcomes (1)

  • Diagnostic Accuracy (Sensitivity/Specificity/Positive Predictive Value/Negative Predictive Value)

    6 months

Secondary Outcomes (1)

  • Radiation dosimetry

    6 months

Interventions

Regadenason, typical dosing

Also known as: Lexiscan

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults \>18 years of age
  • Adults undergoing myocardial perfusion SPECT imaging
  • Adults with suspected coronary artery disease

You may not qualify if:

  • Age \<18
  • Known or suspected renal insufficiency (Creatinine \<1.7 mg/dl)
  • Allergy to contrast
  • Inability or contraindication to lexiscan or beta blocker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tennessee Heart and Vascular Institute

Hendersonville, Tennessee, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 17, 2009

First Posted

February 18, 2009

Study Start

February 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

February 18, 2009

Record last verified: 2009-02

Locations