NCT01047150

Brief Summary

Research Questions:

  1. 1.Is there a significant difference between the causal repeat rate of myocardial perfusion studies for Tc99m tetrofosmin and Tc99m sestamibi?
  2. 2.Is there a significant difference in the causal repeat rate of myocardial perfusion studies for Tc99m tetrofosmin and Tc99m sestamibi if an independent technologist reviewer blinded to the radiopharmaceutical makes the decision to repeat the study?
  3. 3.Is there a significant difference in the quantitative diagnostic measures reported between the original and the acceptable repeated studies?

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
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Shorter than P25 for all trials

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

January 1, 2010

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2010

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

January 12, 2010

Status Verified

December 1, 2009

Enrollment Period

1 month

First QC Date

January 11, 2010

Last Update Submit

January 11, 2010

Conditions

Myocardial Ischemia

Keywords

Myocardial Perfusion ImagingRepeat studiesTetrofosminSestamibi

Outcome Measures

Primary Outcomes (1)

  • Number of studies repeated.

    four weeks

Secondary Outcomes (1)

  • Number of studies that should have been repeated

    two weeks after data collection

Study Arms (4)

Tetrofosmin Rest patients

Patients that had a Rest myocardial perfusion study using Tc99m tetrofosmin

Sestamibi stress patients

Patients that had a stress myocardial perfusion imaging study using Tc99m Sestamibi

Tetrofosmin stress patients

Patients that had a stress myocardial perfusion imaging study using Tc99m Tetrofosmin

Sestamibi rest patients

Patients that had a rest myocardial perfusion imaging study using Tc99m Sestamibi

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred for MPI

You may qualify if:

  • Patients receiving sestamibi MPI study or tetrofosmin MPI study

You may not qualify if:

  • Thallium or dual isotope MPI study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiac Imaging of Augusta

Augusta, Georgia, 30901, United States

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Danny A Basso, CNMT

    Cardiac Imaging of Augusta

    STUDY DIRECTOR

Central Study Contacts

Danny A Basso, CNMT

CONTACT

7067243926dbasso@knology.net

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 11, 2010

First Posted

January 12, 2010

Study Start

January 1, 2010

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

January 12, 2010

Record last verified: 2009-12

Locations

US(1)