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CompletedNCT00162344Updated Apr 15, 2011

A Study of Stress Heart Imaging in Patients With Diabetes at Risk for Coronary Disease.

A Phase 4 interventional study of Technetium Tc99m Sestamibi in Diabetes, sponsored by Lantheus Medical Imaging. Completed at 12 sites in 2 countries. Open to participants aged 18 Years to 76 Years. Per ClinicalTrials.gov, last updated 2011-04-15.

Sponsored by Lantheus Medical Imaging · Phase 4, Interventional, and Diagnostic

Phase
Phase 4
Study type
Interventional
Enrollment
205
Allocation
Non-randomized
Ages
18 Years to 76 Years
Sex
All
01

Study summary

The study is designed to see if stress heart imaging can be used as a screening exam in patients with diabetes and risk factors of developing of coronary artery disease and experiencing future cardiac events.

02

Conditions studied

  • Diabetes

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03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 205 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Lantheus Medical Imaging is the lead sponsor of 30 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 76 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • History of diabetes for at least 5 years, with a least 2 risk factors (i.e. hypertension, elevated cholesterol levels, history of or current smoker, obese, family history of heart disease) \& atypical chest pain.

Exclusion criteria

Exclusion Criteria:

  • Typical chest pain being treated with medication, unable to exercise, previous confirmed heart disease
05

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
205 participants (actual)

Interventions

  • DrugTechnetium Tc99m Sestamibi
06

What researchers measure

Primary outcomes

  1. Examine the prevalence of ischemic heart disease in population of patients with diabetes mellitus and atypical chest pain.

Secondary outcomes

  1. Determine the accuracy of myocardial perfusion imaging (MPI) and exercise tolerance testing (ETT) for the detection of coronary artery disease (CAD) in a subset of patients undergoing clinically indicated coronary angiography.

  2. Determine the relative value of ETT, Duke Treadmill Score (DTS), MPI, ejection fraction (EF), clinical risk factors, and C-Reactive Protein (CRP) values for identifying patients at risk for cardiac events.

07

Study locations

12 sites
  • Local Institution
    Mission Viejo, California, United States
  • Local Institution
    Rancho Santa Fe, California, United States
  • Local Institution
    San Diego, California, United States
  • Local Institution
    Chicago, Illinois, United States
  • Local Institution
    Indianapolis, Indiana, United States
  • Local Institution
    Detroit, Michigan, United States
  • Local Institution
    Minneapolis, Minnesota, United States
  • Local Institution
    Albany, New York, United States
  • Local Institution
    Roslyn, New York, United States
  • Local Institution
    Columbus, Ohio, United States
  • Local Institution
    Houston, Texas, United States
  • Local Institution
    Montreal, Quebec, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00162344
Lead sponsor
Lantheus Medical Imaging
First posted
Sep 13, 2005
Start date
Dec 2003
Primary completion
Dec 2005
Completion
Dec 2005
Last update
Apr 15, 2011

Study contacts

Martin Rosenberg, MD
principal investigator · Bristol-Myers Squibb
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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