Post-PCI:Cardiac Imaging in Patients With Diabetes to Detect Coronary Artery Blockages Previously Opened by Angioplasty

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Cardiolite-406; A Phase IV Open-Label, Randomized, Multi-Center Trial To Evaluate The Ability of Cardiolite Stress MPI to Detect Asymptomatic Restenosis in Diabetic Patients Who Have Undergone Percutaneous Coronary Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00162357
• Other study ID #: CARDIOLITE-406
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: April 14, 2011
• Start date: April 2004
• Est. completion date: December 2005

Study information

• Verified date: April 2011
• Source: Lantheus Medical Imaging
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical research study is determine if patients with diabetes that have undergone previous opening of a heart blockage may have a blockage that is not causing any symptoms that may be detected by imaging with Cardiolite.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Type II Diabetes on medication & angioplasty within the past 6 months.

Exclusion Criteria:

• Myocardial infarction or repeat angioplasty with the past 5 months.

• Unable to perform exercise or pharmacologic stress test.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Restenosis
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Technetium Tc99m Sestamibi

Locations

Country	Name	City	State
Puerto Rico	Local Institution	San Juan
United States	Local Institution	Burlington	Vermont
United States	Local Institution	Grand Rapids	Michigan
United States	Local Institution	Hartford	Connecticut
United States	Local Institution	Roanoke	Virginia
United States	Local Institution	Roslyn	New York
United States	Local Institution	Waterbury	Connecticut
United States	Local Institution	Wausau	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Lantheus Medical Imaging

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate symptom-free heart blockages that develop following initial opening in patients with Type II diabetes mellitus based on Cardiolite imaging
Secondary	Determine how often symptom-free heart blockages occur 5-6 months after opening in patients with Type II diabetes mellitus
Secondary	Examine the relative value of ejection fraction, summed stress, rest, and difference MPI scores for identifying patients with cardiac events during 18 month follow-up.
Secondary	Compare patient hospital and out-patient cost for cardiac care for each group of patients (MPI versus standard care).