Post-PCI:Cardiac Imaging in Patients With Diabetes to Detect Coronary Artery Blockages Previously Opened by Angioplasty
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
1 other identifier
interventional
106
2 countries
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 diabetes-mellitus-type-2
Started Apr 2004
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 13, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedApril 15, 2011
April 1, 2011
1.7 years
September 9, 2005
April 14, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate symptom-free heart blockages that develop following initial opening in patients with Type II diabetes mellitus based on Cardiolite imaging
Secondary Outcomes (3)
Determine how often symptom-free heart blockages occur 5-6 months after opening in patients with Type II diabetes mellitus
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.
Compare patient hospital and out-patient cost for cardiac care for each group of patients (MPI versus standard care).
Interventions
Eligibility Criteria
You may qualify if:
- Type II Diabetes on medication \& angioplasty within the past 6 months.
You may not qualify if:
- Myocardial infarction or repeat angioplasty with the past 5 months.
- Unable to perform exercise or pharmacologic stress test.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Local Institution
Hartford, Connecticut, United States
Local Institution
Waterbury, Connecticut, United States
Local Institution
Grand Rapids, Michigan, United States
Local Institution
Roslyn, New York, United States
Local Institution
Burlington, Vermont, United States
Local Institution
Roanoke, Virginia, United States
Local Institution
Wausau, Wisconsin, United States
Local Institution
San Juan, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Qi Zhu, MD
Lantheus Medical Imaging
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 13, 2005
Study Start
April 1, 2004
Primary Completion
December 1, 2005
Study Completion
December 1, 2005
Last Updated
April 15, 2011
Record last verified: 2011-04