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

Phase 4
Completed
Conditions
Diabetes Mellitus, Type 2
Coronary Restenosis
Registration Number
NCT00162357
Lead Sponsor
Lantheus Medical Imaging
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
106
Inclusion Criteria
  • Type II Diabetes on medication & angioplasty within the past 6 months.
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Exclusion Criteria
  • Myocardial infarction or repeat angioplasty with the past 5 months.
  • Unable to perform exercise or pharmacologic stress test.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Evaluate symptom-free heart blockages that develop following initial opening in patients with Type II diabetes mellitus based on Cardiolite imaging
Secondary Outcome Measures
NameTimeMethod
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).

Trial Locations

Locations (1)

Local Institution

🇵🇷

San Juan, Puerto Rico

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