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

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-13
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-14
• Last Update Posted: 2011-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evaluate symptom-free heart blockages that develop following initial opening in patients with Type II diabetes mellitus based on Cardiolite imaging

Secondary Outcome Measures

Name	Time	Method
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