search
Back to results

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

Primary Purpose

Diabetes Mellitus, Type 2, Coronary Restenosis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Technetium Tc99m Sestamibi
Sponsored by
Lantheus Medical Imaging
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetes Mellitus, Type 2

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).

Full Information

First Posted
September 9, 2005
Last Updated
April 14, 2011
Sponsor
Lantheus Medical Imaging
search

1. Study Identification

Unique Protocol Identification Number
NCT00162357
Brief Title
Post-PCI:Cardiac Imaging in Patients With Diabetes to Detect Coronary Artery Blockages Previously Opened by Angioplasty
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Lantheus Medical Imaging

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Coronary Restenosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Technetium Tc99m Sestamibi
Primary Outcome Measure Information:
Title
Evaluate symptom-free heart blockages that develop following initial opening in patients with Type II diabetes mellitus based on Cardiolite imaging
Secondary Outcome Measure Information:
Title
Determine how often symptom-free heart blockages occur 5-6 months after opening in patients with Type II diabetes mellitus
Title
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.
Title
Compare patient hospital and out-patient cost for cardiac care for each group of patients (MPI versus standard care).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qi Zhu, MD
Organizational Affiliation
Lantheus Medical Imaging
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Hartford
State/Province
Connecticut
Country
United States
Facility Name
Local Institution
City
Waterbury
State/Province
Connecticut
Country
United States
Facility Name
Local Institution
City
Grand Rapids
State/Province
Michigan
Country
United States
Facility Name
Local Institution
City
Roslyn
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Burlington
State/Province
Vermont
Country
United States
Facility Name
Local Institution
City
Roanoke
State/Province
Virginia
Country
United States
Facility Name
Local Institution
City
Wausau
State/Province
Wisconsin
Country
United States
Facility Name
Local Institution
City
San Juan
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs