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

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ClinicalTrials.gov Identifier: NCT00162357
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : April 15, 2011
Sponsor:
Information provided by:
Lantheus Medical Imaging

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Coronary Restenosis Drug: Technetium Tc99m Sestamibi Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : April 2004
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Evaluate symptom-free heart blockages that develop following initial opening in patients with Type II diabetes mellitus based on Cardiolite imaging

Secondary Outcome Measures :
  1. Determine how often symptom-free heart blockages occur 5-6 months after opening in patients with Type II diabetes mellitus
  2. 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.
  3. Compare patient hospital and out-patient cost for cardiac care for each group of patients (MPI versus standard care).

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162357


Locations
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United States, Connecticut
Local Institution
Hartford, Connecticut, United States
Local Institution
Waterbury, Connecticut, United States
United States, Michigan
Local Institution
Grand Rapids, Michigan, United States
United States, New York
Local Institution
Roslyn, New York, United States
United States, Vermont
Local Institution
Burlington, Vermont, United States
United States, Virginia
Local Institution
Roanoke, Virginia, United States
United States, Wisconsin
Local Institution
Wausau, Wisconsin, United States
Puerto Rico
Local Institution
San Juan, Puerto Rico
Sponsors and Collaborators
Lantheus Medical Imaging
Investigators
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Study Director: Qi Zhu, MD Lantheus Medical Imaging
More Information
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Responsible Party: Qi Zhu, MD Sr. Medical Director, Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT00162357     History of Changes
Other Study ID Numbers: CARDIOLITE-406
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: April 15, 2011
Last Verified: April 2011
Additional relevant MeSH terms:
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Coronary Restenosis
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Coronary Stenosis
Coronary Disease
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Technetium Tc 99m Sestamibi
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action