Not Signed In -
Diabetes |
Blood Sugar; Diabetes Mellitus; Non-Insulin Dependent Diabetes Mellitus; Type II Diabetes |
Clinical Trial: Post-PCI:Cardiac Imaging in Patients with Diabetes to Detect Coronary Artery Blockages Previously Opened by Angioplasty
This study is currently recruiting patients.
Verified by Bristol-Myers Squibb September 2005
|
Purpose
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 | Intervention | Phase |
|---|---|---|
| Diabetes Mellitus, Type 2 Coronary Restenosis | Drug: Technetium Tc99m Sestamibi | Phase IV |
MedlinePlus related topics: Coronary Disease; Diabetes
Study Type: Interventional
Study Design: Diagnostic, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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
Further Study Details:
Primary Outcomes: Evaluate symptom-free heart blockages that develop following initial opening in patients with Type II diabetes mellitus based on Cardiolite imaging
Secondary Outcomes: 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).
Expected Total Enrollment: 400
Secondary Outcomes: 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).
Expected Total Enrollment: 400
Study start: March 2004
Eligibility
Ages Eligible for Study: 21 Years and above, Genders Eligible for Study: Both
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.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00162357
BMS Call Center 1 866 892 1BMS Ext. 201
Connecticut
Local Institution, Waterbury, Connecticut, United States; Recruiting
Local Institution, Hartford, Connecticut, United States; Recruiting
Michigan
Local Institution, Grand Rapids, Michigan, United States; Recruiting
New York
Local Institution, Roslyn, New York, United States; Recruiting
Vermont
Local Institution, Burlington, Vermont, United States; Recruiting
Virginia
Local Institution, Roanoke, Virginia, United States; Recruiting
Wisconsin
Local Institution, Wausau, Wisconsin, United States; Recruiting
Puerto Rico
Local Institution, San Juan, Puerto Rico; Recruiting
Study chairs or principal investigators
Martin Rosenberg, MD, Principal Investigator, Bristol Myers Squibb Medical Imaging
More Information
Study ID Numbers: CARDIOLITE-406
Last Updated: September 12, 2005
Record first received: September 9, 2005
ClinicalTrials.gov Identifier: NCT00162357
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 12, 2005
Record first received: September 9, 2005
ClinicalTrials.gov Identifier: NCT00162357
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13
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