Post-PCI:Cardiac Imaging in Patients With Diabetes to Detect Coronary Artery Blockages Previously Opened by Angioplasty
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00162357 |
Recruitment Status :
Completed
First Posted : September 13, 2005
Last Update Posted : April 15, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 2 Coronary Restenosis | Drug: Technetium Tc99m Sestamibi | Phase 4 |
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 |

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

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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
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 |
Study Director: | Qi Zhu, MD | Lantheus Medical Imaging |
Responsible Party: | Qi Zhu, MD Sr. Medical Director, Lantheus Medical Imaging |
ClinicalTrials.gov Identifier: | NCT00162357 |
Other Study ID Numbers: |
CARDIOLITE-406 |
First Posted: | September 13, 2005 Key Record Dates |
Last Update Posted: | April 15, 2011 |
Last Verified: | April 2011 |
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 |