Post-PCI:Cardiac Imaging in Patients With Diabetes to Detect Coronary Artery Blockages Previously Opened by Angioplasty
This study has been completed.
Sponsor:
Lantheus Medical Imaging
Information provided by:
Lantheus Medical Imaging
ClinicalTrials.gov Identifier:
NCT00162357
First received: September 9, 2005
Last updated: April 14, 2011
Last verified: April 2011
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Lantheus Medical Imaging:
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).
| Enrollment: | 106 |
| Study Start Date: | April 2004 |
| Study Completion Date: | December 2005 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162357
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162357
Locations
| 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
| Study Director: | Qi Zhu, MD | Lantheus Medical Imaging |
More Information
| Responsible Party: | Qi Zhu, MD Sr. Medical Director, Lantheus Medical Imaging |
| ClinicalTrials.gov Identifier: | NCT00162357 History of Changes |
| Other Study ID Numbers: | CARDIOLITE-406 |
| Study First Received: | September 9, 2005 |
| Last Updated: | April 14, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Coronary Restenosis 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 |
ClinicalTrials.gov processed this record on September 23, 2016