Clinical and Angiographic Outcomes With Hyperglycemic Control Post PCI
Coronary artery disease is a process that results in “hardening of the arteries”. When the arteries that supply blood and oxygen to your heart muscle become clogged or narrowed, a heart attack may result, or you may feel chest discomfort (angina) – sometimes even while resting. One approach to treating this condition is a balloon procedure known as coronary angioplasty.
The major limitation of coronary angioplasty is renarrowing of the artery (restenosis) in the first six months following the procedure requiring either repeat angioplasty or referral for bypass surgery. Patients with diabetes have always been identified as having higher rates of restenosis and poor outcomes following angioplasty, despite some important scientific advances. We think that the level of blood sugar control at the time of angioplasty and in the following months may be related to the extent of restenosis.
We expect that a reduction in blood sugar with insulin may, in turn, reduce the restenosis process and improve your long-term outcome.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Does Reduction of Hyperglycemia With Insulin Impact Restenosis and Improve Clinical Outcomes Following PCI?|
- Volume of intimal hyperplasia in the stented segment by IVUS at 6 months following PCI
- Late loss in minimal luminal diameter of stented site in coronary vessel evaluated by QCA at 6 months post-PCIb) Rate of clinical events at one year (hospital admission for unstable angina, CHF, MI, stroke, revascularization, and death)
|Study Start Date:||July 2002|
|Estimated Study Completion Date:||September 2005|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00412126
|McMaster University/Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8L 2X2|
|Principal Investigator:||Madhu K Natarajan, MD, FRCPC||Hamilton Health Sciences Corporation|