Status:
COMPLETED
Clinical and Angiographic Outcomes With Hyperglycemic Control Post PCI
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
Heart and Stroke Foundation of Canada
Conditions:
Diabetes Mellitus
Coronary Restenosis
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
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 res...
Detailed Description
Studies consistently show that diabetes (DM) is an independent predictor of angiographic restenosis as well as clinical outcomes after PCI. A common criticism of the early PCI trials is that stents we...
Eligibility Criteria
Inclusion
- Patients booked for catheter-based revascularization with balloon angioplasty and coronary stent placement
- Type II diabetes mellitus
- On 0-2 oral glucose lowering agents and able to double the dose of (or add) at least one glucose lowering agent. If HbA1c is 0.100-0.104, then must be on only 0-1 oral antidiabetic agents (the dose of one agent must be ≤ ½ max dose) and able to take metformin (i.e. no previous intolerance; and serum creatinine \< 130 mol/L)
Exclusion
- Planned staged procedure for multivessel PCI taking place over \> 30 days
- Estimated LVEF \< 35%, if known
- NYHA class 3 or 4 symptoms of CHF
- HbA1c \< 0.061 or \> 0..104.
- Current or anticipated need for insulin or TZD within the next 6 months
- On \> 50% of the maximum doses of an insulin secretagogue and unable to take metformin because of previous intolerance, or because of a serum creatinine 130 mol/L
- Refusal to take insulin
- Refusal to do home glucose monitoring
- History of hypoglycemia requiring 3rd party assistance in the last 2 years
- Noncardiac illness expected to limit survival.
- Renal insufficiency (participants not on metformin creatinine \> 180 mol/L; participants on metformin creatinine \> 130 mol/L)
- Known hepatic disease (ALT \> 2 X ULN, if known)
- Suspected or known pregnancy
- Refusal/unable to return for follow-up.
- Enrolled in a competing randomized trial or clinical study.
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00412126
Start Date
July 1 2002
End Date
September 1 2005
Last Update
December 15 2006
Active Locations (1)
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1
McMaster University/Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2