Clinical and Angiographic Outcomes With Hyperglycemic Control Post PCI

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamilton Health Sciences Corporation
• Collaborator: Heart and Stroke Foundation of Canada
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

1. Patients booked for catheter-based revascularization with balloon angioplasty and coronary stent placement

2. Type II diabetes mellitus

3. 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 Criteria:

1. Planned staged procedure for multivessel PCI taking place over > 30 days

2. Estimated LVEF < 35%, if known

3. NYHA class 3 or 4 symptoms of CHF

4. HbA1c < 0.061 or > 0..104.

5. Current or anticipated need for insulin or TZD within the next 6 months

6. 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

7. Refusal to take insulin

8. Refusal to do home glucose monitoring

9. History of hypoglycemia requiring 3rd party assistance in the last 2 years

10. Noncardiac illness expected to limit survival.

11. Renal insufficiency (participants not on metformin  creatinine > 180 mol/L; participants on metformin  creatinine > 130 mol/L)

12. Known hepatic disease (ALT > 2 X ULN, if known)

13. Suspected or known pregnancy

14. Refusal/unable to return for follow-up.

15. Enrolled in a competing randomized trial or clinical study.