Clinical and Angiographic Outcomes With Hyperglycemic Control Post PCI

Study Description

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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 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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus; Coronary Restenosis	Drug: Insulin	Not Applicable

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Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	240 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Does Reduction of Hyperglycemia With Insulin Impact Restenosis and Improve Clinical Outcomes Following PCI?
Study Start Date :	July 2002
Study Completion Date :	September 2005

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. Volume of intimal hyperplasia in the stented segment by IVUS at 6 months following PCI

Secondary Outcome Measures :

1. 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)

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

Canada, Ontario
McMaster University/Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2

Sponsors and Collaborators

Hamilton Health Sciences Corporation

Heart and Stroke Foundation of Canada

Investigators

Principal Investigator:	Madhu K Natarajan, MD, FRCPC	Hamilton Health Sciences Corporation

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Natarajan MK, Strauss BH, Rokoss M, Buller CE, Mancini GB, Xie C, Sheth TN, Goodhart D, Cohen EA, Seidelin P, Harper W, Gerstein HC. Randomized trial of insulin versus usual care in reducing restenosis after coronary intervention in patients with diabetes. the STent Restenosis And Metabolism (STREAM) study. Cardiovasc Revasc Med. 2012 Mar-Apr;13(2):95-100. doi: 10.1016/j.carrev.2011.12.001. Epub 2012 Jan 30.

ClinicalTrials.gov Identifier:	NCT00412126 History of Changes
Other Study ID Numbers:	01-223
First Posted:	December 15, 2006
Last Update Posted:	December 15, 2006
Last Verified:	December 2006

Keywords provided by McMaster University:

Diabetes Mellitus; Coronary Restenosis; Insulin; Angioplasty

Additional relevant MeSH terms:

Diabetes Mellitus; Coronary Restenosis; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Coronary Stenosis; Coronary Disease; Myocardial Ischemia	Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Insulin, Globin Zinc; Insulin; Hypoglycemic Agents; Physiological Effects of Drugs