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Clinical and Angiographic Outcomes With Hyperglycemic Control Post PCI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00412126
Recruitment Status : Completed
First Posted : December 15, 2006
Last Update Posted : December 15, 2006
Sponsor:
Collaborator:
Heart and Stroke Foundation of Canada
Information provided by:
McMaster University

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
Diabetes Mellitus Coronary Restenosis Drug: Insulin

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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)


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00412126


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00412126     History of Changes
Other Study ID Numbers: 01-223
First Posted: December 15, 2006    Key Record Dates
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