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Clinical and Angiographic Outcomes With Hyperglycemic Control Post PCI

This study has been completed.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Canada
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00412126
First received: December 13, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted
  Purpose

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 Intervention
Diabetes Mellitus
Coronary Restenosis
 Drug: Insulin

Study Type: Interventional
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?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Volume of intimal hyperplasia in the stented segment by IVUS at 6 months following PCI

Secondary Outcome Measures:
  • 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)

Estimated Enrollment: 240
Study Start Date: July 2002
Estimated Study Completion Date: September 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by McMaster University

Additional 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
Study First Received: December 13, 2006
Last Updated: December 13, 2006
Health Authority: Canada: Health Canada

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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013