Clinical and Angiographic Outcomes With Hyperglycemic Control Post PCI - Full Text View

Sponsors and Collaborators:	Hamilton Health Sciences Heart and Stroke Foundation of Ontario
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00412126

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

MedlinePlus related topics: Angioplasty Diabetes

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Does Reduction of Hyperglycemia With Insulin Impact Restenosis and Improve Clinical Outcomes Following PCI?

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:

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 Criteria:

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.

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

Heart and Stroke Foundation of Ontario

Investigators

Principal Investigator:

Madhu K Natarajan, MD, FRCPC

Hamilton Health Sciences

More Information

Study ID Numbers:	01-223
Study First Received:	December 13, 2006
Last Updated:	December 13, 2006
ClinicalTrials.gov Identifier:	NCT00412126
Health Authority:	Canada: Health Canada

Keywords provided by McMaster University:

Diabetes Mellitus
Coronary Restenosis
Insulin
Angioplasty

Study placed in the following topic categories:

Metabolic Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Constriction, Pathologic
Ischemia
Coronary Restenosis

Coronary Stenosis
Insulin
Coronary Disease
Hyperglycemia
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Coronary Artery Disease

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009