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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |

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 |
- Volume of intimal hyperplasia in the stented segment by IVUS at 6 months following PCI
- 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)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 90 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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