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

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:

Drug Information available for: Insulin Insulin human

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

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Eligibility


Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
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

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, see Learn About Clinical Studies.

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

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
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, Globin Zinc Insulin Hypoglycemic Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 28, 2016