NCT00412126

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Jul 2002

Typical duration for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2006

Completed
Last Updated

December 15, 2006

Status Verified

December 1, 2006

First QC Date

December 13, 2006

Last Update Submit

December 13, 2006

Conditions

Diabetes MellitusCoronary Restenosis

Keywords

Diabetes MellitusCoronary RestenosisInsulinAngioplasty

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (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)

Interventions

InsulinDRUG

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University/Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (1)

  • 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.

    PMID: 22296781DERIVED

MeSH Terms

Conditions

Diabetes MellitusCoronary RestenosisInsulin Resistance

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCoronary StenosisCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Madhu K Natarajan, MD, FRCPC

    Hamilton Health Sciences Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 13, 2006

First Posted

December 15, 2006

Study Start

July 1, 2002

Study Completion

September 1, 2005

Last Updated

December 15, 2006

Record last verified: 2006-12

Locations

CA(1)