Status:
COMPLETED
A Study Comparing Standard Care for Diabetes to Case-Managed Care for Diabetes in Patients With Coronary Artery Disease
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Collaborating Sponsors:
Sanofi
Pfizer
Conditions:
Diabetes Mellitus, Type 2
Coronary Disease
Eligibility:
All Genders
Phase:
NA
Brief Summary
The purpose of this study is to compare two ways to treat patients with Type 2 Diabetes, Standard Care or Case-Managed Care. In-Patient Standard Care is guided by the assigned cardiologist and Out-Pa...
Detailed Description
Patients with diabetes have a higher incidence of coronary artery disease and a worsened cardiac prognosis. Death from cardiovascular disease accounts for about 70% of all diabetes-related deaths (Boo...
Eligibility Criteria
Inclusion
- Diabetes Mellitus, type 2, as defined by at least one of the following:
- Previous diagnosis of diabetes
- two glucose levels consistent with diabetes (fasting glucose \>7.0 mmol/L or random glucose \>11.0 mmol/L )
- HbA1C \> 6.5% using DCCT standardized methods And
- Coronary Disease, as defined by at least one of the following:
- Admitting diagnosis of acute coronary syndrome defined by 2/3 of typical history, enzyme changes, dynamic ECG changes
- Prior history of acute coronary syndrome defined as above
- Previously documented myocardial infarction
- Previous coronary revascularization procedure
- Coronary artery disease defined by coronary angiography
- Exercise or persantine nuclear perfusion imaging positive for ischemia
Exclusion
- Refusal to enter the study
- Inability to understand consent forms and provide informed consent
- Anticipated length of non-ICU hospital stay less than 48 hours
- Diabetes Mellitus, type 1
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2007
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT00248352
Start Date
February 1 2005
End Date
October 1 2007
Last Update
October 26 2007
Active Locations (1)
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1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7