- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00286572
Long-term Mortality in Diabetics Undergoing Major Surgery
Comparison in Survival in Patients With Insulin-dependent and Non-insulin-dependent Diabetes Mellitus With Known or Suspected Coronary Artery Disease Undergoing Major Non-cardiac Surgery
Study Overview
Status
Detailed Description
Diabetes mellitus is an important risk factor for arteriosclerosis in general and for coronary artery disease. Patients with CAD have a worse prognosis if they have diabetes mellitus. But it is not known whether the treatment of Dm has an influence on mortality or morbidity.
In face of the high number of patients with Dm and the therapeutic consequences this prospective study wants to compare short-time and long-time morbidity in Patients with Dm undergoing major non-vascular surgery. Inclusion criteria are medically treated Dm (insulin or oral antidiabetics) and major non cardiac surgery.
The "normal" perioperative treatment of the study is not changed by the study itself.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
CH
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Basel, CH, Switzerland, 4000
- University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- diabetes mellitus with insulin or oral antidiabetics
- proven coronary artery disease or very high risk for it
- major non-vascular surgery
Exclusion Criteria:
- emergency
- no consent
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Death and/or major adverse cardiac events
Time Frame: 12 months after surgery
|
12 months after surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Miodrag Filipovic, PD Dr., University Hospital, Basel, Switzerland
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 129/03
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