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| Sponsored by: |
University Hospital, Basel, Switzerland |
|---|---|
| Information provided by: | University Hospital, Basel, Switzerland |
| ClinicalTrials.gov Identifier: | NCT00286572 |
Purpose
Patients with CAD and diabetes mellitus have a better prognosis than patients with CAD and no diabetes mellitus. In acute coronary syndrome patients with an insulin therapy had a better survival than patients with oral antidiabetics. But there is not known wether perioperative therapy with insulin or oral antidiabetics is associated with higher risk for higher perioperative cardiac morbidity and mortality and worse long-term survival.
| Condition |
|---|
|
Diabetes Mellitus Coronary Heart Disease Major Non-Cardiac Surgery |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | 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 |
| Estimated Enrollment: | 400 |
| Study Start Date: | January 2004 |
| Estimated Study Completion Date: | December 2009 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients with treated diabetes mellitus undergoing surgery with major risk or patients with treated diabetes mellitus and known coronary artery disease undergoing surgery with major or intermediate risk
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Miodrag Filipovic, PD Dr. | 0041-61-2652525 | mfilipovic@uhbs.ch |
| Contact: Daniel Bolliger, Dr. | 0041-61-2652525 | dabolliger@uhbs.ch |
| Switzerland, CH | |
| University Hospital | Active, not recruiting |
| Basel, CH, Switzerland, 4000 | |
| University Hospital | Recruiting |
| Basel, CH, Switzerland, 4000 | |
| Contact: Miodrag Filipovic, PD Dr. 0041-61-2652525 mfilipovic@uhbs.ch | |
| Contact: Daniel Bolliger, Dr. 0041-61-2652525 dabolliger@uhbs.ch | |
| Principal Investigator: | Miodrag Filipovic, PD Dr. | University Hospital, Basel, Switzerland |
More Information
| Responsible Party: | - ( Prof. Dr. M. Seeberger, Head of Cardiothoracic of Anaesthesia ) |
| Study ID Numbers: | 129/03 |
| Study First Received: | February 2, 2006 |
| Last Updated: | March 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00286572 History of Changes |
| Health Authority: | Switzerland: Swissmedic |
|
insulin-dependent diabetes mellitus non-insulin-dependent diabetes mellitus coronary artery disease long-term mortality |
|
Arterial Occlusive Diseases Heart Diseases Metabolic Diseases Myocardial Ischemia Diabetes Mellitus Vascular Diseases Endocrine System Diseases Diabetes Mellitus Type 1 Ischemia |
Arteriosclerosis Insulin Coronary Disease Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Coronary Artery Disease |
|
Arterial Occlusive Diseases Heart Diseases Metabolic Diseases Myocardial Ischemia Diabetes Mellitus Vascular Diseases Endocrine System Diseases |
Arteriosclerosis Coronary Disease Diabetes Mellitus, Type 2 Cardiovascular Diseases Glucose Metabolism Disorders Coronary Artery Disease |
