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Long-term Mortality in Diabetics Undergoing Major Surgery
This study has been completed.
Sponsor:
University Hospital, Basel, Switzerland
Information provided by (Responsible Party):
Daniel Bolliger, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00286572
First received: February 2, 2006
Last updated: March 9, 2015
Last verified: March 2015
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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: | Observational Model: Cohort Time Perspective: 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 |
Resource links provided by NLM:
Further study details as provided by Daniel Bolliger, University Hospital, Basel, Switzerland:
Primary Outcome Measures:
- Death and/or major adverse cardiac events [ Time Frame: 12 months after surgery ]
| Enrollment: | 380 |
| Study Start Date: | January 2004 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
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
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00286572
Please refer to this study by its ClinicalTrials.gov identifier: NCT00286572
Locations
| Switzerland | |
| University Hospital | |
| Basel, CH, Switzerland, 4000 | |
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
| Principal Investigator: | Miodrag Filipovic, PD Dr. | University Hospital, Basel, Switzerland |
More Information
| Responsible Party: | Daniel Bolliger, PD Dr. Daniel Bolliger, University Hospital, Basel, Switzerland |
| ClinicalTrials.gov Identifier: | NCT00286572 History of Changes |
| Other Study ID Numbers: |
129/03 |
| Study First Received: | February 2, 2006 |
| Last Updated: | March 9, 2015 |
Keywords provided by Daniel Bolliger, University Hospital, Basel, Switzerland:
|
insulin-dependent diabetes mellitus non-insulin-dependent diabetes mellitus coronary artery disease long-term mortality |
Additional relevant MeSH terms:
|
Diabetes Mellitus Coronary Artery Disease Heart Diseases Coronary Disease Myocardial Ischemia Diabetes Mellitus, Type 2 Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on September 21, 2017