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Long-term Mortality in Diabetics Undergoing Major Surgery

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ClinicalTrials.gov Identifier: NCT00286572
Recruitment Status : Completed
First Posted : February 3, 2006
Last Update Posted : March 10, 2015
Sponsor:
Information provided by (Responsible Party):
Daniel Bolliger, University Hospital, Basel, Switzerland

Study Description
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Brief Summary:
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 or disease
Diabetes Mellitus Coronary Heart Disease Major Non-cardiac Surgery

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 Design
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Study Type : Observational
Actual Enrollment : 380 participants
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
Study Start Date : January 2004
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2010

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Death and/or major adverse cardiac events [ Time Frame: 12 months after surgery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00286572


Locations
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Switzerland
University Hospital
Basel, CH, Switzerland, 4000
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Miodrag Filipovic, PD Dr. University Hospital, Basel, Switzerland
More Information
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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
First Posted: February 3, 2006    Key Record Dates
Last Update Posted: March 10, 2015
Last Verified: March 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:
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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