Long-term Mortality in Diabetics Undergoing Major Surgery

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.

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Key information

Conditions

Diabetes Mellitus Arterial Occlusive Diseases Arteriosclerosis Autoimmune Diseases Cardiovascular Diseases Coronary Artery Disease Coronary Disease Coronary Heart Disease Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Immune System Diseases Major Non-cardiac Surgery Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital

Basel, CH, 4000, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Death and/or major adverse cardiac events

Time frame: 12 months after surgery

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study 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

Important dates

Study start: 2004
Primary completion: 2009
Study completion: 2010
First posted: Feb 3, 2006
Registry last updated: Mar 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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