Leukocytes and Perioperative Cardio Vascular Events

Study Overview
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Brief Summary
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To analyze whether non-cardiac surgery in high-risk cardio-vascular patients induces a quantitative change in one or several leukocyte subpopulations and whether such changes are associated with perioperative cardio-vascular events.

Detailed Description
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Annually, there are more than 200 million surgeries worldwide (Weiser et al., 2016; Weiser et al., 2008). The POISE study revealed 5% of patients undergoing a non-cardiac surgery suffer perioperative myocardial infarcts going along with a perioperative mortality rate of about 11,6% (Devereaux et al., 2011). Possibilities to preoperatively identify patients at risk are limited (Devereaux und Sessler, 2015; Gillmann et al., 2014) and prophylactic interventions are not yet established or controversial (Devereaux und Sessler, 2015). Selected leukocyte subpopulations have been demonstrated to be associated with higher risk for cardiovascular events (Berg et al., 2012; Cheng et al., 2008; Engelbertsen et al., 2012; Kotfis et al., 2015; Rogacev et al., 2011; Rogacev et al., 2012).The aim of this study is to analyze whether surgical stress (non-cardiac surgery) induces a quantitative change in one or several of these leukocyte subpopulations and whether quantitative changes are associated with perioperative cardiovascular events. Therefore, high-risk cardio-vascular patients scheduled for non-cardiac surgery will be recruited. Blood will be drawn at predefined time points before surgery and up to three days postoperatively. Leukocytes will be analyzed by flow cytometry. During 30 day follow up adverse cardiovascular events will be recorded. ECGs will be recorded preoperatively and on post-OP day 3. High-sensitive cardiac Troponin T will be measured prior to the operation and on post-OP day one to three. The patient chart will be screened for cardio vascular events up to day 30. A telephone interview will be performed to detect cardiovascular events after discharge until post-OP day 30.

Official Title
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Association of Circulating Leukocyte Subpopulations and Cardio Vascular Events in the Perioperative Period

Conditions
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Elective Non-cardiac Surgery

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Coronary heart disease Non-cardiac surgery Inpatient treatment Informed consent Exclusion Criteria: 17 years of age or younger Known pregnancy or breastfeeding Missing informed consent Ambulatory or day-case surgery Emergency surgery Acute or chronic leukemia Current leukocytosis Current aplasia or leukopenia Current GM-CSF treatment Carotid artery surgery History of splenectomy or indications of splenectomy Cortisone treatment within past 14 days History of organ transplantation Current immunosuppressive medication Chemotherapy completed less than 14 days ago Intraoperative dexamethasone application Entity which is part of the composite endpoint diagnosed within past 28 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Endpoint | Composite of: cardiac death, myocardial ischemia, myocardial infarction, embolic or thrombotic stroke, congestive heart failure, serious cardiac arrhythmia | 30 days postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual components of the composite endpoint |  | 30 days postoperative | 
| Peripheral vascular occlusion |  | 30 days postoperative | 
| New onset atrial fibrillation |  | 30 days postoperative | 
| Acute kidney injury |  | 30 days postoperative | 
| Myocardial injury after non-cardiac surgery |  | 30 days postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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leukocyte subpopulations, perioperative myocardial infarction, non-cardiac surgery, perioperative cardiovascular risk