Leukocytes and Cardiovascular Perioperative Events-2

Study Overview
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Brief Summary
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The potential use of regulatory T cells as preoperative risk stratification tool is evaluated in order to improve clinical risk stratification and reduce perioperative morbidity and mortality.

Detailed Description
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Annually, there are more than 200 million surgeries worldwide. 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%. Possibilities to preoperatively identify patients at risk are limited and prophylactic interventions are not yet established or controversial. Selected leukocyte subpopulations have been demonstrated to be associated with higher risk for cardiovascular events. The aim of this study is to evaluate the potential use of regulatory T cells as preoperative risk stratification tool in order to improve clinical risk stratification and reduce perioperative morbidity and mortality. Therefore, high-risk cardiovascular patients scheduled for major 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 cardiovascular 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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Assoziationen Von Leukozyten-Sub-Populationen im Blut kardiovaskulärer Risikopatienten Mit Der Inzidenz Perioperativer kardiovaskulärer Ereignisse

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 aplasia or leukopenia Current GM-CSF treatment Carotid artery surgery History of splenectomy Current intravenous or oral Cortisone treatment History of organ transplantation Current immunosuppressive medication Chemotherapy completed less than 14 days ago 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 |
| --- | --- | --- |
| Cardiovascular Events | Number of participants with Cardiovascular Events defined as occurrence of Cardiac Death and/or Myocardial Ischemia and/or Myocardial Infarction and/or Myocardial Injury After Non-cardiac Surgery (MINS) and/or Embolic Stroke and/or Thrombotic Stroke recorded until postoperative day 30. Definitions according to European Perioperative Clinical Outcome-(EPCO) definitions detected at postoperative visits, documented in patient chart or detected during telephone interview after 30 postoperative days | 30 days postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral vascular occlusion | Diagnosed by a radiologist based on the results of duplex ultrasonography, angiography or CT-angiography. | 30 days postoperative | 
| New onset atrial fibrillation | Number of participants with new electrocardiographic detection of atrial fibrillation in postoperative ECG and/or documented in patient charts | 30 days postoperative | 
| Acute kidney injury | Number of participants with acute kidney injury according to KDIGO guidelines | 30 days postoperative | 
| Congestive heart failure | Number of participants with congestive heart failure according to European Perioperative Clinical Outcome (EPCO) definitions | 30 days postoperative | 
| Cardiac death | Number of participants with cardiac Death defined as death because of new myocardial infarction or ischemia, or atrial or ventricular arrhythmias, or cardiogenic pulmonary edema, or pulmonary embolism detected at postoperative visits, documented in patient chart or detected during telephone interview after 30 postoperative days | 30 days postoperative | 
| Myocardial Ischemia | Number of participants with myocardial ischemia defined as new electrocardiographic detection of myocardial ischemia in ECG and/or documented in patient charts which will be screened up to 30 postoperative days and/or detected during telephone interview after 30 postoperative days | 30 days postoperative | 
| Myocardial Infarction | Number of participants with Myocardial Infarction defined as an increase in serum cardiac biomarker values in combination with symptoms of ischemia or new/presumed new significant ST segment or T wave ECG changes or new left bundle branch block or development of pathological Q waves on ECG. Definition according to European Perioperative Clinical Outcome-(EPCO) definitions detected at postoperative visits, postoperative blood analyses, documented in patient chart or detected during telephone interview after 30 postoperative days | 30 days postoperative | 
| Myocardial Injury after Non-cardiac Surgery (MINS) | Number of participants with MINS defined as raise in postoperative hs-cTNT (high sensitivity cardiac troponin T) jugded due to myocardial ischemia detected at postoperative visits, documented in patient chart or detected during telephone interview after 30 postoperative days | 30 days postoperative | 
| Stroke | Number of participants with embolic or thrombotic stroke defined cerebral event with persistent residual motor, sensory or cognitive dysfunction detected at postoperative visits, documented in patient chart or detected during telephone interview after 30 postoperative days | 30 days postoperative |