Assoziationen Von Leukozyten-Sub-Populationen im Blut kardiovaskulärer Risikopatienten Mit Der Inzidenz Perioperativer kardiovaskulärer Ereignisse
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Elective Non-cardiac Surgery
- Sponsor
- University Hospital Heidelberg
- Enrollment
- 233
- Locations
- 1
- Primary Endpoint
- Cardiovascular Events
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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
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.
Investigators
Johann Motsch
Prof. Dr. med. habil.
University Hospital Heidelberg
Eligibility Criteria
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
Outcomes
Primary Outcomes
Cardiovascular Events
Time Frame: 30 days postoperative
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
Secondary Outcomes
- Peripheral vascular occlusion(30 days postoperative)
- New onset atrial fibrillation(30 days postoperative)
- Stroke(30 days postoperative)
- Congestive heart failure(30 days postoperative)
- Myocardial Ischemia(30 days postoperative)
- Myocardial Infarction(30 days postoperative)
- Cardiac death(30 days postoperative)
- Acute kidney injury(30 days postoperative)
- Myocardial Injury after Non-cardiac Surgery (MINS)(30 days postoperative)