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Clinical Trials/NCT02874508
NCT02874508
Completed
Not Applicable

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

University Hospital Heidelberg1 site in 1 country40 target enrollmentAugust 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Elective Non-cardiac Surgery
Sponsor
University Hospital Heidelberg
Enrollment
40
Locations
1
Primary Endpoint
Composite Endpoint
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
December 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Johann Motsch

Prof. Dr.

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 leukocytosis
  • Current aplasia or leukopenia
  • Current GM-CSF treatment
  • Carotid artery surgery

Outcomes

Primary Outcomes

Composite Endpoint

Time Frame: 30 days postoperative

Composite of: cardiac death, myocardial ischemia, myocardial infarction, embolic or thrombotic stroke, congestive heart failure, serious cardiac arrhythmia

Secondary Outcomes

  • New onset atrial fibrillation(30 days postoperative)
  • Individual components of the composite endpoint(30 days postoperative)
  • Acute kidney injury(30 days postoperative)
  • Myocardial injury after non-cardiac surgery(30 days postoperative)
  • Peripheral vascular occlusion(30 days postoperative)

Study Sites (1)

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