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Completed

NCT Number: NCT02874508

Leukocytes and Perioperative Cardio Vascular Events

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology, University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Individual components of the composite endpoint

    Time frame: 30 days postoperative

  2. Peripheral vascular occlusion

    Time frame: 30 days postoperative

  3. New onset atrial fibrillation

    Time frame: 30 days postoperative

  4. Acute kidney injury

    Time frame: 30 days postoperative

  5. Myocardial injury after non-cardiac surgery

    Time frame: 30 days postoperative

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Registry information

Official study title

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

Acronym: LeukoCAPE

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 22, 2016
Registry last updated
Mar 29, 2017

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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