Skip to main content
OpenTrials
Completed

NCT Number: NCT03105427

Leukocytes and Cardiovascular Perioperative Events-2

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Elective Non-cardiac Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anaesthesiology, University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

About this study

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.

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 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

Treatment and study plan

Primary outcomes

  1. 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

  1. Peripheral vascular occlusion

    Time frame: 30 days postoperative

    Diagnosed by a radiologist based on the results of duplex ultrasonography, angiography or CT-angiography.

  2. New onset atrial fibrillation

    Time frame: 30 days postoperative

    Number of participants with new electrocardiographic detection of atrial fibrillation in postoperative ECG and/or documented in patient charts

  3. Acute kidney injury

    Time frame: 30 days postoperative

    Number of participants with acute kidney injury according to KDIGO guidelines

  4. Congestive heart failure

    Time frame: 30 days postoperative

    Number of participants with congestive heart failure according to European Perioperative Clinical Outcome (EPCO) definitions

  5. Cardiac death

    Time frame: 30 days postoperative

    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

  6. Myocardial Ischemia

    Time frame: 30 days postoperative

    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

  7. Myocardial Infarction

    Time frame: 30 days postoperative

    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

  8. Myocardial Injury after Non-cardiac Surgery (MINS)

    Time frame: 30 days postoperative

    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

  9. Stroke

    Time frame: 30 days postoperative

    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

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Registry information

Official study title

Assoziationen Von Leukozyten-Sub-Populationen im Blut kardiovaskulärer Risikopatienten Mit Der Inzidenz Perioperativer kardiovaskulärer Ereignisse

Acronym: LeukoCAPE-2

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 10, 2017
Registry last updated
Jan 30, 2018

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.