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LeukoCAPE: Leukocytes and Perioperative Cardio Vascular Events

Sponsor
University Hospital Heidelberg (Other)
Overall Status
Completed
CT.gov ID
NCT02874508
Collaborator
(none)
40
Enrollment
1
Location
4
Actual Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    40 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Association of Circulating Leukocyte Subpopulations and Cardio Vascular Events in the Perioperative Period
    Actual Study Start Date :
    Aug 1, 2016
    Actual Primary Completion Date :
    Dec 1, 2016
    Actual Study Completion Date :
    Dec 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Composite Endpoint [30 days postoperative]

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

    Secondary Outcome Measures

    1. Individual components of the composite endpoint [30 days postoperative]

    2. Peripheral vascular occlusion [30 days postoperative]

    3. New onset atrial fibrillation [30 days postoperative]

    4. Acute kidney injury [30 days postoperative]

    5. Myocardial injury after non-cardiac surgery [30 days postoperative]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anesthesiology, University Hospital Heidelberg Heidelberg Baden-Württemberg Germany 69120

    Sponsors and Collaborators

    • University Hospital Heidelberg

    Investigators

    • Principal Investigator: Johann Motsch, Prof. Dr., Department of Anethesiology, University Hospital Heidelberg

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Johann Motsch, Prof. Dr., University Hospital Heidelberg
    ClinicalTrials.gov Identifier:
    NCT02874508
    Other Study ID Numbers:
    • LeukoKAPE01
    First Posted:
    Aug 22, 2016
    Last Update Posted:
    Mar 29, 2017
    Last Verified:
    Mar 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Johann Motsch, Prof. Dr., University Hospital Heidelberg
    leukocyte subpopulations
    perioperative myocardial infarction
    non-cardiac surgery
    perioperative cardiovascular risk

    Study Results

    No Results Posted as of Mar 29, 2017