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Elective Non-cardiac SurgeryLeukoCAPENCT02874508

Leukocytes and Perioperative Cardio Vascular Events

An observational study of Elective Non-cardiac Surgery, run by University Hospital Heidelberg at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Elective Non-cardiac Surgery
How many people
40 participants
Where
1 siteGermany
Study dates
Aug 2016to Dec 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients admitted to University Hospital Heidelberg suffering coronary heart disease and scheduled for non-cardiac surgery

Who may be able to join

  • 18 years or older
  • Coronary heart disease
  • Non-cardiac surgery
  • Inpatient treatment
  • Informed consent

Who cannot join

  • 17 years of age or younger
  • Known pregnancy or breastfeeding
  • Missing informed consent
  • Ambulatory or day-case surgery
  • Emergency surgery
  • Acute or chronic leukemia
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Department of Anesthesiology, University Hospital Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

Other trials in Germany

About this study

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

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.

Read the 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.

Keywords
leukocyte subpopulations, perioperative myocardial infarction, non-cardiac surgery, perioperative cardiovascular risk

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite Endpoint

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

    Measured: 30 days postoperative

Secondary outcomes (5)

  1. Individual components of the composite endpoint

    Measured: 30 days postoperative

  2. Peripheral vascular occlusion

    Measured: 30 days postoperative

  3. New onset atrial fibrillation

    Measured: 30 days postoperative

  4. Acute kidney injury

    Measured: 30 days postoperative

  5. Myocardial injury after non-cardiac surgery

    Measured: 30 days postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02874508
Sponsor's protocol ID
LeukoKAPE01
Acronym
LeukoCAPE
Status last verified
Mar 2017
First submitted
17 Aug 2016
Last updated
29 Mar 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Rogacev KS, Cremers B, Zawada AM, Seiler S, Binder N, Ege P, Grosse-Dunker G, Heisel I, Hornof F, Jeken J, Rebling NM, Ulrich C, Scheller B, Bohm M, Fliser D, Heine GH. CD14++CD16+ monocytes independently predict cardiovascular events: a cohort study of 951 patients referred for elective coronary angiography. J Am Coll Cardiol. 2012 Oct 16;60(16):1512-20. doi: 10.1016/j.jacc.2012.07.019. Epub 2012 Sep 19.

    PubMed 22999728

  • Berg KE, Ljungcrantz I, Andersson L, Bryngelsson C, Hedblad B, Fredrikson GN, Nilsson J, Bjorkbacka H. Elevated CD14++CD16- monocytes predict cardiovascular events. Circ Cardiovasc Genet. 2012 Feb 1;5(1):122-31. doi: 10.1161/CIRCGENETICS.111.960385. Epub 2012 Jan 11.

    PubMed 22238190

  • Devereaux PJ, Xavier D, Pogue J, Guyatt G, Sigamani A, Garutti I, Leslie K, Rao-Melacini P, Chrolavicius S, Yang H, Macdonald C, Avezum A, Lanthier L, Hu W, Yusuf S; POISE (PeriOperative ISchemic Evaluation) Investigators. Characteristics and short-term prognosis of perioperative myocardial infarction in patients undergoing noncardiac surgery: a cohort study. Ann Intern Med. 2011 Apr 19;154(8):523-8. doi: 10.7326/0003-4819-154-8-201104190-00003.

    PubMed 21502650

  • Devereaux PJ, Sessler DI. Cardiac Complications in Patients Undergoing Major Noncardiac Surgery. N Engl J Med. 2015 Dec 3;373(23):2258-69. doi: 10.1056/NEJMra1502824. No abstract available.

    PubMed 26630144

  • Engelbertsen D, Andersson L, Ljungcrantz I, Wigren M, Hedblad B, Nilsson J, Bjorkbacka H. T-helper 2 immunity is associated with reduced risk of myocardial infarction and stroke. Arterioscler Thromb Vasc Biol. 2013 Mar;33(3):637-44. doi: 10.1161/ATVBAHA.112.300871. Epub 2013 Jan 10.

    PubMed 23307873

  • Gillmann HJ, Meinders A, Grohennig A, Larmann J, Bunte C, Calmer S, Sahlmann B, Rustum S, Aper T, Lichtinghagen R, Koch A, Teebken OE, Theilmeier G. Perioperative levels and changes of high-sensitivity troponin T are associated with cardiovascular events in vascular surgery patients. Crit Care Med. 2014 Jun;42(6):1498-506. doi: 10.1097/CCM.0000000000000249.

    PubMed 24584063

  • Kotfis K, Biernawska J, Zegan-Baranska M, Zukowski M. Peripheral Blood Lymphocyte Subsets (CD4+, CD8+ T Cells, NK Cells) in Patients with Cardiovascular and Neurological Complications after Carotid Endarterectomy. Int J Mol Sci. 2015 May 4;16(5):10077-94. doi: 10.3390/ijms160510077.

    PubMed 25946343

  • Rogacev KS, Seiler S, Zawada AM, Reichart B, Herath E, Roth D, Ulrich C, Fliser D, Heine GH. CD14++CD16+ monocytes and cardiovascular outcome in patients with chronic kidney disease. Eur Heart J. 2011 Jan;32(1):84-92. doi: 10.1093/eurheartj/ehq371. Epub 2010 Oct 12.

    PubMed 20943670

  • Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR, Berry WR, Gawande AA. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet. 2008 Jul 12;372(9633):139-144. doi: 10.1016/S0140-6736(08)60878-8. Epub 2008 Jun 24.

    PubMed 18582931

  • Weiser TG, Haynes AB, Molina G, Lipsitz SR, Esquivel MM, Uribe-Leitz T, Fu R, Azad T, Chao TE, Berry WR, Gawande AA. Size and distribution of the global volume of surgery in 2012. Bull World Health Organ. 2016 Mar 1;94(3):201-209F. doi: 10.2471/BLT.15.159293.

    PubMed 26966331

  • Larmann J, Handke J, Scholz AS, Dehne S, Arens C, Gillmann HJ, Uhle F, Motsch J, Weigand MA, Janssen H. Preoperative neutrophil to lymphocyte ratio and platelet to lymphocyte ratio are associated with major adverse cardiovascular and cerebrovascular events in coronary heart disease patients undergoing non-cardiac surgery. BMC Cardiovasc Disord. 2020 May 18;20(1):230. doi: 10.1186/s12872-020-01500-6.

    PubMed 32423376

Questions about this trial

What is this clinical trial studying?

An observational study of Elective Non-cardiac Surgery, run by University Hospital Heidelberg at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Endpoint (time frame: 30 days postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02874508, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.

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