NCT02874508

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 22, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

4 months

First QC Date

August 17, 2016

Last Update Submit

March 28, 2017

Conditions

Elective Non-cardiac Surgery

Keywords

leukocyte subpopulationsperioperative myocardial infarctionnon-cardiac surgeryperioperative cardiovascular risk

Outcome Measures

Primary Outcomes (1)

  • Composite Endpoint

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

    30 days postoperative

Secondary Outcomes (5)

  • Individual components of the composite endpoint

    30 days postoperative

  • Peripheral vascular occlusion

    30 days postoperative

  • New onset atrial fibrillation

    30 days postoperative

  • Acute kidney injury

    30 days postoperative

  • Myocardial injury after non-cardiac surgery

    30 days postoperative

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Related Publications (11)

  • 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.

    PMID: 22999728BACKGROUND

  • 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.

    PMID: 22238190BACKGROUND

  • 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.

    PMID: 21502650BACKGROUND

  • 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.

    PMID: 26630144BACKGROUND

  • 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.

    PMID: 23307873BACKGROUND

  • 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.

    PMID: 24584063BACKGROUND

  • 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.

    PMID: 25946343BACKGROUND

  • 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.

    PMID: 20943670BACKGROUND

  • 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.

    PMID: 18582931BACKGROUND

  • 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.

    PMID: 26966331BACKGROUND

  • 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.

    PMID: 32423376DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

Study Officials

  • Johann Motsch, Prof. Dr.

    Department of Anethesiology, University Hospital Heidelberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

August 17, 2016

First Posted

August 22, 2016

Study Start

August 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 29, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)