Leukocytes and Perioperative Cardio Vascular Events

NCT ID: NCT02874508

Last Updated: 2017-03-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2016-12-31

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.

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.

Conditions

Elective Non-cardiac Surgery

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Heidelberg

OTHER

Sponsor Role: lead

Responsible Party

Johann Motsch

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Johann Motsch, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Anethesiology, University Hospital Heidelberg

Locations

Department of Anesthesiology, University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 22999728 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22238190 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21502650 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26630144 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23307873 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24584063 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25946343 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20943670 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18582931 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26966331 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32423376 (View on PubMed)

Other Identifiers

LeukoKAPE01

Identifier Type: -

Identifier Source: org_study_id