Myocardial Infarction Clinical Trial
Official title:
Effects of Oxygen Treatment on Mechanisms Involved in Ischemia-reperfusion Injury: A Single Center, Randomized, Controlled Pilot Study in Healthy Volunteers
Verified date | December 2017 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Oxygen treatment is widely used in acutely ill patients. In particular, oxygen treatment is
routinely used in acute coronary syndrome (ACS) patients with suspected acute myocardial
infarction and variably recommended in ACS-guidelines, despite very limited data supporting a
beneficial effect.
Immediate re-opening of the acutely occluded infarct-related bloodvessel via primary
percutaneous coronary intervention (PCI) is the treatment of choice to limit ischemic injury
in the setting of ST-elevation ACS (STE-ACS). However, the sudden re-initiation of blood flow
achieved with primary PCI can give rise to further damage, so-called reperfusion injury.
Ischemia and reperfusion associated myocardial injury (IR-injury) involves a wide range of
pathological processes. Vascular leakage, activation of cell death programs, transcriptional
reprogramming, no reflow phenomenon and innate and adaptive immune activation all contribute
to tissue damage, thereby determining the infarct size. The effect of oxygen treatment on
these pathological processes, on the extent of IR-injury and the final infarct size in
STE-ACS patients has not previously been studied.
ACS is characterized by a systemic inflammation with typical elevations of soluble
inflammatory markers as well as changes in white blood cells. The inflammatory reaction might
be considered helpful in restoring myocardial tissue structure and function, but on the other
hand it might worsen IR-injury by activating various pathological processes. In human
experimental studies, Salmonella typhi vaccine has been used to create a standardized model
of systemic inflammation and when administered to healthy volunteers the vaccination has not
been associated with any adverse events.
In an ongoing register randomized multicentre clinical trial, the DETO2X (Determination of
role of oxygen in suspected acute myocardial infarction) study, the effect of oxygen on
morbidity and mortality in ACS patients is being investigated. In a substudy of the
DETO2X-trial, the investigators have planned to evaluate the effect of oxygen treatment on
IR-injury in STE-ACS as assessed by biomarkers reflecting various aspects of the pathological
processes involved.
The presented study is an experimental pilot study performed in healthy volunteers with a
Salmonella typhi vaccine-induced inflammation with the purpose of studying effects of oxygen
treatment on biological systems involved in the pathogenesis of IR- injury.
Status | Completed |
Enrollment | 36 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Age 18-40 years - Male gender Exclusion Criteria: - Female gender - Not willing to participate - Not able to communicate or to understand study instructions - Participation in another on-going trial - Any chronic disease - Any acute disease within 30 days of study inclusion - Any regular or temporary medication within 15 days of study inclusion - Current smokers |
Country | Name | City | State |
---|---|---|---|
Sweden | Linköping University Hospital | Linköping |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | University Hospital, Linkoeping |
Sweden,
Cabello JB, Burls A, Emparanza JI, Bayliss S, Quinn T. Oxygen therapy for acute myocardial infarction. Cochrane Database Syst Rev. 2013 Aug 21;(8):CD007160. doi: 10.1002/14651858.CD007160.pub3. Review. Update in: Cochrane Database Syst Rev. 2016 Dec 19;12 :CD007160. — View Citation
Ekström M, Eriksson P, Tornvall P. Vaccination, a human model of inflammation, activates systemic inflammation but does not trigger proinflammatory gene expression in adipose tissue. J Intern Med. 2008 Dec;264(6):613-7. doi: 10.1111/j.1365-2796.2008.01998.x. — View Citation
Eltzschig HK, Eckle T. Ischemia and reperfusion--from mechanism to translation. Nat Med. 2011 Nov 7;17(11):1391-401. doi: 10.1038/nm.2507. Review. — View Citation
Hofmann R, James SK, Svensson L, Witt N, Frick M, Lindahl B, Östlund O, Ekelund U, Erlinge D, Herlitz J, Jernberg T. DETermination of the role of OXygen in suspected Acute Myocardial Infarction trial. Am Heart J. 2014 Mar;167(3):322-8. doi: 10.1016/j.ahj.2013.09.022. Epub 2013 Dec 19. — View Citation
Piper HM, Meuter K, Schäfer C. Cellular mechanisms of ischemia-reperfusion injury. Ann Thorac Surg. 2003 Feb;75(2):S644-8. Review. — View Citation
Shuvy M, Atar D, Gabriel Steg P, Halvorsen S, Jolly S, Yusuf S, Lotan C. Oxygen therapy in acute coronary syndrome: are the benefits worth the risk? Eur Heart J. 2013 Jun;34(22):1630-5. doi: 10.1093/eurheartj/eht110. Epub 2013 Apr 3. Review. — View Citation
Yellon DM, Hausenloy DJ. Myocardial reperfusion injury. N Engl J Med. 2007 Sep 13;357(11):1121-35. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma concentration levels over time of biomarkers of oxidative stress, apoptosis, inflammation and platelet aggregation | Venous blood samples will be collected at 3, 6 and 8 hours after baseline and plasmaconcentration analyzed for Interleukin (IL)-6 [pg/mL], CRP [mg/L], Isoprostane [pg/mL], Soluble TNF receptor 1 [pg/mL], Soluble TNF receptor 2 [pg/mL], Soluble Fas [pg/mL], Soluble Fas ligand (pg/mL], MMP-2 [ng/mL], TIMP-2 [ng/mL], Soluble P-selectin [ng/mL], Platelet factor (PF)-4 [ng/mL], Beta-thromboglobulin [ng/mL]. | Within 8hours from baseline |
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