An interventional study of Epoetin alpha and NaCl in Ischemia-Reperfusion Injury and Myocardial Infarction, sponsored by University Medical Center Groningen. Status unknown at 1 site in Netherlands. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-03-12.
Sponsored by University Medical Center Groningen · Not applicable, Interventional, and Basic science
Rationale:
The investigators hypothesize that EPO protects against apoptosis after acute ischemia in man and that it is detectable using the annexin-A5 model.
Objective:
Does infusion of a single dose of Epoetin Alfa, a short-acting EPO, protect against apoptosis in man after acute ischemia?
Study design:
A double blinded randomised cross-over study.
Study population:
12 Healthy male volunteers, between 18 and 40 years old.
Intervention:
All 12 volunteers will receive a single dose of EPO and placebo in a randomized order. A six week wash-out period is obtained in order to avoid interference of both treatments.
Main study parameters/endpoints:
The percentage of difference between radioactivity (quantified as counts per pixel) of the experimental and control thenar muscle at one and four hours after reperfusion.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's planned enrollment of 12 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
EPO
Drug: Epoetin alpha
NaCl
Drug: NaCl
The dosage (60.000 I/U Epoetin alpha) will be diluted in 10 ml of 0.9% sodium chloride solution and injected in a single dose intravenously in the dominant forearm (the non-dominant forearm will be used as ischemic model).
Also known as: Eprex
0.9% sodium chloride solution as placebo dosage is 10 ml, which will be administered in the same manner as the interventional medicinal product.
Also known as: Sodiumchloride, saline
The percentage of difference between radioactivity (quantified as counts per pixel) of the predefined area of interest of the experimental and control thenar muscle at one and four hours after reperfusion.
Time frame: 4 hours
DNA polymorphisms affecting HO-1 and AMP-deaminase activity is assessed by DNA analysis.
Time frame: 4 hours
The effect of EPO treatment on heme oxygenase activity as measured in blood and as CO concentration in exhaled air.
Time frame: 4 hours
Maximal voluntary contraction and duration of the exercise during ischemia.
Time frame: 10 minutes
This study is status unknown, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Medical Center Groningen