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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2007-001089-33 |
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| Name | Class |
|---|---|
| Radboud University Medical Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | EPO |
|
| 2 | Placebo Comparator | NaCl |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epoetin alpha | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| DNA polymorphisms affecting HO-1 and AMP-deaminase activity is assessed by DNA analysis. | 4 hours | |
| The effect of EPO treatment on heme oxygenase activity as measured in blood and as CO concentration in exhaled air. | 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| W. T. Ruifrok, MD | Contact | +31 50 361 6161 | 77758 | w.t.ruifok@thorax.umcg.nl |
| R. A. de Boer, MD, PhD | Contact | +31 50 361 6161 | 12355 | r.a.de.boer@thorax.umcg.nl |
| Name | Affiliation | Role |
|---|---|---|
| W. H. van Gilst, Prof, PhD | University Medical Center Groningen | Study Chair |
| P. Smits, Prof, MD, PhD | University Medical Centre Nijmegen | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Centre Nijmegen | Nijmegen | Gelderland | 6500 HB | Netherlands |
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| Label | URL |
|---|---|
| Webpage of the University Medical Centre Nijmegen | View source |
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| ID | Term |
|---|---|
| D015427 | Reperfusion Injury |
| D009203 | Myocardial Infarction |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000068817 | Epoetin Alfa |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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|
| NaCl | Drug | 0.9% sodium chloride solution as placebo dosage is 10 ml, which will be administered in the same manner as the interventional medicinal product. |
|
|
| Maximal voluntary contraction and duration of the exercise during ischemia. | 10 minutes |
| W. T. Ruifrok, MD |
| University Medical Center Groningen |
| Principal Investigator |
| G. A. Rongen, MD, PhD | University Medical Centre Nijmegen | Study Director |
| D.J. van Veldhuisen, Prof, MD, PhD | University Medical Center Groningen | Study Director |
| W. Oyen, Prof, MD, PhD | University Medical Centre Nijmegen | Principal Investigator |
| R. A. de Boer, MD, PhD | University Medical Center Groningen | Principal Investigator |
| P.P. van Geel, MD, PhD | University Medical Center Groningen | Principal Investigator |
| R. A. Tio, MD, PhD | University Medical Center Groningen | Principal Investigator |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D009336 | Necrosis |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D002241 |
| Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |