Infusion of a Single Dose of Erythropoietin to Prevent Injury in an Ischemia Reperfusion Forearm Model

Myocardial Infarction Clinical Trial

— IPIIR  

Official title:

Infusion of a Single Dose of Erythropoietin to Prevent Injury in an Ischemia Reperfusion Forearm Model - A Randomised Cross-over Study to Evaluate if Infusion of a Single Dose of EPO Protects Against Ischemia-reperfusion Injury in Man

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00691613
• Other study ID #: WTR-ECG-3
• Secondary ID: EudraCT 2007-001
• Status: Not yet recruiting
• Phase: N/A
• First received: June 3, 2008
• Last updated: March 11, 2010
• Start date: July 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2010
• Source: University Medical Center Groningen
• Contact: W. T. Ruifrok, MD
• Phone: +31 50 361 6161
• Email: w.t.ruifok[@]thorax.umcg.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers between 18 and 40 years of age

• male

• Volunteers are not allowed smoking 24 hours before the start of the experiment

Exclusion Criteria:

• Female

• Hypertension (SBP >140 mmHg, DBP >90 mmHg)

• Diabetes Mellitus (DM) (fasting glc >6.9 mmol/l, glc >11.0 mmol/l)

• Hypercholesterolemia

• Renal dysfunction (eGFR < 60 ml/min, calculated using MDRD formula)

• Any known hypersensitivity/allergic reaction to one of the constituents of Epoetin Alfa

• A history of use of any form of EPO

• Any current medication use

• Cardiovascular disease in medical history

• Smoking less than 24 hours prior to Epoetin alpha infusion

• Participation in research in the last 5 years in which any form of radioactivity was used

• No participation in any research trial in the last 30 days or 5 times the half-life of the used substance

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Ischemia
• Ischemia-Reperfusion Injury
• Myocardial Infarction
• Reperfusion Injury

Intervention

Drug:
• Epoetin alpha
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).
• NaCl
0.9% sodium chloride solution as placebo dosage is 10 ml, which will be administered in the same manner as the interventional medicinal product.

Locations

Country	Name	City	State
Netherlands	Clinical Research Centre Nijmegen	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	DNA polymorphisms affecting HO-1 and AMP-deaminase activity is assessed by DNA analysis.		4 hours	No
Secondary	The effect of EPO treatment on heme oxygenase activity as measured in blood and as CO concentration in exhaled air.		4 hours	No
Secondary	Maximal voluntary contraction and duration of the exercise during ischemia.		10 minutes	No

External Links

•   Webpage of the Clinical Research Centre Nijmegen
•   Webpage of the University Medical Centre Groningen
•   Webpage of the University Medical Centre Nijmegen