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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University Medical Centre Groningen.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Radboud University
Information provided by:
University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT00691613
First received: June 3, 2008
Last updated: March 11, 2010
Last verified: March 2010
History of Changes
  Purpose

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.


Condition Intervention
Ischemia-Reperfusion Injury
Myocardial Infarction
 Drug: Epoetin alpha
Drug: NaCl

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

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • DNA polymorphisms affecting HO-1 and AMP-deaminase activity is assessed by DNA analysis. [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • The effect of EPO treatment on heme oxygenase activity as measured in blood and as CO concentration in exhaled air. [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • Maximal voluntary contraction and duration of the exercise during ischemia. [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: July 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
EPO
 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).
Other Name: Eprex
Placebo Comparator: 2
NaCl
 Drug: 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.
Other Name: Sodiumchloride, saline

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691613

Contacts
Contact: W. T. Ruifrok, MD +31 50 361 6161 ext 77758 w.t.ruifok@thorax.umcg.nl
Contact: R. A. de Boer, MD, PhD +31 50 361 6161 ext 12355 r.a.de.boer@thorax.umcg.nl

Locations
Netherlands
Clinical Research Centre Nijmegen Not yet recruiting
Nijmegen, Gelderland, Netherlands, 6500 HB
Principal Investigator: G. A. Rongen, MD, PhD            
Sponsors and Collaborators
University Medical Centre Groningen
Radboud University
Investigators
Study Chair: W. H. van Gilst, Prof, PhD University Medical Centre Groningen
Study Chair: P. Smits, Prof, MD, PhD University Medical Centre Nijmegen
Principal Investigator: W. T. Ruifrok, MD University Medical Centre Groningen
Study Director: G. A. Rongen, MD, PhD University Medical Centre Nijmegen
Study Director: D.J. van Veldhuisen, Prof, MD, PhD University Medical Centre Groningen
Principal Investigator: W. Oyen, Prof, MD, PhD University Medical Centre Nijmegen
Principal Investigator: R. A. de Boer, MD, PhD University Medical Centre Groningen
Principal Investigator: P.P. van Geel, MD, PhD University Medical Centre Groningen
Principal Investigator: R. A. Tio, MD, PhD University Medical Centre Groningen
  More Information

Additional Information:
Webpage of the University Medical Centre Groningen  This link exits the ClinicalTrials.gov site
Webpage of the Clinical Research Centre Nijmegen  This link exits the ClinicalTrials.gov site
Webpage of the University Medical Centre Nijmegen  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Prof. dr. W.H. van Gilst, University Medical Centre Groningen, Dept. of Cardiology
ClinicalTrials.gov Identifier: NCT00691613     History of Changes
Other Study ID Numbers: WTR-ECG-3, EudraCT 2007-001089-33
Study First Received: June 3, 2008
Last Updated: March 11, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University Medical Centre Groningen:
Apoptosis
Annexin
Hypoxia
Ischemia-Reperfusion Injury

Additional relevant MeSH terms:
Infarction
Ischemia
Myocardial Infarction
Reperfusion Injury
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Vascular Diseases
Postoperative Complications
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013