Ischemia-Reperfusion InjuryIPIIRNCT00691613
Infusion of a Single Dose of Erythropoietin to Prevent Injury in an Ischemia Reperfusion Forearm Model
A study testing Epoetin alpha and NaCl in people with Ischemia-Reperfusion Injury and Myocardial Infarction, run by University Medical Center Groningen at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ischemia-Reperfusion Injury, Myocardial Infarction
- What is being tested?
- Epoetin alpha and NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers between 18 and 40 years of age
- male
- Volunteers are not allowed smoking 24 hours before the start of the experiment
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Clinical Research Centre Nijmegen
Nijmegen, Gelderland, 6500 HB
G. A. Rongen, MD, PhD
About this study
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
Rationale:
The investigators hypothesize that EPO protects against apoptosis after acute ischemia in man and that it is detectable using the annexin-A5 model.
Read more
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.
- Conditions
- Ischemia-Reperfusion Injury, Myocardial Infarction
- Being tested
- Epoetin alpha, NaCl
- Keywords
- Apoptosis, Annexin, Hypoxia, Ischemia-Reperfusion Injury
- Medical subject headings
- Reperfusion Injury, Myocardial Infarction, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin alphaDrug
Also called Eprex
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).
NaClDrug
Also called Sodiumchloride, saline
0.9% sodium chloride solution as placebo dosage is 10 ml, which will be administered in the same manner as the interventional medicinal product.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | EPO Receives: Drug: Epoetin alpha |
| 2 | Placebo comparator | NaCl Receives: Drug: NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 hours
Secondary outcomes (3)
DNA polymorphisms affecting HO-1 and AMP-deaminase activity is assessed by DNA analysis.
Measured: 4 hours
The effect of EPO treatment on heme oxygenase activity as measured in blood and as CO concentration in exhaled air.
Measured: 4 hours
Maximal voluntary contraction and duration of the exercise during ischemia.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startJul 2010
- Primary completionOct 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemia-Reperfusion InjuryStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center
- Investigators
- W. H. van Gilst, Prof, PhD, Study chair, University Medical Center GroningenP. Smits, Prof, MD, PhD, Study chair, University Medical Centre NijmegenW. T. Ruifrok, MD, Principal investigator, University Medical Center GroningenG. A. Rongen, MD, PhD, Study director, University Medical Centre NijmegenD.J. van Veldhuisen, Prof, MD, PhD, Study director, University Medical Center GroningenW. Oyen, Prof, MD, PhD, Principal investigator, University Medical Centre NijmegenR. A. de Boer, MD, PhD, Principal investigator, University Medical Center GroningenP.P. van Geel, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691613
- Sponsor's protocol ID
- WTR-ECG-3
- Other IDs
- EudraCT 2007-001089-33
- Acronym
- IPIIR
- Status last verified
- Mar 2010
- First submitted
- 3 Jun 2008
- Last updated
- 12 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00691613
- Acronym / sponsor ID
- IPIIR / WTR-ECG-3
- Conditions
- Ischemia-Reperfusion Injury, Myocardial Infarction
- Keywords
- Apoptosis, Annexin, Hypoxia, Ischemia-Reperfusion Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Radboud University Medical Center
- Study start
- Jul 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 5 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Epoetin alphaEPO |
| 2 | Placebo comparator | Drug: NaClNaCl |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy volunteers between 18 and 40 years of age
- male
- Volunteers are not allowed smoking 24 hours before the start of the experiment
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epoetin alphaAlso: EprexThe 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). | Drug | 1 |
| NaClAlso: Sodiumchloride, saline0.9% sodium chloride solution as placebo dosage is 10 ml, which will be administered in the same manner as the interventional medicinal product. | Drug | 2 |
Primary outcome
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
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2010.
- Webpage of the University Medical Centre NijmegenLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
W. H. van Gilst, Prof, PhD study chair
University Medical Center Groningen
P. Smits, Prof, MD, PhD study chair
University Medical Centre Nijmegen
W. T. Ruifrok, MD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epoetin alpha and NaCl in people with Ischemia-Reperfusion Injury and Myocardial Infarction, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact W. T. Ruifrok, MD (+31 50 361 6161 ext. 77758, w.t.ruifok@thorax.umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2010.