Acute Myocardial InfarctionPhase 4NCT00882466
The Effect of Erythropoietin at the Time of Reperfusion in Acute Myocardial Infarction
A Phase 4 study testing human recombinant erythropoietin in people with Acute Myocardial Infarction, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the effect of intravenous human recombinant erythropoietin on the reperfusion injury at primary percutaneous coronary intervention in patients with acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- human recombinant erythropoietin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2008to Feb 2009
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute myocardial infarction <12hr
- Age >18yrs
- First myocardial infarction
- culprit lesion : proximal to mid left anterior descending artery
- Baseline coronary flow : TIMI Grade 0~1
Who cannot join
- Patients with previous myocardial infarction
- History of thrombotic complication
- History of cerebral infarction
- Uncontrolled hypertension
- Increased hemoglobin level >17g/dL
- Patients with mechanical valve
- Cardiogenic shock
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam, 463-707
About this study
Official title: Phase 4 Study of the Effect of Human Recombinant Erythropoietin at the Time of Reperfusion in Patients With Acute Myocardial Infarction
The purpose of this study is to investigate the effect of intravenous human recombinant erythropoietin on the reperfusion injury at primary percutaneous coronary intervention in patients with acute myocardial infarction.
- Conditions
- Acute Myocardial Infarction
- Being tested
- human recombinant erythropoietin
- Keywords
- erythropoietin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human recombinant erythropoietinDrug
intravenous bolus injection of EPO (50unit/kg)
| Study group | Role | What they receive |
|---|---|---|
| PCI only | No intervention | primary PCI only |
| EPO | Experimental | Not described Receives: Drug: human recombinant erythropoietin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creatinine kinase (CK), creatinine kinase-MB (CK-MB)
Measured: 4hr, 8hr, 12hr, 24hr, 48hr, 72hr
Secondary outcomes (1)
Infarct size assessed by cardiac MRI
Measured: day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2009 (estimated)
- Study startMay 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Dong-Ju Choi, MD,PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882466
- Sponsor's protocol ID
- EPO in AMI
- Status last verified
- Apr 2009
- First submitted
- 15 Apr 2009
- Last updated
- 17 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Suh JW, Chung WY, Kim YS, Kim KI, Jeon EJ, Cho YS, Youn TJ, Chae IH, Kim CH, Choi DJ. The effect of intravenous administration of erythropoietin on the infarct size in primary percutaneous coronary intervention. Int J Cardiol. 2011 Jun 2;149(2):216-220. doi: 10.1016/j.ijcard.2010.02.002. Epub 2010 Mar 2.
PubMed 20199815
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of the Effect of Human Recombinant Erythropoietin at the Time of Reperfusion in Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00882466
- Acronym / sponsor ID
- EPO in AMI
- Conditions
- Acute Myocardial Infarction
- Keywords
- erythropoietin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 16 Apr 2009 (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.
The purpose of this study is to investigate the effect of intravenous human recombinant erythropoietin on the reperfusion injury at primary percutaneous coronary intervention in patients with acute myocardial infarction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCI only | No intervention | –primary PCI only |
| EPO | Experimental | Drug: human recombinant erythropoietin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Acute myocardial infarction <12hr
- Age >18yrs
- First myocardial infarction
- culprit lesion : proximal to mid left anterior descending artery
- Baseline coronary flow : TIMI Grade 0~1
Key exclusion criteria (7 listed)
- Patients with previous myocardial infarction
- History of thrombotic complication
- History of cerebral infarction
- Uncontrolled hypertension
- Increased hemoglobin level >17g/dL
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 |
|---|---|---|
| human recombinant erythropoietinintravenous bolus injection of EPO (50unit/kg) | Drug | EPO |
Primary outcome
Creatinine kinase (CK), creatinine kinase-MB (CK-MB)
Time frame: 4hr, 8hr, 12hr, 24hr, 48hr, 72hr
1 secondary outcome
Infarct size assessed by cardiac MRI
Time frame: day 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2009.
- Derived from this study: PubMed 20199815Suh JW, Chung WY, Kim YS, Kim KI, Jeon EJ, Cho YS, Youn TJ, Chae IH, Kim CH, Choi DJ. The effect of intravenous administration of erythropoietin on the infarct size in primary percutaneous coronary intervention. Int J Cardiol. 2011 Jun 2;149(2):216-220. doi: 10.1016/j.ijcard.2010.02.002. Epub 2010 Mar 2.
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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.
Dong-Ju Choi, MD,PhD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing human recombinant erythropoietin in people with Acute Myocardial Infarction, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 17 Apr 2009. 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 South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creatinine kinase (CK), creatinine kinase-MB (CK-MB) (time frame: 4hr, 8hr, 12hr, 24hr, 48hr, 72hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00882466, which also lists 1 linked publication.
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 17 Apr 2009.