Myocardial InfarctionPhase 2NCT01538771
Intracoronary Darbepoetin-alpha to Reduce The Infarct Size and Post-Infarct Remodeling
A Phase 2 study testing Darbepoetin alfa in people with Myocardial Infarction, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Prospective, randomized and open label trial Hypothesis Infusion of intracoronary darbepoetin-alpha at the time of reperfusion may reduce infarct size and post-infarct pathologic left ventricular remodeling in patients with ST-segment elevation myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Darbepoetin alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2009to Feb 2013
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ST-elevation myocardial infarction (MI) within 12 hours of onset
- Suitable coronary anatomy for PCI
- Age < 80 yrs
Who cannot join
- Uncontrolled congestive heart failure (Killip classes II and III, or cardiogenic shock)
- History of malignancy
- Serious hematological disease
- Current infectious disease requiring antibiotic therapy
- Baseline creatinine level > 2.0 mg/dL or dependence on dialysis
- Known hypersensitivity to or contraindication for heparin, aspirin, clopidogrel, sirolimus, everolimus, contrast medium and darbepoetin-α
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam, 463707
About this study
Official title: The Efficacy of IntraCoronary Erythropoietin Delivery BEfore Reperfusion: Gauging Infarct Size in Patients With Acute ST-segment Elevation Myocardial Infarction (ICEBERG).
Prospective, randomized and open label trial
Hypothesis
Read more
- Infusion of intracoronary darbepoetin-alpha at the time of reperfusion may reduce infarct size and post-infarct pathologic left ventricular remodeling in patients with ST-segment elevation myocardial infarction.
Methods
- Randomization into control group or treatment group
- Treatment group : Darbepoetin-alpha 300ug intracoronary bolus infusion via over-the-wire balloon system simultaneously with first balloon inflation and conventional treatment
- Control group : conventional treatment
Endpoints
- peak CK-MB \& troponin levels : baseline,6h,12hr,18hr, 24hr, 36hr and 48hr
- MRI at baseline : infarct size, area at risk and salvaged myocardium
- MRI at 4 months : prevalence of pathologic left ventricle remodeling (definition: increase of end-diastolic volume index > 20% compared to baseline)
- safety endpoint : cardiac death, nonfatal myocardial infarction, stent thrombosis, ischemic stroke, hospital readmission with heart failure or ischemic symptom, bleeding and urgent target lesion revascularization
Read the detailed description
[Eligibility Criteria]
- Patients, regardless of gender, at the age from 18 to 80 years were eligible if they had within 12 hours of onset of ST-segment myocardial infarction that was decided to treat with primary percutaneous coronary intervention.
[Exclusion criteria]
- Uncontrolled congestive heart failure (Killip classes II and III, or cardiogenic shock)
- History of malignancy
- Serious hematological disease
- Current infectious disease requiring antibiotic therapy
- Baseline creatinine level > 2.0 mg/dL or dependence on dialysis
- Known hypersensitivity to or contraindication for heparin, aspirin, clopidogrel, sirolimus, everolimus, contrast medium and darbepoetin-α
[Primary endpoint] Myocardial infarct size, estimated by measurement of peak levels of cardiac biomarker (CK-MB and troponin-I of the patients was followed for 48 hours at every 6 hours)
[Secondary end points]
- The infarct size, measured as the area of delayed enhancement seen with cardiac magnetic resonance (CMR) imaging on average four days after ST-segment elevation myocardial infarction (baseline)
- The proportion of area at risk (AAR) and salvaged myocardium, calculated by formula; [AAR - Infarct size] / AAR X 100 (%)
- The change of left ventricular ejection fraction (LVEF), LV end-diastolic volume (LVEDV), and LV end-systolic volume (LVESV) assessed by CMR between four days and four months
- LV remodeling index [(LVEDV at four months - baseline LVEDV) / baseline LVEDV X 100%] and the incidence of pathologic LV remodeling (LV remodeling index > 20%);
[Safety endpoints] The incidence of composites of the cardiovascular endpoints (cardiac death, nonfatal myocardial infarction, stent thrombosis, ischemic stroke, hospital readmission with heart failure or ischemic symptoms, bleeding and urgent target lesion revascularization) assessed at four months.
- Conditions
- Myocardial Infarction
- Being tested
- Darbepoetin alfa, Control Saline
- Keywords
- Myocardial infarction, Erythropoietin, Myocardial reperfusion injury
- Medical subject headings
- Myocardial Infarction, Myocardial Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darbepoetin alfaDrug
Also called Nesp PFS Prefilled Syringe (Jeilkirin Pharm. Korea)
Darbepoetin alfa 300ug intracoronary bolus infusion via over-the-wire balloon before the 1st ballooning and conventional treatment
Control SalineDrug
Also called 0.9% normal saline
Same volume of saline intracoronary bolus infusion via over-the-wire balloon before the 1st ballooning and conventional treatment
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Received same volume of saline Receives: Drug: Control Saline |
| Darbepoetin group | Active comparator | Darbepoetin alfa 300ug intracoronary bolus infusion via over-the-wire balloon before the 1st ballooning \& conventional treatment Receives: Drug: Darbepoetin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak CK-MB/ Troponin-I levels
Measured: baseline, 6, 12,18,24,36,48hrs
Secondary outcomes (4)
Infarct size, area at risk and proportion of salvaged myocardium
Assessed by cardiac MRI
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 days
Pathologic left ventricle remodeling assessed by cardiac MRI
Definition : Increase of end-diastolic volume of left ventricle >20%
Measured: 4 months
Change of left ventricular ejection fraction, LV end-diastolic volume , and LV end-systolic volume assessed by cardiac MRI
Measured: Between four days and 4 months
Composites of cardiovascular endpoints
ccardiac death, nonfatal myocardial infarction, stent thrombosis, ischemic stroke, hospital readmission with heart failure or ischemic symptoms, bleeding and target lesion revascularization
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (estimated)
- Study startNov 2009
- Primary completionSep 2012
- Study completionFeb 2013
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Ju Choi, Seoul National University Bundang Hospital
- Investigators
- Dong-Ju Choi, MD, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538771
- Sponsor's protocol ID
- DAMI
- Status last verified
- Jun 2015
- First submitted
- 15 Feb 2012
- Last updated
- 19 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Suh JW, Yoon YE, Oh IY, Yoon CH, Cho YS, Youn TJ, Chae IH, Choi DJ. A single-center prospective randomized controlled trial evaluating the safety and efficacy of IntraCoronary Erythropoietin delivery BEfore Reperfusion: gauging infarct size in patients with acute ST-segment elevation myocardial infarction. Study design and rationale of the 'ICEBERG Trial'. Contemp Clin Trials. 2013 May;35(1):145-50. doi: 10.1016/j.cct.2013.03.001. Epub 2013 Mar 16.
PubMed 23506972
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of IntraCoronary Erythropoietin Delivery BEfore Reperfusion: Gauging Infarct Size in Patients With Acute ST-segment Elevation Myocardial Infarction (ICEBERG).
- ClinicalTrials.gov ID
- NCT01538771
- Acronym / sponsor ID
- DAMI
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial infarction, Erythropoietin, Myocardial reperfusion injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 24 Feb 2012 (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.
Prospective, randomized and open label trial
Hypothesis
- Infusion of intracoronary darbepoetin-alpha at the time of reperfusion may reduce infarct size and post-infarct pathologic left ventricular remodeling in patients with ST-segment elevation myocardial infarction.
Methods
- Randomization into control group or treatment group
- Treatment group : Darbepoetin-alpha 300ug intracoronary bolus infusion via over-the-wire balloon system simultaneously with first balloon inflation and conventional treatment
- Control group : conventional treatment
Endpoints
- peak CK-MB \& troponin levels : baseline,6h,12hr,18hr, 24hr, 36hr and 48hr
- MRI at baseline : infarct size, area at risk and salvaged myocardium
- MRI at 4 months : prevalence of pathologic left ventricle remodeling (definition: increase of end-diastolic volume index > 20% compared to baseline)
- safety endpoint : cardiac death, nonfatal myocardial infarction, stent thrombosis, ischemic stroke, hospital readmission with heart failure or ischemic symptom, bleeding and urgent target lesion revascularization
Detailed description
[Eligibility Criteria]
- Patients, regardless of gender, at the age from 18 to 80 years were eligible if they had within 12 hours of onset of ST-segment myocardial infarction that was decided to treat with primary percutaneous coronary intervention.
[Exclusion criteria]
- Uncontrolled congestive heart failure (Killip classes II and III, or cardiogenic shock)
- History of malignancy
- Serious hematological disease
- Current infectious disease requiring antibiotic therapy
- Baseline creatinine level > 2.0 mg/dL or dependence on dialysis
- Known hypersensitivity to or contraindication for heparin, aspirin, clopidogrel, sirolimus, everolimus, contrast medium and darbepoetin-α
[Primary endpoint] Myocardial infarct size, estimated by measurement of peak levels of cardiac biomarker (CK-MB and troponin-I of the patients was followed for 48 hours at every 6 hours)
[Secondary end points]
- The infarct size, measured as the area of delayed enhancement seen with cardiac magnetic resonance (CMR) imaging on average four days after ST-segment elevation myocardial infarction (baseline)
- The proportion of area at risk (AAR) and salvaged myocardium, calculated by formula; [AAR - Infarct size] / AAR X 100 (%)
- The change of left ventricular ejection fraction (LVEF), LV end-diastolic volume (LVEDV), and LV end-systolic volume (LVESV) assessed by CMR between four days and four months
- LV remodeling index [(LVEDV at four months - baseline LVEDV) / baseline LVEDV X 100%] and the incidence of pathologic LV remodeling (LV remodeling index > 20%);
[Safety endpoints] The incidence of composites of the cardiovascular endpoints (cardiac death, nonfatal myocardial infarction, stent thrombosis, ischemic stroke, hospital readmission with heart failure or ischemic symptoms, bleeding and urgent target lesion revascularization) assessed at four months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Control SalineReceived same volume of saline |
| Darbepoetin group | Active comparator | Drug: Darbepoetin alfaDarbepoetin alfa 300ug intracoronary bolus infusion via over-the-wire balloon before the 1st ballooning \& conventional treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with ST-elevation myocardial infarction (MI) within 12 hours of onset
- Suitable coronary anatomy for PCI
- Age < 80 yrs
Key exclusion criteria (6 listed)
- Uncontrolled congestive heart failure (Killip classes II and III, or cardiogenic shock)
- History of malignancy
- Serious hematological disease
- Current infectious disease requiring antibiotic therapy
- Baseline creatinine level > 2.0 mg/dL or dependence on dialysis
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 |
|---|---|---|
| Darbepoetin alfaAlso: Nesp PFS Prefilled Syringe (Jeilkirin Pharm. Korea)Darbepoetin alfa 300ug intracoronary bolus infusion via over-the-wire balloon before the 1st ballooning and conventional treatment | Drug | Darbepoetin group |
| Control SalineAlso: 0.9% normal salineSame volume of saline intracoronary bolus infusion via over-the-wire balloon before the 1st ballooning and conventional treatment | Drug | Control group |
Primary outcome
Peak CK-MB/ Troponin-I levels
Time frame: baseline, 6, 12,18,24,36,48hrs
4 secondary outcomes
Infarct size, area at risk and proportion of salvaged myocardium
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 days
Pathologic left ventricle remodeling assessed by cardiac MRI
Time frame: 4 months
Change of left ventricular ejection fraction, LV end-diastolic volume , and LV end-systolic volume assessed by cardiac MRI
Time frame: Between four days and 4 months
Composites of cardiovascular endpoints
Time frame: 4 Months
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 19 Jun 2015.
- Derived from this study: PubMed 23506972Suh JW, Yoon YE, Oh IY, Yoon CH, Cho YS, Youn TJ, Chae IH, Choi DJ. A single-center prospective randomized controlled trial evaluating the safety and efficacy of IntraCoronary Erythropoietin delivery BEfore Reperfusion: gauging infarct size in patients with acute ST-segment elevation myocardial infarction. Study design and rationale of the 'ICEBERG Trial'. Contemp Clin Trials. 2013 May;35(1):145-50. doi: 10.1016/j.cct.2013.03.001. Epub 2013 Mar 16.
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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 2 study testing Darbepoetin alfa in people with 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 3 inclusion and 6 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 19 Jun 2015. 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. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Peak CK-MB/ Troponin-I levels (time frame: baseline, 6, 12,18,24,36,48hrs). 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 NCT01538771, 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 19 Jun 2015.