Intracoronary Darbepoetin-alpha to Reduce The Infarct Size and Post-Infarct Remodeling
The Efficacy of IntraCoronary Erythropoietin Delivery BEfore Reperfusion: Gauging Infarct Size in Patients With Acute ST-segment Elevation Myocardial Infarction (ICEBERG).
1 other identifier
interventional
80
1 country
1
Brief 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2009
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 15, 2012
CompletedFirst Posted
Study publicly available on registry
February 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedJune 19, 2015
June 1, 2015
2.8 years
February 15, 2012
June 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peak CK-MB/ Troponin-I levels
baseline, 6, 12,18,24,36,48hrs
Secondary Outcomes (4)
Infarct size, area at risk and proportion of salvaged myocardium
Participants will be followed for the duration of hospital stay, an expected average of 4 days
Pathologic left ventricle remodeling assessed by cardiac MRI
4 months
Change of left ventricular ejection fraction, LV end-diastolic volume , and LV end-systolic volume assessed by cardiac MRI
Between four days and 4 months
Composites of cardiovascular endpoints
4 Months
Study Arms (2)
Control group
PLACEBO COMPARATORReceived same volume of saline
Darbepoetin group
ACTIVE COMPARATORDarbepoetin alfa 300ug intracoronary bolus infusion via over-the-wire balloon before the 1st ballooning \& conventional treatment
Interventions
Darbepoetin alfa 300ug intracoronary bolus infusion via over-the-wire balloon before the 1st ballooning and conventional treatment
Same volume of saline intracoronary bolus infusion via over-the-wire balloon before the 1st ballooning and conventional treatment
Eligibility Criteria
You may qualify if:
- Patients with ST-elevation myocardial infarction (MI) within 12 hours of onset
- Suitable coronary anatomy for PCI
- Age \< 80 yrs
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam, 463707, South Korea
Related Publications (1)
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.
PMID: 23506972DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dong-Ju Choi, MD, PhD
Seoul National University Bundang Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 15, 2012
First Posted
February 24, 2012
Study Start
November 1, 2009
Primary Completion
September 1, 2012
Study Completion
February 1, 2013
Last Updated
June 19, 2015
Record last verified: 2015-06