Intracoronary Darbepoetin-alpha to Reduce The Infarct Size and Post-Infarct Remodeling
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Darbepoetin alfa
Control Saline
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring Myocardial infarction, Erythropoietin, Myocardial reperfusion injury
Eligibility Criteria
Inclusion Criteria:
- Patients with ST-elevation myocardial infarction (MI) within 12 hours of onset
- Suitable coronary anatomy for PCI
- Age < 80 yrs
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
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Control group
Darbepoetin group
Arm Description
Received same volume of saline
Darbepoetin alfa 300ug intracoronary bolus infusion via over-the-wire balloon before the 1st ballooning & conventional treatment
Outcomes
Primary Outcome Measures
Peak CK-MB/ Troponin-I levels
Secondary Outcome Measures
Infarct size, area at risk and proportion of salvaged myocardium
Assessed by cardiac MRI
Pathologic left ventricle remodeling assessed by cardiac MRI
Definition : Increase of end-diastolic volume of left ventricle >20%
Change of left ventricular ejection fraction, LV end-diastolic volume , and LV end-systolic volume assessed by cardiac MRI
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
Full Information
NCT ID
NCT01538771
First Posted
February 15, 2012
Last Updated
June 18, 2015
Sponsor
Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01538771
Brief Title
Intracoronary Darbepoetin-alpha to Reduce The Infarct Size and Post-Infarct Remodeling
Official Title
The Efficacy of IntraCoronary Erythropoietin Delivery BEfore Reperfusion: Gauging Infarct Size in Patients With Acute ST-segment Elevation Myocardial Infarction (ICEBERG).
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
Detailed Description
[Eligibility Criteria]
1. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Myocardial infarction, Erythropoietin, Myocardial reperfusion injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Received same volume of saline
Arm Title
Darbepoetin group
Arm Type
Active Comparator
Arm Description
Darbepoetin alfa 300ug intracoronary bolus infusion via over-the-wire balloon before the 1st ballooning & conventional treatment
Intervention Type
Drug
Intervention Name(s)
Darbepoetin alfa
Other Intervention Name(s)
Nesp PFS Prefilled Syringe (Jeilkirin Pharm. Korea)
Intervention Description
Darbepoetin alfa 300ug intracoronary bolus infusion via over-the-wire balloon before the 1st ballooning and conventional treatment
Intervention Type
Drug
Intervention Name(s)
Control Saline
Other Intervention Name(s)
0.9% normal saline
Intervention Description
Same volume of saline intracoronary bolus infusion via over-the-wire balloon before the 1st ballooning and conventional treatment
Primary Outcome Measure Information:
Title
Peak CK-MB/ Troponin-I levels
Time Frame
baseline, 6, 12,18,24,36,48hrs
Secondary Outcome Measure Information:
Title
Infarct size, area at risk and proportion of salvaged myocardium
Description
Assessed by cardiac MRI
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 4 days
Title
Pathologic left ventricle remodeling assessed by cardiac MRI
Description
Definition : Increase of end-diastolic volume of left ventricle >20%
Time Frame
4 months
Title
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
Title
Composites of cardiovascular endpoints
Description
ccardiac death, nonfatal myocardial infarction, stent thrombosis, ischemic stroke, hospital readmission with heart failure or ischemic symptoms, bleeding and target lesion revascularization
Time Frame
4 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with ST-elevation myocardial infarction (MI) within 12 hours of onset
Suitable coronary anatomy for PCI
Age < 80 yrs
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Ju Choi, MD, PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
463707
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
23506972
Citation
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.
Results Reference
derived
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Intracoronary Darbepoetin-alpha to Reduce The Infarct Size and Post-Infarct Remodeling
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