Ignite Creation Date:
2024-05-06 @ 12:16 AM
Last Modification Date:
2024-10-26 @ 10:47 AM
Study NCT ID:
NCT01538771
Status:
COMPLETED
Last Update Posted:
2015-06-19
First Post:
2012-02-15
Brief Title:
Intracoronary Darbepoetin-alpha to Reduce The Infarct Size and Post-Infarct Remodeling
Sponsor:
Seoul National University Bundang Hospital
Organization:
Seoul National University Bundang Hospital
Study Overview
Official Title:
The Efficacy of IntraCoronary Erythropoietin Delivery BEfore Reperfusion Gauging Infarct Size in Patients With Acute ST-segment Elevation Myocardial Infarction ICEBERG
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 baseline6h12hr18hr 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
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 baseline6h12hr18hr 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
1 Uncontrolled congestive heart failure Killip classes II and III or cardiogenic shock
2 History of malignancy
3 Serious hematological disease
4 Current infectious disease requiring antibiotic therapy
5 Baseline creatinine level 20 mgdL or dependence on dialysis
6 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
1 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
2 The proportion of area at risk AAR and salvaged myocardium calculated by formula AAR - Infarct size AAR X 100
3 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
4 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
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
1 Uncontrolled congestive heart failure Killip classes II and III or cardiogenic shock
2 History of malignancy
3 Serious hematological disease
4 Current infectious disease requiring antibiotic therapy
5 Baseline creatinine level 20 mgdL or dependence on dialysis
6 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
1 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
2 The proportion of area at risk AAR and salvaged myocardium calculated by formula AAR - Infarct size AAR X 100
3 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
4 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None