Intracoronary Darbepoetin-alpha to Reduce The Infarct Size and Post-Infarct Remodeling
- Conditions
- Myocardial Infarction
- Interventions
- Drug: Control Saline
- Registration Number
- NCT01538771
- Lead Sponsor
- Seoul National University Bundang Hospital
- 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.
\[Exclusion criteria\]
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 \> 2.0 mg/dL 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- Patients with ST-elevation myocardial infarction (MI) within 12 hours of onset
- Suitable coronary anatomy for PCI
- Age < 80 yrs
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Control Saline Received same volume of saline Darbepoetin group Darbepoetin alfa Darbepoetin alfa 300ug intracoronary bolus infusion via over-the-wire balloon before the 1st ballooning \& conventional treatment
- Primary Outcome Measures
Name Time Method Peak CK-MB/ Troponin-I levels baseline, 6, 12,18,24,36,48hrs
- Secondary Outcome Measures
Name Time Method 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 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 Assessed by cardiac MRI
Pathologic left ventricle remodeling assessed by cardiac MRI 4 months Definition : Increase of end-diastolic volume of left ventricle \>20%
Composites of cardiovascular endpoints 4 Months ccardiac death, nonfatal myocardial infarction, stent thrombosis, ischemic stroke, hospital readmission with heart failure or ischemic symptoms, bleeding and target lesion revascularization
Trial Locations
- Locations (1)
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of