- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01538771
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).
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
[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.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
-
Seongnam, Korea, Republikken, 463707
- Seoul National University Bundang Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Placebo komparator: Control group
Received same volume of saline
|
Same volume of saline intracoronary bolus infusion via over-the-wire balloon before the 1st ballooning and conventional treatment
Andre navn:
|
Aktiv komparator: Darbepoetin group
Darbepoetin alfa 300ug intracoronary bolus infusion via over-the-wire balloon before the 1st ballooning & conventional treatment
|
Darbepoetin alfa 300ug intracoronary bolus infusion via over-the-wire balloon before the 1st ballooning and conventional treatment
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Peak CK-MB/ Troponin-I levels
Tidsramme: baseline, 6, 12,18,24,36,48hrs
|
baseline, 6, 12,18,24,36,48hrs
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Infarct size, area at risk and proportion of salvaged myocardium
Tidsramme: Participants will be followed for the duration of hospital stay, an expected average of 4 days
|
Assessed by cardiac MRI
|
Participants will be followed for the duration of hospital stay, an expected average of 4 days
|
Pathologic left ventricle remodeling assessed by cardiac MRI
Tidsramme: 4 months
|
Definition : Increase of end-diastolic volume of left ventricle >20%
|
4 months
|
Change of left ventricular ejection fraction, LV end-diastolic volume , and LV end-systolic volume assessed by cardiac MRI
Tidsramme: Between four days and 4 months
|
Between four days and 4 months
|
|
Composites of cardiovascular endpoints
Tidsramme: 4 Months
|
ccardiac death, nonfatal myocardial infarction, stent thrombosis, ischemic stroke, hospital readmission with heart failure or ischemic symptoms, bleeding and target lesion revascularization
|
4 Months
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Dong-Ju Choi, MD, PhD, Seoul National University Bundang Hospital
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
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