Intracoronary Darbepoetin-alpha to Reduce The Infarct Size and Post-Infarct Remodeling

Myocardial Infarction Clinical Trial

Official title:

The Efficacy of IntraCoronary Erythropoietin Delivery BEfore Reperfusion: Gauging Infarct Size in Patients With Acute ST-segment Elevation Myocardial Infarction (ICEBERG).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01538771
• Other study ID #: DAMI
• Status: Completed
• Phase: Phase 2
• First received: February 15, 2012
• Last updated: June 18, 2015
• Start date: November 2009
• Est. completion date: February 2013

Study information

• Verified date: June 2015
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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-a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Darbepoetin alfa
Darbepoetin alfa 300ug intracoronary bolus infusion via over-the-wire balloon before the 1st ballooning and conventional treatment
• Control Saline
Same volume of saline intracoronary bolus infusion via over-the-wire balloon before the 1st ballooning and conventional treatment

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak CK-MB/ Troponin-I levels		baseline, 6, 12,18,24,36,48hrs	No
Secondary	Infarct size, area at risk and proportion of salvaged myocardium	Assessed by cardiac MRI	Participants will be followed for the duration of hospital stay, an expected average of 4 days	No
Secondary	Pathologic left ventricle remodeling assessed by cardiac MRI	Definition : Increase of end-diastolic volume of left ventricle >20%	4 months	No
Secondary	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	No
Secondary	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	4 Months	Yes