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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dong-Ju Choi, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01538771
First received: February 15, 2012
Last updated: June 18, 2015
Last verified: June 2015
  Purpose

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

Condition Intervention Phase
Myocardial Infarction
Drug: Darbepoetin alfa
Drug: Control Saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of IntraCoronary Erythropoietin Delivery BEfore Reperfusion: Gauging Infarct Size in Patients With Acute ST-segment Elevation Myocardial Infarction (ICEBERG).

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Peak CK-MB/ Troponin-I levels [ Time Frame: baseline, 6, 12,18,24,36,48hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Infarct size, area at risk and proportion of salvaged myocardium [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 days ] [ Designated as safety issue: No ]
    Assessed by cardiac MRI

  • Pathologic left ventricle remodeling assessed by cardiac MRI [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Between four days and 4 months ] [ Designated as safety issue: No ]
  • Composites of cardiovascular endpoints [ Time Frame: 4 Months ] [ Designated as safety issue: Yes ]
    ccardiac death, nonfatal myocardial infarction, stent thrombosis, ischemic stroke, hospital readmission with heart failure or ischemic symptoms, bleeding and target lesion revascularization


Enrollment: 80
Study Start Date: November 2009
Study Completion Date: February 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control group
Received same volume of saline
Drug: Control Saline
Same volume of saline intracoronary bolus infusion via over-the-wire balloon before the 1st ballooning and conventional treatment
Other Name: 0.9% normal saline
Active Comparator: Darbepoetin group
Darbepoetin alfa 300ug intracoronary bolus infusion via over-the-wire balloon before the 1st ballooning & conventional treatment
Drug: Darbepoetin alfa
Darbepoetin alfa 300ug intracoronary bolus infusion via over-the-wire balloon before the 1st ballooning and conventional treatment
Other Name: Nesp PFS Prefilled Syringe (Jeilkirin Pharm. Korea)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01538771

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of, 463707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Dong-Ju Choi, MD, PhD Seoul National University Bundang Hospital
  More Information

No publications provided by Seoul National University Bundang Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dong-Ju Choi, Principal Investigator, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01538771     History of Changes
Other Study ID Numbers: DAMI
Study First Received: February 15, 2012
Last Updated: June 18, 2015
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Bundang Hospital:
Myocardial infarction
Erythropoietin
Myocardial reperfusion injury

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Darbepoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 30, 2015