Erythropoietin in Acute Myocardial Infarction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Hammersmith Hospitals NHS Trust.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hammersmith Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00149058
First received: September 6, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

Erythropoietin (EPO) is a naturally occuring hormone which regulates the body's response to lack of oxygen and controls the number of red cells in the blood. Recent studies in animals have shown that EPO has protective effects when organs such as the heart and brain are injured by lack of oxygen due to reduced blood supply.

We wish to test the idea that giving a patient, who is having a heart attack, an injection of EPO will reduce the size of the heart attack.


Condition Intervention Phase
Acute Myocardial Infarction
Drug: Erythropoietin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase II Randomised Trial to Investigate the Safety and Efficacy of Recombinant Human Erythropoietin on Infarct Size in Patients Undergoing Primary Percutaneous Coronary Angioplasty for ST-Segment Elevation Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Hammersmith Hospitals NHS Trust:

Primary Outcome Measures:
  • Myocardial infarct size

Secondary Outcome Measures:
  • Death
  • Reinfarction

Estimated Enrollment: 124
Study Start Date: October 2005
Estimated Study Completion Date: January 2008
Detailed Description:

We wish to perform a randomised double-blind, placebo-controlled clinical trial to examine the effects of EPO given at the time of primary angioplasty for acute myocardial infarction (MI) on myocardial infarct size. In this trial the null hypothesis is that there is no effect of EPO on myocardial infarct size, the alternative hypothesis is that EPO reduces myocardial infarct size.

124 subjects with acute ST-elevation MI who fulfil the inclusion/exclusion criteria and give informed consent to participate in the study will be recruited from patients referred to the cardiac catheterisation laboratories at the Hammersmith Hospital and King's College Hospital. Subjects will undergo primary percutaneous coronary angioplasty (primary PCI) according to standard clinical protocols. Subjects will be randomised to either placebo or EPO at the time of primary PCI. EPO will be given as a bolus of 12ml containing 33,000U over 30 mins via a peripheral vein followed by an infusion of 24ml containing 67,000 U over 12 hours. Placebo will be identical to EPO without the active ingredient. After the PCI subjects will receive standard care on the coronary care unit. An additional 20ml of blood will be taken each day at the time of routine clinical venesection for storage and subjects will have gadolinium enhanced cardiovascular magnetic resonance (CMR) performed before discharge to evaluate infarct size. Follow-up will be performed at 30 days (clinical, ECG and 20ml blood sample) and at 90 days (clinical, ECG and CMR scan and blood sample). The study will end at 90 days and patients will continue with standard clinical care under the direction of a consultant cardiologist.

CMR will be performed in the Robert Steiner MR Unit/Imaging Department, Hammersmith Hospital using a 1.5 tesla scanner according to standard protocols. Each scan will last about 1h and information will be collected on tissue characteristics, left ventricular function, wall motion abnormalities, myocardial perfusion. Myocardial infarcts will be detected by late contrast gadolinium enhancement. Gadolinium will be used at doses up to 0.2mmol/kg and is safe with an incidence of mild and transient side effects including headache and nausea of ~1%. Scans will be performed with under continuous ECG monitoring with a doctor and at least 1 other person present. Resuscitation facilities will be available at all times and the MRI facility is covered by an experienced 24 hour a day cardiac arrest team.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female >18 years of age
  • Weight between 50 kg and 120 kg
  • Suspected of having his/her first-documented STEMI
  • Symptoms of ischemia of >20 min with < 6h prior to PCI
  • Either 1mm ST elevation in at least two contiguous limb leads or >2mm ST elevation in 2 contiguous chest leads
  • Primary PCI to occur within 8h from the onset of symptoms
  • Women of childbearing potential must have a negative pregnancy test

Exclusion Criteria:

  • Contraindications to MRI scanning
  • History or ECG evidence of previous STEMI
  • Cardiogenic shock
  • NYHA class III-IV heart failure
  • LBBB or AF on ECG; 6.Major trauma, major surgery, eye, spinal cord, or brain surgery within the last 3 months
  • Significant hepatic disturbance
  • Chronic renal impairment (Creatinine >200µmol/L)
  • Stroke or TIA <6 months
  • Pregnancy or breast-feeding
  • Dependence on alcohol or other DOA
  • Significant psychiatric/neurologic disease that would prevent adherence to the requirements of the protocol
  • Significant immunocompromise (including, but not limited to AIDS and immune-suppressive therapy
  • Current treatment with human recombinant erythropoietin
  • Current hemodialysis or peritoneal dialysis
  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: NCT00149058

Contacts
Contact: Richard G Bogle, MRCP PhD +44(0)20 8383 4829 r.bogle@imperial.ac.uk

Locations
United Kingdom
King's College London Not yet recruiting
London, United Kingdom, W12 0HS
Contact: Narbeh Melikian, MRCP       narbeh.melikian@kcl.ac.uk   
Hammersmith Hospital NHS Trust Not yet recruiting
London, United Kingdom, W12 0HS
Contact: Richard G Bogle, MD MRCP    +44(0)2083834829    r.bogle@imperial.ac.uk   
Sponsors and Collaborators
Hammersmith Hospitals NHS Trust
Investigators
Principal Investigator: Jaspal S Kooner Hammersmith Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00149058     History of Changes
Other Study ID Numbers: 05/MREC00/7
Study First Received: September 6, 2005
Last Updated: September 6, 2005
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Hammersmith Hospitals NHS Trust:
acute myocardial infarction
primary angioplasty

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

ClinicalTrials.gov processed this record on August 20, 2014