Erythropoietin in Acute Myocardial Infarction
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
1 other identifier
interventional
124
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2005
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 8, 2005
CompletedStudy Start
First participant enrolled
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedSeptember 8, 2005
September 1, 2005
September 6, 2005
September 6, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Myocardial infarct size
Secondary Outcomes (2)
Death
Reinfarction
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hammersmith Hospital NHS Trust
London, W12 0HS, United Kingdom
King's College London
London, W12 0HS, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaspal S Kooner
Hammersmith Hospitals NHS Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 8, 2005
Study Start
October 1, 2005
Study Completion
January 1, 2008
Last Updated
September 8, 2005
Record last verified: 2005-09