Clinical Study to Examine the Effects of Erythropoietin on Left

Status Completed

Clinical Trial Summary

The primary objective of this study is to establish the effects of a single bolus of EPO, administered within three hours after a primary PCI for a first acute myocardial infarction, on left ventricular function.

Clinical Trial Description

Erythropoetin (EPO) is commonly known as an effective treatment for anemia. However, several important extra-hematopoeitic effects of EPO are suggested which might be beneficial in the setting of an acute myocardial infarction, such as a reduction of apoptosis and stimulation of neovascularisation. Recent animal studies provided very consistent evidence for a reduced infarct size and improved left ventricular function caused by EPO administration. However, clinical studies with EPO in non-anemic patients are scarce.

We performed a safety study in our department on the effects of a single bolus of EPO in patients with an acute myocardial infarction. Serum EPO levels increased a 200-fold and EPO administration was not associated with hypertension, nor with an increase in thrombocytes or thrombotic events.

In conclusion, experimental data clearly showed that a single bolus of EPO after the onset of an acute myocardial infarction reduced myocardial infarct size, and improved left ventricular function. In our safety study, EPO administration in patients with an acute myocardial infarction was safe and well tolerated.

This will be a PROBE (Prospective, Randomised, Open label study with Blinded Endpoint) designed study, in wich one group will receive one bolus of EPO 60.000 IU) intravenously within 3 hours after the primary PCI procedure and the other group will receive standard therapy. After 6 weeks left ventricular ejection fraction will be evaluated by planar radionuclide ventriculography. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00449488
Study type	Interventional
Source	University Medical Center Groningen
Contact
Status	Completed
Phase	Phase 2
Start date	January 2007
Completion date	October 2009

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06013813` - Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI	N/A
Completed	`NCT04507529` - Peer-mentor Support for Older Vulnerable Myocardial Infarction Patients	N/A
Recruiting	`NCT06066970` - Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery
Recruiting	`NCT03620266` - Effects of Bilberry and Oat Intake After Type 2 Diabetes and/or MI	N/A
Completed	`NCT04097912` - Study to Gather Information to What Extent Patients Follow the Treatment Regimen of Low-dose Aspirin for Primary and Secondary Prevention of Diseases of the Heart and Blood Vessels
Completed	`NCT04153006` - Comparison of Fingerstick Versus Venous Sample for Troponin I.
Completed	`NCT03668587` - Feasibility and Security of a Rapid Rule-out and rule-in Troponin Protocol in the Management of NSTEMI in an Emergency Departement
Recruiting	`NCT01218776` - International Survey of Acute Coronary Syndromes in Transitional Countries
Completed	`NCT03076801` - Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease?	N/A
Recruiting	`NCT05371470` - Voice Analysis Technology to Detect and Manage Depression and Anxiety in Cardiac Rehabilitation	N/A
Recruiting	`NCT04562272` - Attenuation of Post-infarct LV Remodeling by Mechanical Unloading Using Impella-CP	N/A
Completed	`NCT04584645` - A Digital Flu Intervention for People With Cardiovascular Conditions	N/A
Active, not recruiting	`NCT04475380` - Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
Not yet recruiting	`NCT06007950` - Time-restricted Eating Study (TRES): Impacts on Anthropometric, Cardiometabolic and Cardiovascular Health	N/A
Withdrawn	`NCT05327855` - Efficacy and Safety of OPL-0301 Compared to Placebo in Adults With Post-Myocardial Infarction (MI)	Phase 2
Recruiting	`NCT02876952` - High Intensity Aerobic Interval Training With Mediterranean Diet Recommendations in Post-Myocardial Infarct Patients	N/A
Completed	`NCT02917213` - Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
Completed	`NCT02711631` - Feasibility and Effectiveness of Remote Virtual Reality-Based Cardiac Rehabilitation	N/A
Completed	`NCT02382731` - Interventions to Support Long-Term Adherence aNd Decrease Cardiovascular Events Post-Myocardial Infarction	N/A
Completed	`NCT02305602` - A Study of VentriGel in Post-MI Patients	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Study to Examine the Effects of Erythropoietin on Left Ventricular Function After Acute Myocardial Infarction — HEBEIII

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms