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Hemoglobin Kinetics in Response to Mircera® in Patients With Acute Myocardial Infarction

2014-08-27 03:14:58 | BioPortfolio

Summary

Hypothesis:

Based on available pharmacokinetic data from healthy volunteers we hypothesize that the administration of a cumulative dose of 210μg of the continuous erythropoietin receptor activator, Mircera® (Roche), during 3 months post percutaneous coronary intervention (PCI) does not result in hemoglobin (Hb) levels >15 g/dl in patients with ST-segment elevation myocardial infarction (STEMI)

Design:

Prospective, open label single center pilot study

Description

This pilot trial will include 8 patients. The inclusion of 8 patients will allow to perform representative statistics of expected Hb kinetics in response to Mircera®.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Acute Myocardial Infarction

Intervention

methoxy-polyethylenglycolum epoetinum beta

Location

University Hospital Basel
Basel
Switzerland
4031

Status

Recruiting

Source

University Hospital, Basel, Switzerland

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:58-0400

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Medical and Biotech [MESH] Definitions

MYOCARDIAL INFARCTION in which the anterior wall of the heart is involved. Anterior wall myocardial infarction is often caused by occlusion of the left anterior descending coronary artery. It can be categorized as anteroseptal or anterolateral wall myocardial infarction.

A myocardial infarction that does not produce elevations in the ST segments of the ELECTROCARDIOGRAM. ST segment elevation of the ECG is often used in determining the treatment protocol (see also ST Elevation Myocardial Infarction).

A clinical syndrome defined by MYOCARDIAL ISCHEMIA symptoms; persistent elevation in the ST segments of the ELECTROCARDIOGRAM; and release of BIOMARKERS of myocardial NECROSIS (e.g., elevated TROPONIN levels). ST segment elevation in the ECG is often used in determining the treatment protocol (see also NON-ST ELEVATION MYOCARDIAL INFARCTION).

An episode of MYOCARDIAL ISCHEMIA that generally lasts longer than a transient anginal episode but that does not usually result in MYOCARDIAL INFARCTION.

MYOCARDIAL INFARCTION in which the inferior wall of the heart is involved. It is often caused by occlusion of the right coronary artery.

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