Acute and chronic administration of the folate derivate levofolinate to patients with acute myocardial infarction: A double-blinded placebo-controlled pilot study. Folate in Acute Myocardial Infarction (FolAMI-study)

Phase 3

Conditions: acute myocard infaction
heart infartion
10028593

Registration Number: NL-OMON33443

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 71

Inclusion Criteria

typical retrosternal pain with electocardiographic evidence for ST-elevated myocardial infarction (STEMI)
· Time onset angina pectoris - emergency room:<4h
· Age between 35-75 y
· Coronarographic proof of occluded/critical LAD-lesion
· Successful reperfusion (TIMI >= 2) after dilation and stent placing of culprit LAD-lesion

Exclusion Criteria

· Patients with pernicious anemia or other megaloblastic anemia*s where vitamin B12 is deficient.
· Patients using phenobarbitone, phenytoin and primidone
· Phenylketonuria
· Exogenous administration of FA or multivitamin pills with FA >= 400µg
· Oncologic medical history with methotrexate administration
· Coronary ischemia from other reasons than atheromatose (eg. low-output syndrome, anaemia, drug-abusus)
· Hemodynamic Unstable patients (need for inotropica, IABP)
· Bradycardia (heart rate <40 beats/min).
· 3-vessel disease with prospection of CABG in the following 4m
· Medical history of immunosupression or seizures
· Reduced prognosis due to pre-existing comorbidity
· HCG-positivity or pregnancy-wish
· Administration of thrombolytica (full dose and/or bolus)
· Kidney Failure (GFR<20ml/min)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p> Main study parameter/endpoint<br /><br>The primary endpoints of this double-blinded, placebo-controlled randomized<br /><br>Intervention Study with a monocentric location will improvement of endothelial<br /><br>and myocardial function. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters/endpoints<br /><br>Infarct size, CK-MB and troponine releases, TIMI-bloodflow, ST-segment<br /><br>resolution and the incidence of reperfusion-induced arrhythmia will be<br /><br>investigated as secondary endpoints.</p><br>