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)"

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)" - FolAMI-study, Folate in Acute Myocardial Infarction.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33443

Enrollment

Registered

2009-10-09

Start date

2009-06-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute myocard infaction heart infartion

Interventions

one time IV foliumzuur, than once daily oral, one capsule.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: typical retrosternal pain with electocardiographic evidence for ST-elevated myocardial infarction (STEMI) · Time onset angina pectoris - emergency room:= 2) after dilation and stent placing of culprit LAD-lesion

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main study parameter/endpoint The primary endpoints of this double-blinded, placebo-controlled randomized Intervention Study with a monocentric location will improvement of endothelial and myocardial function.	—

Secondary

Measure	Time frame
Secondary study parameters/endpoints Infarct size, CK-MB and troponine releases, TIMI-bloodflow, ST-segment resolution and the incidence of reperfusion-induced arrhythmia will be investigated as secondary endpoints.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)