A controlled trial to investigate whether by reducing eNOS uncoupling, by direct super oxide scavenging and by up regulating the high-energy phosphate pool, a high dose of intravenous levofolinate can reduce ischemia- and reperfusion-induced…
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
LevoFolinate can become an attractive therapeutic target to reduce
eNOS-dependent ROS generation e.g. during ischemia- and reperfusion-induced
myocardial damage in patients with an acute myocardial infarction.
Study objective
A controlled trial to investigate whether by reducing eNOS uncoupling, by
direct super oxide scavenging and by up regulating the high-energy phosphate
pool, a high dose of intravenous levofolinate can reduce ischemia- and
reperfusion-induced myocardial damage (cell-death, endothelial dysfunction,
myocardial function and arrhythmia).
Study design
A double-blinded placebo-controlled pilot study of acute and chronic
administration of levofolinate (folinic acid) to patients with an acute
myocardial infarction.
Intervention
one time IV foliumzuur, than once daily oral, one capsule.
Study burden and risks
Not applicable
p.debyelaan 25
6202 AZ Maastricht
NL
p.debyelaan 25
6202 AZ Maastricht
NL
Listed location countries
Age
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)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-012526-36-NL |
| CCMO | NL28052.068.09 |