To investigate whether the inhalation of helium during rpimary PCI can reduces the size of myocardial infarction.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Infarct size as percentage of the area at risk, determined by MRI 2-4 days
after PCI.
Secondary outcome
MRI on day 2-4: infarct size, area-at-risk (=edema), left ventricular volumes
(LVEDV, LVESV) and ejection fraction
MRI after 4 months: infarct size, left ventricular volumes (LVEDV, LVESV) and
ejection fraction
Troponin: at baseline, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36
hours, 42 hours and 48 hours
NT-proBNP at baseline, 6 hours, 12 hours, 24 hours, 48 hours, 4 days and 4
months
MACE rate during 4 month follow-up
NYHA class at 30 days and 4 months
Background summary
Even when treated with a primairy PCI, patients suffering from a myocardial
infarction can sustain myocardial damage and loss of tissue, which has a
negative effect on the outcome. In animal models of myocardial infarction,
ionhalation of helium has a protective effect and can reduce the amount of lost
tissue. If this is the case in patients as well, helium inhalation can improve
the outcome of patients following myocardial infarction.
Study objective
To investigate whether the inhalation of helium during rpimary PCI can reduces
the size of myocardial infarction.
Study design
Single center, randomised and placebo-controlled, investigator-blinded.
Intervention
Inhalation of helium during the PCI untill 10 minutes after opening of the
target vessel.
Study burden and risks
The risk associated with this study is limited; helium inhalation has no known
side-effects and the MRI scans are safe unless contra-indicated (and those
patients will be excluded). However, extra venapunctions (11 in total), 2x 30
minutes of scanning, a mailed questionaire and 1 out-patient-visit (for the
second scan), will be a minor inconvenience the the participants.
Postbus 22660
1100 DD Amsterdam
NL
Postbus 22660
1100 DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Age 18-75 years
STEMI, treatment with primary PCI
Chest pain duration less than 12 hours
Exclusion criteria
Left bundle-branch block
Trombolytic therapy in the last 30 days
Prio infarction
Prior CABG
Left main stenosis, requiring CABG
Mechanical ventilation
High catecholamines usages
IABP or Impella
Glibenclamide usage
Kidney failure
Contraindication for MRI
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 | EUCTR2010-022393-13-NL |
| CCMO | NL33604.018.10 |