This study is designed to investigate the limiting effect on infarct size of high dose intravenous adenosine during primary angioplasty
ID
Source
Brief title
Condition
- Coronary artery disorders
- Cardiac therapeutic procedures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Infarct size and no-reflow zone on CE-MRI 3 months after index PCI
Secondary outcome
ST-segment resolution, angiographic parameters, enzymatic infarctsize,
ventricular function, clinical parameters
Background summary
Patients with acute myocardial infarction are best treated with recanalization
of the occluded coronary artery by primary angioplasty. Of these patients,
25-30% has signs of incomplete or absent microvascular coronary reflow. The
exact cause is unknown but it is complicated by a high morbidity and mortality
rate. Adenosine has shown to ameliorate coronary flow. Studies to limit infarct
size with adenosine are equivocal, but are mainly performed with low dose.
Study objective
This study is designed to investigate the limiting effect on infarct size of
high dose intravenous adenosine during primary angioplasty
Study design
Randomized study comparing standard care to standard care plus intravenous
adenosine during primary PCI in patient with acute myocardial infarction.
Intervention
Intravenous Adenosine 140 µg/kg per min during the course of the PCI (appr. 1
hour)
Study burden and risks
Side effects of Adenosine: atrioventricular block and brochospasm: small risk
and terminated quickly due to short half-lifetime of adenosine: less than 10
seconds.
Side effects of MRI contrast agent (Gadolinium): allergic reaction: small risk
and well treated with antihistaminica and corticosteroids.
Haaksbergerstraat 55
7513 ER
NL
Haaksbergerstraat 55
7513 ER
NL
Listed location countries
Age
Inclusion criteria
Patients with acute myocardial infarction with clinical indication for primary PCI.
Symptoms of myocardial ischemia less then 6 hours (12 hours in case of anterior infarction with persistent complaints).
Exclusion criteria
history of myocardial infarction
history of heart surgery
obstructive lungdisease
second degree AV-block.
pregnant women
contra-indication for MRI
impossibility to give informed consent
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 | EUCTR2007-003611-31-NL |
| CCMO | NL19151.044.07 |