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High dose adenosine in acute myocardial infarction study


- candidate number3787
- NTR NumberNTR1394
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-aug-2008
- Secondary IDsP07-37 
- Public TitleHigh dose adenosine in acute myocardial infarction study
- Scientific TitleHigh dose adenosine in acute myocardial infarction study
- ACRONYMHAMMER 2
- hypothesisAdenosine infusion during primary PCI for acute myocardial infarction can reduce the area of no reflow and final necrosis.
- Healt Condition(s) or Problem(s) studiedMyocardial infarction, Percutaneous Coronary Intervention (PCI), Myocardial infarction , Adenosine
- Inclusion criteria1. Acute myocardial infarction (typical chest pain for at least 30 minutes and less then 12 hours, and > 1 mm ST-segment elevation in > 2 leads) for which primary PCI is performed.
- Exclusion criteria1. Haemodynamic instability
2. Severe COPD
3. Second degree atrioventriculair block
4. Persistent atrial fibrillation
5. History of myocardial infarction
6. (sub)acute stent trombosis
7. No informed consent
8. Pregnancy
9. Claustrofobia, intracerebral clips
10. Previous heart surgery or pacemaker
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2008
- planned closingdate1-sep-2010
- Target number of participants80
- InterventionsThe treatment group of 40 patients will receive intravenous adenosine 140 mug/kg per minute, during the PCI, starting before reperfusion.
Non-treatment group (40 patients) will recieve care as usual.
- Primary outcomeArea of 'no reflow' and final infarct area determined by 3 month MRI
- Secondary outcomeLeft Ventricle function, ST-segment resolution, enzyme release, angiographic parameters (MBG, TFC), clinical end points
- Timepoints3 months and 1 year
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES M.G. Stoel
- CONTACT for SCIENTIFIC QUERIES M.G. Stoel
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
Stichting Hartcentrum Twente
- PublicationsStoel MG, Marques KM, de Cock CC, Bronzwaer JG, von Birgelen C, Zijlstra F.

High dose adenosine for suboptimal myocardial reperfusion after primary PCI: A randomized placebo-controlled pilot study. Catheter Cardiovasc Interv. 2008 Feb 15;71(3):283-9.
- Brief summaryPatients 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 unequivocal, but are mainly performed with low dose. The randomized and placebo controlled HAMMER 1 study shows benefit of high dose adenosine in patients with suboptimal coronary reflow, ameliorating ST-segment resolution and limiting enzymatic infarct size. To further investigate its potential, this randomized study is designed to quantitate the positive effect of high dose intravenous adenosine during primary angioplasty, measuring infarct size and no reflow zone with contrast enhanced MRI.
- Main changes (audit trail)
- RECORD4-aug-2008 - 13-aug-2008


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