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van CCT (UK)

van CCT (UK)

The use of Helium in acute myocardial infarction trial (HAMI-trial).

- candidate number8929
- NTR NumberNTR2691
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-jan-2011
- Secondary IDs10/210 / NL 33604.018.10 ; METC AMC Amsterdam / CCMO
- Public TitleThe use of Helium in acute myocardial infarction trial (HAMI-trial).
- Scientific TitleDoes helium protect the heart against ischaemia-reperfusion damage in patients with acute myocardial infarction?
- hypothesisWe hypothesize that helium postconditioning reduces ischemia reperfusion injury following an acute myocardial infarction and thereby reduces the size of infarction. Secondly, we hypothesize that this reduction leads to improved myocardial function, less adverse events and less limitations during daily life of the respective patients.
- Healt Condition(s) or Problem(s) studiedAcute myocardial infarction , Acute coronary syndrome (ACS), Ischemia / Reperfusion injury
- Inclusion criteria1. Age 18-75 years;
2. ST-elevation myocardial infarction;
3. Treatment with primary PCI;
4. Chest pain of <12 hours duration.
- Exclusion criteria1. Left bundle branch block;
2. Previous myocardial infarction;
3. Fibrinolytic treatment in the previous 30 days;
4. Previous coronary artery bypass surgery;
5. Left main stenosis requiring coronary bypass surgery;
6. Severe heart failure as witnessed by any of the following:
A. The need for mechanical ventilation;
B. The use of an intra-aortic balloon pump or Impella;
C. High catecholamine usage.
7. Usage of the anti-diabetic drug glibenclamide (this drug is known to block any conditioning effect);
8. Renal failure;
9. Inability to undergo MRI (e.g. due to the presence of pacemaker or ICD).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2011
- planned closingdate31-dec-2013
- Target number of participants70
- InterventionsHelium inhalation (79%) starting directly after inclusion, untill 10 minutes after opening of the target vessel.
- Primary outcomeOn day 4 after the PCI a CMR will be obtained. T-2 weighed imaging shows edema in the tissue which has been ischemic before and is therefore at risk for developing infarction. T-1 weighed imaging after the injection of gadolinium contrast marks the infarcted tissue. Primary endpoint is the total volume of infarction as proportion of the total volume of myocardium at risk.
- Secondary outcomeCMR measurements:
1. On day 2-4: Left ventricular function, left ventricular dimensions, infarct size, edema;
2. After 4 months: Left ventricular function, left ventricular dimensions, infarct size;
3. Biomarker release following the PCI: Troponin T, NT-proBNP;
4. Time of ST-segment resolution after opening of the target vessel;
5. Thrombolysis in myocardial infarction (TIMI);
6. Grade Flow following opening of the target vessel;
7. Occurrence of death, re-infarction and admission for heart failure at 30 days and 4 months following PCI;
8. New York heart Association functional class at 30 days and 4 months following PCI.
- TimepointsBlood samples will be obtained for analysis of troponin T levels at baseline and at 6 hour intervals during the first two days. NT-proBNP levels will be determined at baseline, 6 hours, 12 hours, 24 hours, 48 hours and at 4 days and 4 months after the procedure. Analysis of all the samples will be done in the central laboratory for clinical chemistry at the AMC.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryIn patients with acute myocardial infarction swift revascularistion is the treatment of choice. However, even after PCI tissue dmage continous: ischemia reperfusion injury. In animal models, helium inhalation has been shown to reduce this kind of damage. In this study we investigate whether cotreatment with helium during primairy PCI reduces the size of myocardial infarction in patients.
- Main changes (audit trail)
- RECORD14-jan-2011 - 21-jan-2011

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