We 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,…
ID
Bron
Verkorte titel
Aandoening
Acute myocardial infarction
acute coronary syndrome
ischemia reperfusion injury
acuut hartinfarct
acuut coronair syndroom
ischemie reperfusie schade
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
On 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.
Achtergrond van het onderzoek
In 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.
Doel van het onderzoek
We 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.
Onderzoeksopzet
Blood 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.
Onderzoeksproduct en/of interventie
Helium inhalation (79%) starting directly after inclusion, untill 10 minutes after opening of the target vessel.
Publiek
Daniel Brevoord
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
d.brevoord@amc.nl
Wetenschappelijk
Daniel Brevoord
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
d.brevoord@amc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age 18-75 years;
2. ST-elevation myocardial infarction;
3. Treatment with primary PCI;
4. Chest pain of <12 hours duration.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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).
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2566 |
| NTR-old | NTR2691 |
| Ander register | METC AMC Amsterdam / CCMO : 10/210 / NL 33604.018.10 ; |