Treatment of ST-elevation myocardial infarction (STEMI) by means of mechanically reperfusion is often accompanied by reperfusion injury. As pre- and postconditioning in STEMI appears to be ineffective, cardioprotection should occur in parallel (…
ID
Bron
Verkorte titel
Aandoening
Acute Myocardial Infarction
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
30-day major cardiac and cerebral events (MACCE), including peri-procedural complications
Achtergrond van het onderzoek
Treatment of ST-elevation myocardial infarction (STEMI) by means of mechanically reperfusion has been shown to be of prognostic relevance. A downside of mechanically reperfusion is that it is often accompanied by reperfusion - or microvascular injury. Recently a promising technique to tackle reperfusion injury has been developed, bloodless reperfusion. In the current trial we will evaluate the safety and feasibility of this technique as well as evaluate intracoronary derived pressure parameters to identify microvascular injury prior to reperfusion in a STEMI population.
Doel van het onderzoek
Treatment of ST-elevation myocardial infarction (STEMI) by means of mechanically reperfusion is often accompanied by reperfusion injury. As pre- and postconditioning in STEMI appears to be ineffective, cardioprotection should occur in parallel (perconditioning) to the sustained coronary occlusion and interact with the distal coronary arterial micro-circulation prior to epicardial restoration of flow. This is known as bloodless reperfusion and constitutes a new therapeutic strategy to tackle reperfusion injury.
Onderzoeksopzet
The technique of bloodless reperfusion and measurement of CWP, IMR, iFR and FFR will be executed during the index procedure, the primairy PCI.
CMR will be performed at 2-7 days and 1 month follow-up
Onderzoeksproduct en/of interventie
The bloodless reperfusion technique will be evuluated:
A adequately sized semi-compliant balloon will be inflated at low pressure (2-4atm) proximal to the occlusion. Thereafter a double lumen microcatheter (over-the-wire) will be advanced distal to the occlusion. Coronary wedge pressure (CWP) will be measured with a pressure wire advanced through the microcatheter. Bloodless reperfusion can also be achieved through the micocatheter.
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients with an acute STEMI are eligible when they meet the following inclusion criteria: Symptom onset < 6 hours, Thrombolysis In Myocardial Infarction (TIMI) 0 flow, and at least 1 intermediate lesion in a non-infarct related artery.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Major exclusion criteria are cardiogenic shock and a history of prior myocardial infarction or coronary artery bypass grafting (CABG).
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL7379 |
NTR-old | NTR7587 |
CCMO | NL68014.029.18 |
OMON | NL-OMON48480 |