No registrations found.
ID
Source
Brief title
Health condition
Acute Myocardial Infarction
Sponsors and support
Intervention
Outcome measures
Primary outcome
30-day major cardiac and cerebral events (MACCE), including peri-procedural complications
Secondary outcome
Pre- and post-reperfusion coronary wedge pressure (CWP) and its association with IS and MVO as measured with cMR
Pre- and post-reperfusion coronary wedge pressure (CWP) and its association with left ventricular ejection fraction and volumes as measured with (2D and 3D) echocardiography
Post-reperfusion index of microvascular resistance (iMR) and its association with cMR indices, electrocardiography (i.e. ST-segment recovery), and echocardiography
Pre- and post-reperfusion CWP and iMR and their association with left ventricular end-diastolic pressure (LVEDP)
Pre- and post-reperfusion CWP and iMR and their association with serum biomarkers (cardiac troponin, lactate)
Post-reperfusion fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) and their association with IS and MVO as measured with cMR
Post-reperfusion FFR and iFR and their association with left ventricular ejection fraction and volumes as measured with (2D and 3D) echocardiography
Post-reperfusion FFR and iFR and their association with cMR indices, electrocardiography (i.e. ST-segment recovery), and echocardiography
Post-reperfusion FFR and iFR and their association with left ventricular end-diastolic pressure (LVEDP)
Post-reperfusion FFR and iFR and their association with serum biomarkers (cardiac troponin, lactate)
Background summary
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.
Study objective
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.
Study design
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
Intervention
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.
Inclusion criteria
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.
Exclusion criteria
Major exclusion criteria are cardiogenic shock and a history of prior myocardial infarction or coronary artery bypass grafting (CABG).
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7379 |
| NTR-old | NTR7587 |
| CCMO | NL68014.029.18 |
| OMON | NL-OMON48480 |