Primary objective is to assess the safety, feasibility and efficacy of the bloodless reperfusion technique in patients with STEMI. Secondly, we will collect pre- and post-reperfusion indices of microvascular (dys)function which may act as efficacy…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
30-day major cardiac and cerebral events (MACCE), including peri-procedural
complications
Time from start bloodless reperfusion technique (i.e. proximal balloon
inflation) to PCI
Coronary wedge pressure (CWP) before saline infusion compared with CWP directly
after saline infusion (prior to the actual opening of the infarct related
artery), representing acute cardioprotection
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)
* 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)
Background summary
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 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 objective
Primary objective is to assess the safety, feasibility and efficacy of the
bloodless reperfusion technique in patients with STEMI. Secondly, we will
collect pre- and post-reperfusion indices of microvascular (dys)function which
may act as efficacy markers in future trials.
Study design
We will conduct a prospective, single-center registry in which the safety,
feasibility and efficacy of the bloodless reperfusion technique will be
studied. Furthermore, intracoronary measurements in the acute setting are
collected and linked to infarct size (IS) and microvascular obstruction (MVO)
as obtained by cardiac magnetic resonance (cMR).
Study burden and risks
Patients are subjected to state-of-the-art cardiac (interventional) care in
concordance with international guidelines as applied to all STEMI patients.
Additionally, Doppler flow / thermodilution measurements will be conducted
during primary PCI (pPCI). All materials and devices are routinely available at
our catheterisation laboratory and are of low burden to the patients. Except
from the bloodless reperfusion technique, all invasive methods and measurements
are part of daily clinical care.
CMR is considered standard of post-STEMI care to evaluate the impact of the
myocardial infarction on left ventricular function.
Boelelaan 1117
Amsterdam 1081HV
NL
Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
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. Patients need to be hemodynamically stable, responsive and
compos mentis.
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
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL68014.029.18 |
| OMON | NL-OMON20782 |