The objective of the study is to assess the feasibility and diagnostic yield of OCT guided thrombus aspiration in patients presenting with initial conservative management of non-ST-elevation myocardial infarction (NSTEMI).
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The rate of effective thrombus aspiration as determined by histopathological
examination, the residual thrombus load on OCT after thrombus aspiration and
stent implantation
Secondary outcome
Improvement of angiographic parameters (thrombosis in myocardial infarction
flow grade, myocardial blush grade, distal embolization), and
clinical outcomes (death, myocardial infarction, target vessel
revascularization 30 days after the procedure).
Background summary
Embolization of atherothrombotic material is common during percutaneous
coronary intervention (PCI) in patients with acute coronary syndromes (ACS).
This may lead to occlusion of distal vessels resulting in impaired myocardial
perfusion, which is associated with larger infarct size and increased
mortality. Optical coherence tomography (OCT) is a new imaging modality
allowing invasive assessment of coronary artery thrombus load before and after
the PCI.
Study objective
The objective of the study is to assess the feasibility and diagnostic yield of
OCT guided thrombus aspiration in patients presenting with initial conservative
management of non-ST-elevation myocardial infarction (NSTEMI).
Study design
A pilot study.
Study burden and risks
Based on currently available clinical evidence risks related to the devices
used in this study is comparable to standard equipment used for conventional
PCI.
Hanzeplein 1
9700 RB Groningen
NL
Hanzeplein 1
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
- Chest pain suggestive for myocardial ischemia for at least 30 minutes,
- Electrocardiogram (ECG) with ST- segment shifts (ST-segment depression >1 mm in at least two contiguous leads or transient ST-segment elevation >1 mm with duration of <30 min in at least two contiguous leads) and/or T-wave changes (T-wave inversion >1.5 mm in at least three contiguous leads),
- Positive troponin T >0,04 µg/L.
- Time between the onset of last symptoms and PCI of more than 12 hours and shorter than 7 days,
- initial conservative management (e.g. asprin, heparine, statins)
- The presence of one ischemia-related target lesion on invasive coronary angiography with a clinical indication for PCI,
- TIMI flow grade of 2 or higher,
- Vessel suitable for 2.25 mm diameter or larger stent implantation,
- Informed consent.
Exclusion criteria
- Persistent ST-elevation of > 1 mm in 2 or more leads,
- TIMI 0 or 1 flow on coronary angiography,
- Need for emergency coronary artery bypass grafting,
- Presence of cardiogenic shock,
- Preexisting life-threatening disease with a life expectancy of less than 6 months,
- Creatinine > 200 µmol/l before the procedure,
- Inability to provide informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31609.042.10 |