The Feasibility and Safety of Optical Coherence Tomography Guided Thrombus Aspiration in Patients With Initial Conservative Management of Non-ST-Elevation Myocardial Infarctio

Completed

Conditions: heart attack
myocardial infarction
10011082

Registration Number: NL-OMON36290

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The rate of effective thrombus aspiration as determined by histopathological<br /><br>examination, the residual thrombus load on OCT after thrombus aspiration and<br /><br>stent implantation </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Improvement of angiographic parameters (thrombosis in myocardial infarction<br /><br>flow grade, myocardial blush grade, distal embolization), and<br /><br>clinical outcomes (death, myocardial infarction, target vessel<br /><br>revascularization 30 days after the procedure).</p><br>