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

The Feasibility and Safety of Optical Coherence Tomography Guided Thrombus Aspiration in Patients With Initial Conservative Management of Non-ST-Elevation Myocardial Infarction - OCT guided thrombus aspiration

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON36290
Enrollment
30
Registered
2010-05-04
Start date
2010-06-08
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart attack myocardial infarction

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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 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

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 outcomes

Primary

MeasureTime frame
The rate of effective thrombus aspiration as determined by histopathological examination, the residual thrombus load on OCT after thrombus aspiration and stent implantation

Secondary

MeasureTime frame
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).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)