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Thrombectomy and Improvement of Left Ventricular Function in AMI

Thrombectomy Before Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction Improves Left Ventricular Function at 3 Months

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00288665
Enrollment
50
Registered
2006-02-08
Start date
2004-04-30
Completion date
2005-12-31
Last updated
2006-02-08

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

Conditions

Acute Myocardial Infarction, Ventricular Remodeling

Keywords

Myocardial infarction, aspiration, thrombectomy, ventricular remodeling

Brief summary

To study the effect of a simple and fast 'modus operandi' by aspiration of thrombus and debris with the Export catheter in an acute occlusion, on microvascular (re)perfusion and late left ventricular remodeling. Subsequently determinating if PCI with primary aspiration as an adjunct is superior to standard PCI. Microvascular (re)perfusion will be assessed with angiographic and electrocardiographic measurements (TIMI frame count, TIMI flow grade, Blush score, ST-T segment measurements). Early and late left ventricular function and infarct size will be measured with serial MRI imaging.

Detailed description

Percutaneous coronary intervention (PCI) has dramatically improved mortality and morbidity in patients suffering an acute ST elevation myocardial infarction. Infarct size reduction, prevention of recurrent infarction and improved wound healing are thought to be the mechanisms responsible for the short and long-term clinical benefit of the procedure. In spite of this, myocardial salvage after PCI is often suboptimal because of distal embolisation of atherothrombotic debris and intense microcirculatory vasoconstriction caused by vasoactive substances released from platelets. This will cause a larger infarcted area with increased early and late left ventricular remodelling. Prevention of debris embolisation is therefore a potentially way to further improve myocardial salvage and thus mortality in patients suffering an acute myocardial infarction. One approach towards embolisation prevention is intracoronary thrombectomy before PCI. Current thrombectomy devices can be classified as fragmentation/suction devices such as the X-sizer catheter and the AngioJet device and the more simple and less costly suction-only devices such as the Export catheter, the Diver CE aspiration catheter (10) and the Rinspiration system. In trials published so far improved outcome has been shown with endpoints representing myocardial perfusion such as ST-T segment resolution, TIMI flow grade, TIMI frame count and myocardial blush grade. These trials were not powered to show differences in clinical end-points. White et al (11) showed that the best predictor of survival after initial recovery from myocardial infarction is left ventricular end-systolic volume index (ESVI). Regional and global left ventricular function and morphology can be quantified with high reproducibility by cine magnetic resonance imaging (MRI)(12). The method is safe, non invasive, well validated and is at the moment the standard of reference for left ventricular function assessment. The high reproducibility of the technique allows the detection of between-group differences in LV volumes with relatively few patients. This makes MRI measured left ventricular end systolic volume index a very attractive surrogate end-point for small hypothesis forming clinical trials. We therefore conducted a randomized trial with MRI assessment of LV volumes to evaluate the effect of intracoronary thrombectomy prior to mechanical reperfusion therapy in AMI on early and late left ventricular remodelling

Interventions

DEVICEExport catheter (Medtronic)

Sponsors

R&D Cardiologie
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

- AMI developed \< 12-hr - Reference lumen diameter (RLD) of infarct related artery (IRA) \> 3.0 mm

Exclusion criteria

- electrical instability- patient is in Killip class 3 or 4 of heart failure- implanted electronic devices are present- all implants held by magnets/fragments/devices

Design outcomes

Primary

MeasureTime frame
MRI assessment of LV volumes during hospitalisation and after 3 months

Secondary

MeasureTime frame
ST-resolution after PCI, serial cardiac enzymes, myocardial blush grade, TIMI flow rate

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026