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OpenTrials
Completed

NCT Number: NCT00288665

Thrombectomy and Improvement of Left Ventricular Function in AMI

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St Antonius Hospital

Nieuwegein, 3435CM, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Export catheter (Medtronic)

Device

Primary outcomes

  1. MRI assessment of LV volumes during hospitalisation and after 3 months

Secondary outcomes

  1. ST-resolution after PCI, serial cardiac enzymes, myocardial blush grade, TIMI flow rate

Sponsors and collaborators

Lead sponsor

R&D Cardiologie

Other

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2005
First posted
Feb 8, 2006
Registry last updated
Feb 8, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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