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Thrombectomy and Improvement of Left Ventricular Function in AMI

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ClinicalTrials.gov Identifier: NCT00288665
Recruitment Status : Completed
First Posted : February 8, 2006
Last Update Posted : February 8, 2006
Information provided by:
R&D Cardiologie

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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Ventricular Remodeling Device: Export catheter (Medtronic) Phase 4

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Thrombectomy Before Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction Improves Left Ventricular Function at 3 Months
Study Start Date : April 2004
Estimated Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Primary Outcome Measures :
  1. MRI assessment of LV volumes during hospitalisation and after 3 months

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00288665

St Antonius Hospital
Nieuwegein, Netherlands, 3435CM
Sponsors and Collaborators
R&D Cardiologie
Study Chair: B. Rensing, MD, PhD St. Antonius Hospital

ClinicalTrials.gov Identifier: NCT00288665     History of Changes
Other Study ID Numbers: Versie 1.0 d.d. 1-7-2004
First Posted: February 8, 2006    Key Record Dates
Last Update Posted: February 8, 2006
Last Verified: February 2006

Keywords provided by R&D Cardiologie:
Myocardial infarction
ventricular remodeling

Additional relevant MeSH terms:
Myocardial Infarction
Ventricular Remodeling
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pathological Conditions, Anatomical