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Thrombectomy and Improvement of Left Ventricular Function in AMI

Primary Purpose

Acute Myocardial Infarction, Ventricular Remodeling

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Export catheter (Medtronic)
Sponsored by
R&D Cardiologie
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Myocardial infarction, aspiration, thrombectomy, ventricular remodeling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St Antonius Hospital

Outcomes

Primary Outcome Measures

MRI assessment of LV volumes during hospitalisation and after 3 months

Secondary Outcome Measures

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

Full Information

First Posted
February 6, 2006
Last Updated
February 6, 2006
Sponsor
R&D Cardiologie
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1. Study Identification

Unique Protocol Identification Number
NCT00288665
Brief Title
Thrombectomy and Improvement of Left Ventricular Function in AMI
Official Title
Thrombectomy Before Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction Improves Left Ventricular Function at 3 Months
Study Type
Interventional

2. Study Status

Record Verification Date
February 2006
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
R&D Cardiologie

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction, Ventricular Remodeling
Keywords
Myocardial infarction, aspiration, thrombectomy, ventricular remodeling

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Export catheter (Medtronic)
Primary Outcome Measure Information:
Title
MRI assessment of LV volumes during hospitalisation and after 3 months
Secondary Outcome Measure Information:
Title
ST-resolution after PCI, serial cardiac enzymes, myocardial blush grade, TIMI flow rate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
B. Rensing, MD, PhD
Organizational Affiliation
St. Antonius Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
St Antonius Hospital
City
Nieuwegein
ZIP/Postal Code
3435CM
Country
Netherlands

12. IPD Sharing Statement

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Thrombectomy and Improvement of Left Ventricular Function in AMI

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