Thrombectomy and Improvement of Left Ventricular Function in AMI

This study has been completed.
Sponsor:
Information provided by:
R&D Cardiologie
ClinicalTrials.gov Identifier:
NCT00288665
First received: February 6, 2006
Last updated: NA
Last verified: February 2006
History: No changes posted
  Purpose

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 Intervention Phase
Acute Myocardial Infarction
Ventricular Remodeling
Device: Export catheter (Medtronic)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Thrombectomy Before Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction Improves Left Ventricular Function at 3 Months

Resource links provided by NLM:


Further study details as provided by R&D Cardiologie:

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

Estimated Enrollment: 50
Study Start Date: April 2004
Estimated Study Completion Date: December 2005
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00288665

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

No publications provided

ClinicalTrials.gov Identifier: NCT00288665     History of Changes
Other Study ID Numbers: Versie 1.0 d.d. 1-7-2004
Study First Received: February 6, 2006
Last Updated: February 6, 2006
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

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

ClinicalTrials.gov processed this record on April 22, 2014