NCT00288665

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2006

Completed
Last Updated

February 8, 2006

Status Verified

February 1, 2006

First QC Date

February 6, 2006

Last Update Submit

February 6, 2006

Conditions

Acute Myocardial InfarctionVentricular Remodeling

Keywords

Myocardial infarctionaspirationthrombectomyventricular remodeling

Outcome Measures

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

Interventions

Export catheter (Medtronic)DEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Antonius Hospital

Nieuwegein, 3435CM, Netherlands

Location

MeSH Terms

Conditions

Ventricular RemodelingMyocardial Infarction

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesNecrosis

Study Officials

  • B. Rensing, MD, PhD

    St. Antonius Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 6, 2006

First Posted

February 8, 2006

Study Start

April 1, 2004

Study Completion

December 1, 2005

Last Updated

February 8, 2006

Record last verified: 2006-02

Locations

NL(1)