NCT00456066

Brief Summary

Distal embolization can occur during coronary angioplasty performed in the acute phase of myocardial infarction and is associated with poor long-term outcome. We hypothesize that the use of a system allowing thrombus aspiration before angioplasty and stent implantation will limit infarct size and its severity.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 4, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

October 8, 2008

Status Verified

October 1, 2008

Enrollment Period

1.5 years

First QC Date

April 3, 2007

Last Update Submit

October 7, 2008

Conditions

Ischemic Heart DiseaseAcute Myocardial Infarction

Keywords

Acute myocardial infarctionThromboaspirationInfarct sizeLeft ventricular remodelling

Outcome Measures

Primary Outcomes (1)

  • Infarct size and severity assessed by ce-MRI and rest Tc99m-mibi gated SPECT

    by ce-MRI and rest Tc99m-mibi gated SPECT

Secondary Outcomes (1)

  • Probability of evolution toward left ventricular remodelling (defined as an increase of end-diastolic volume of>20% between the acute phase and 6-montcontrol)

    of end-diastolic volumeof>20% between the acute phase and 6-montcontrol)

Interventions

Export Aspiration SystemDEVICE

Patients scheduled for emergency angioplasty

Eligibility Criteria

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

You may qualify if:

  • acute phase of myocardial infarction (\>48 hours from the onset of chest pain)
  • stable hemodynamic conditions
  • completely occluded infarct related artery

You may not qualify if:

  • heart failure signs in the acute phase
  • contra indication for MRI or SPECT IMAGING

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement of Cardiology and Radiology, University Hospital, and Departement of Nuclear Medicine, Jean Perrin Cancer Centre

Clermont-Ferrand, Auvergne, 63000, France

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Janusz Lipiecki, Pr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2007

First Posted

April 4, 2007

Study Start

June 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

October 8, 2008

Record last verified: 2008-10

Locations

FR(1)