Coronary Thromboaspiration and Infarct Size

Assessment of Efficacity of Coronary Thromboaspiration (Export System) Performed Before Angioplasty on Infarct Size in Patients Treated by Coronary Percutaneous Interventions During Acute Phase.

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00456066

Enrollment

Registered

2007-04-04

Start date

2006-06-30

Completion date

2007-12-31

Last updated

2008-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction, Ischemic Heart Disease

Keywords

Acute myocardial infarction, Thromboaspiration, Infarct size, Left ventricular remodelling

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.

Detailed description

Patients scheduled for emergency angioplasty in the acute phase of a first ST-elevation myocardial infarction will be treated either by thromboaspiration followed by angioplasty or by angioplasty alone. The infarct size and severity will be assessed by ce-MRI and rest Tc99m-mibi gated SPECT performed during initial hospital stay (5th-8th day). A control MRI will be performed at 6-month follow-up to analyse the evolution of left ventricular volumes.

Interventions

DEVICEExport Aspiration System

Patients scheduled for emergency angioplasty

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Infarct size and severity assessed by ce-MRI and rest Tc99m-mibi gated SPECT	by ce-MRI and rest Tc99m-mibi gated SPECT

Secondary

Measure	Time frame
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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026