Coronary Thromboaspiration and Infarct Size

Acute Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00456066
• Other study ID #: CHU63-0018
• Status: Terminated
• Phase: N/A
• First received: April 3, 2007
• Last updated: October 7, 2008
• Start date: June 2006
• Est. completion date: December 2007

Study information

• Verified date: October 2008
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Coronary Artery Disease
• Infarction
• Ischemic Heart Disease
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Device:
• Export Aspiration System
Patients scheduled for emergency angioplasty

Locations

Country	Name	City	State
France	Departement of Cardiology and Radiology, University Hospital, and Departement of Nuclear Medicine, Jean Perrin Cancer Centre	Clermont-Ferrand	Auvergne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infarct size and severity assessed by ce-MRI and rest Tc99m-mibi gated SPECT		by ce-MRI and rest Tc99m-mibi gated SPECT	Yes
Secondary	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)	Yes