Coronary Thromboaspiration and Infarct Size | NCT00456066

Studies
Coronary Thromboaspiration and Infarct Size

NCT00456066

Sponsor

University Hospital, Clermont-Ferrand

Status

Terminated

Last Update Posted

Oct 8, 2008Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Ischemic Heart Disease
Acute Myocardial Infarction

Interventions

Export Aspiration System

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Apr 3, 2007

First Submission Date that Met QC Criteria

Apr 3, 2007

First Posted Date

Apr 4, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2008

Last Update Posted Date

Oct 8, 2008Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Export Aspiration System	Device	Patients scheduled for emergency angioplasty

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Janusz Lipiecki, Pr		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Departement of Cardiology and Radiology, University Hospital, and Departement of Nuclear Medicine, Jean Perrin Cancer Centre		Clermont-Ferrand	Auvergne	63000	France

Condition Browse Module

MeSH Terms

ID	Term
D017202	Myocardial Ischemia

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided