Ischemic Heart DiseaseNCT00456066
Coronary Thromboaspiration and Infarct Size
A study testing Export Aspiration System in people with Ischemic Heart Disease and Acute Myocardial Infarction, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ischemic Heart Disease, Acute Myocardial Infarction
- What is being tested?
- Export Aspiration System
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2006to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- acute phase of myocardial infarction (>48 hours from the onset of chest pain)
- stable hemodynamic conditions
- completely occluded infarct related artery
Who cannot join
- heart failure signs in the acute phase
- contra indication for MRI or SPECT IMAGING
Trial locations and contacts
1 site in 1 country.
France1 site
Departement of Cardiology and Radiology, University Hospital, and Departement of Nuclear Medicine, Jean Perrin Cancer Centre
Clermont-Ferrand, Auvergne, 63000
About this study
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.
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.
Read the 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.
- Being tested
- Export Aspiration System
- Keywords
- Acute myocardial infarction, Thromboaspiration, Infarct size, Left ventricular remodelling
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Export Aspiration SystemDevice
Patients scheduled for emergency angioplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct size and severity assessed by ce-MRI and rest Tc99m-mibi gated SPECT
Measured: 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)
Measured: of end-diastolic volumeof>20% between the acute phase and 6-montcontrol)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2007 (estimated)
- Study startJun 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Investigators
- Janusz Lipiecki, Pr, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456066
- Sponsor's protocol ID
- CHU63-0018
- Status last verified
- Oct 2008
- First submitted
- 3 Apr 2007
- Last updated
- 8 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00456066
- Acronym / sponsor ID
- CHU63-0018
- Keywords
- Acute myocardial infarction, Thromboaspiration, Infarct size, Left ventricular remodelling
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 4 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- acute phase of myocardial infarction (>48 hours from the onset of chest pain)
- stable hemodynamic conditions
- completely occluded infarct related artery
Key exclusion criteria (2 listed)
- heart failure signs in the acute phase
- contra indication for MRI or SPECT IMAGING
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Export Aspiration SystemPatients scheduled for emergency angioplasty | Device | – |
Primary outcome
Infarct size and severity assessed by ce-MRI and rest Tc99m-mibi gated SPECT
Time frame: by ce-MRI and rest Tc99m-mibi gated SPECT
1 secondary outcome
Probability of evolution toward left ventricular remodelling (defined as an increase of end-diastolic volume of>20% between the acute phase and 6-montcontrol)
Time frame: of end-diastolic volumeof>20% between the acute phase and 6-montcontrol)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janusz Lipiecki, Pr principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Export Aspiration System in people with Ischemic Heart Disease and Acute Myocardial Infarction, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infarct size and severity assessed by ce-MRI and rest Tc99m-mibi gated SPECT (time frame: by ce-MRI and rest Tc99m-mibi gated SPECT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2008.