Acute Myocardial InfarctionPhase 3TAMINCT00675480
Thrombectomy in Acute Myocardial Infarction
A Phase 3 study testing Thrombectomy and Primary angioplasty in people with Acute Myocardial Infarction, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
Trial summary
The purpose of the study is to determine whether thrombus removal with aspiration thrombectomy for acute myocardial infarction reduces the infarct size. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Thrombectomy and Primary angioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 sitePoland
- Study dates
- Nov 2004to Sep 2008
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- First acute myocardial infarction with ST segment elevation within 12 hours from pain onset
- Culprit lesion in left anterior descending or right coronary artery.
- Coronary flow assessed in TIMI scale ≤ 2
- Presence of total coronary occlusion or angiographically visible thrombus in the culprit vessel
- Patient signed informed consent
Who cannot join
- Cardiogenic shock.
- Culprit lesion in left circumflex coronary artery.
- Status post coronary artery by-pass grafting
- Previous myocardial infarction
- Status post percutaneous coronary intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aspiration Thrombectomy as an Adjunctive Therapy to Primary Angioplasty in Patients With ST Segment Elevation Myocardial Infarction
The purpose of the study is to determine whether thrombus removal with aspiration thrombectomy for acute myocardial infarction reduces the infarct size.
Read the detailed description
Acute myocardial infarction is caused by an abrupt occlusion of coronary vessel or severe reduction of coronary flow. It has been shown that the reperfusion therapy significantly improves the clinical outcome. Currently the optimal strategy is the primary angioplasty with stent implantation. The treatment is recommended by AHA/ACC and ESC if can be performed within 90 minutes from the first medical contact. However there is still a certain percentage of procedure failure. To further improve the outcome new techniques and devices are tested . Aspiration thrombectomy may facilitate the reperfusion by reducing thrombus burden. The aim of the study is to assess if adjunctive thrombectomy may improve clinical outcome in patients with an acute ST segment elevation myocardial infarction.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Thrombectomy, Primary angioplasty
- Keywords
- myocardial infarction, thrombectomy, salvage index
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThrombectomyProcedure or surgery
Also called Rescue (Boston Scientific), Diver (Invatec)
Aspiration Thrombectomy prior to stent implantation in patients with ST segment elevation myocardial infarction
Primary angioplastyProcedure or surgery
Also called Bare metal stent implanted during primary angioplasty
Standard primary angioplasty with stent implantation
| Study group | Role | What they receive |
|---|---|---|
| T | Experimental | Patients treated with thrombectomy: T Receives: Procedure: Thrombectomy |
| P | Active comparator | Patients treated with standard PCI with stent implantation Receives: Procedure: Primary angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial salvage index assessed with SPECT MIBI.
Measured: 5-8 days
Secondary outcomes (4)
In hospital mortality
Measured: in hospital, before discharge
ST segment resolution after PCI;
Measured: 90 minutes
CK-MB AUC
Measured: 72 hours
Corrected TIMI frame count
Measured: immediately post PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2008 (estimated)
- Study startNov 2004
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Investigators
- Michal Ciszewski, MD, PhD, Principal investigator, National Institute of Cardiology, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675480
- Sponsor's protocol ID
- 2PO5C00527
- Acronym
- TAMI
- Status last verified
- Jan 2009
- First submitted
- 7 May 2008
- Last updated
- 29 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Ciszewski M, Pregowski J, Teresinska A, Karcz M, Kalinczuk L, Pracon R, Witkowski A, Ruzyllo W. Aspiration coronary thrombectomy for acute myocardial infarction increases myocardial salvage: single center randomized study. Catheter Cardiovasc Interv. 2011 Oct 1;78(4):523-31. doi: 10.1002/ccd.22933. Epub 2011 Jun 6.
PubMed 21234920
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspiration Thrombectomy as an Adjunctive Therapy to Primary Angioplasty in Patients With ST Segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00675480
- Acronym / sponsor ID
- TAMI / 2PO5C00527
- Conditions
- Acute Myocardial Infarction
- Keywords
- myocardial infarction, thrombectomy, salvage index
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 9 May 2008 (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.
The purpose of the study is to determine whether thrombus removal with aspiration thrombectomy for acute myocardial infarction reduces the infarct size.
Detailed description
Acute myocardial infarction is caused by an abrupt occlusion of coronary vessel or severe reduction of coronary flow. It has been shown that the reperfusion therapy significantly improves the clinical outcome. Currently the optimal strategy is the primary angioplasty with stent implantation. The treatment is recommended by AHA/ACC and ESC if can be performed within 90 minutes from the first medical contact. However there is still a certain percentage of procedure failure. To further improve the outcome new techniques and devices are tested . Aspiration thrombectomy may facilitate the reperfusion by reducing thrombus burden. The aim of the study is to assess if adjunctive thrombectomy may improve clinical outcome in patients with an acute ST segment elevation myocardial infarction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T | Experimental | Procedure: ThrombectomyPatients treated with thrombectomy: T |
| P | Active comparator | Procedure: Primary angioplastyPatients treated with standard PCI with stent implantation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- First acute myocardial infarction with ST segment elevation within 12 hours from pain onset
- Culprit lesion in left anterior descending or right coronary artery.
- Coronary flow assessed in TIMI scale ≤ 2
- Presence of total coronary occlusion or angiographically visible thrombus in the culprit vessel
- Patient signed informed consent
Key exclusion criteria (5 listed)
- Cardiogenic shock.
- Culprit lesion in left circumflex coronary artery.
- Status post coronary artery by-pass grafting
- Previous myocardial infarction
- Status post percutaneous coronary intervention.
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 |
|---|---|---|
| ThrombectomyAlso: Rescue (Boston Scientific), Diver (Invatec)Aspiration Thrombectomy prior to stent implantation in patients with ST segment elevation myocardial infarction | Procedure or surgery | T |
| Primary angioplastyAlso: Bare metal stent implanted during primary angioplastyStandard primary angioplasty with stent implantation | Procedure or surgery | P |
Primary outcome
Myocardial salvage index assessed with SPECT MIBI.
Time frame: 5-8 days
4 secondary outcomes
In hospital mortality
Time frame: in hospital, before discharge
ST segment resolution after PCI;
Time frame: 90 minutes
CK-MB AUC
Time frame: 72 hours
Corrected TIMI frame count
Time frame: immediately post PCI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2009.
- Derived from this study: PubMed 21234920Ciszewski M, Pregowski J, Teresinska A, Karcz M, Kalinczuk L, Pracon R, Witkowski A, Ruzyllo W. Aspiration coronary thrombectomy for acute myocardial infarction increases myocardial salvage: single center randomized study. Catheter Cardiovasc Interv. 2011 Oct 1;78(4):523-31. doi: 10.1002/ccd.22933. Epub 2011 Jun 6.
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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.
Michal Ciszewski, MD, PhD principal investigator
National Institute of Cardiology, Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Thrombectomy and Primary angioplasty in people with Acute Myocardial Infarction, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 29 Jan 2009. 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 Poland. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Myocardial salvage index assessed with SPECT MIBI. (time frame: 5-8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00675480, which also lists 1 linked publication.
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 29 Jan 2009.