Myocardial InfarctionPhase 3PATA-STEMINCT01824641
Physiologic Assessment of Thrombus Aspiration in Acute ST-segment Elevation Myocardial Infarction Patients
A Phase 3 study testing Eliminate aspiration catheter and Conventional primary angioplasty in people with Myocardial Infarction, run by Clinical Centre of Serbia at 2 sites in Serbia.
Trial summary
The Physiologic Assessment of Thrombus Aspiration in ST-segment Elevation Myocardial Infarction (PATA-STEMI) trial is a single center, prospective, randomized trial with a planned inclusion of 128 patients with the first ST-segment elevation myocardial infarction (STEMI). Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Eliminate aspiration catheter and Conventional primary angioplasty
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesSerbia
- Study dates
- Sep 2012to Nov 2013
- 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 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All consecutive patients with STEMI
- chest pain onset ≤12h, or >12 h with persistent ST-segment elevation
- hemodynamically stable patients
Who cannot join
- patients without diagnosis of STEMI (pericarditis, for example)
- no written informed consent obtained
- prior Q or non-Q MI
- prior resuscitation
- prior thrombolysis
- prior surgical myocardial revascularisation
- life expectancy <6 months
- periprocedural death
Trial locations and contacts
2 sites in 1 country.
Serbia2 sites, 2 recruiting
- Recruiting
Clinical center of Serbia
Belgrade, 11000
Milorad Tesic, MD, +381113615433, misa.tesic@gmail.com
Miodrag Ostojic, Prof
- Recruiting
Clinical Center of Serbia
Belgrade
Dejan Orlic, +381113615433
Dejan Orlic, MD
About this study
Official title: The Randomized Physiologic Assessment of Thrombus Aspiration in Patients With Acute ST-segment Elevation Myocardial Infarction Trial
The Physiologic Assessment of Thrombus Aspiration in ST-segment Elevation Myocardial Infarction (PATA-STEMI) trial is a single center, prospective, randomized trial with a planned inclusion of 128 patients with the first ST-segment elevation myocardial infarction (STEMI). Patients are, before coronary angiography, randomly assigned to thrombus aspiration using 6 or 7 French Eliminate aspiration catheter (Terumo Medical Supply, Japan) or to conventional primary percutaneous coronary intervention (PCI). The primary endpoint is index of microcirculatory resistance (IMR), measured in infarct-related artery, in thrombus aspiration compared to conventional PCI group.
Read the detailed description
Background and Objective Routine thrombus aspiration is superior to conventional primary PCI in terms of improved myocardial perfusion in STEMI patients. However, myocardial perfusion after thrombus aspiration has not been evaluated by a quantitative, invasive method. Investigators intend to determine whether thrombus aspiration of the infarct-related artery increases myocardial perfusion, as measured by IMR, compared to conventional primary PCI.
Study design PATA-STEMI is a single center, prospective, randomized trial with a planned inclusion of 128 patients with the first STEMI. Patients are randomly assigned, before coronary angiography, to thrombus aspiration using the 6 or 7 French Eliminate aspiration catheter (Terumo Medical Supply, Japan) or to conventional primary PCI. The IMR will be determined in infarct-related artery and non-infarct-related arteries without critical stenosis to measure microcirculatory resistance. The primary endpoint is defined as IMR in infarct-related artery in thrombus aspiration compared to conventional PCI group. Secondary end points are myocardial perfusion grade and resolution of ST-segment elevation, infarct size and left ventricle remodeling, as assessed by echocardiographic indices. Transthoracic echocardiography will be conducted within 24 hours and at 4 months after the primary PCI.
Implications: If manual thrombus aspiration reduces microcirculatory resistance, indicating improved myocardial perfusion, as compared to conventional PCI, it might become the preferred strategy in patients with STEMI.
- Conditions
- Myocardial Infarction
- Being tested
- Eliminate aspiration catheter, Conventional primary angioplasty
- Keywords
- Acute myocardial infarction, Manual thrombus aspiration, Coronary physiology
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eliminate aspiration catheterDevice
Eliminate aspiration catheter
Conventional primary angioplastyProcedure or surgery
Primary angioplasty without thrombus aspiration
| Study group | Role | What they receive |
|---|---|---|
| Eliminate | Experimental | Eliminate aspiration catheter Receives: Device: Eliminate aspiration catheter |
| Conventional primary angioplasty | Active comparator | Patients treated with conventional primary angioplasty Receives: Procedure: Conventional primary angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
IMR (mmHg seconds) in thrombus aspiration compared to conventional PCI group
IMR will be measured after final balloon inflation or stent implantation, an expected average of 45 minutes after sheath insertion
Measured: At the end of the primary PCI , an expected average of 45 minutes after sheath insertion
Secondary outcomes (5)
Resolution of ST-segment elevation
ST-segment resolution ≥70% at 60 minutes after guiding catheter removal
Measured: at 60 minutes after guiding catheter removal
myocardial blush grade (0-3)
myocardial blush grade will be assessed after IMR measurements, following the final balloon inflation or stent implantation, an expected average of 55 minutes after sheath insertion
Measured: at final angiogram, an expected average of 55 minutes after sheath insertion
infarct size assessed by peak enzyme release (Troponin, creatine kinase MB (CK-MB))
infarct size will be determined based on peak enzyme release (Troponin, CK-MB) during in-hospital stay, an expected average of 5 days
Measured: in hospital course after primary PCI, an expected average of 5 days
indices of left ventricle remodeling on Echocardiography
left ventricle remodeling will be assessed on Echocardiography within 24 hours and at 4 months after primary PCI
Measured: within 24 hours and at 4 months after primary PCI
infarct size determined by SPECT
infarct size will be determined by SPECT within 7-14 days and at 4 months after primary PCI
Measured: within 7-14 days and at 4 months after primary PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startSep 2012
- Primary completionMay 2013 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Centre of Serbia
- Sponsor type
- University, hospital or other
- Collaborators
- Center of nuclear medicine, Institute for histology
- Responsible party
- Principal investigator, Dejan Orlic, Clinical Centre of Serbia
- Investigators
- Dejan Orlic, MD, Principal investigator, Clinical Center of Serbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824641
- Sponsor's protocol ID
- T113E4
- Acronym
- PATA-STEMI
- Status last verified
- Apr 2013
- First submitted
- 22 Mar 2013
- Last updated
- 5 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Randomized Physiologic Assessment of Thrombus Aspiration in Patients With Acute ST-segment Elevation Myocardial Infarction Trial
- ClinicalTrials.gov ID
- NCT01824641
- Acronym / sponsor ID
- PATA-STEMI / T113E4
- Conditions
- Myocardial Infarction
- Keywords
- Acute myocardial infarction, Manual thrombus aspiration, Coronary physiology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Clinical Centre of SerbiaUniversity, hospital or other
- Collaborators
- Center of nuclear medicine, Institute for histology
- Study start
- Sep 2012
- Primary completion
- May 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 5 Apr 2013 (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 Physiologic Assessment of Thrombus Aspiration in ST-segment Elevation Myocardial Infarction (PATA-STEMI) trial is a single center, prospective, randomized trial with a planned inclusion of 128 patients with the first ST-segment elevation myocardial infarction (STEMI). Patients are, before coronary angiography, randomly assigned to thrombus aspiration using 6 or 7 French Eliminate aspiration catheter (Terumo Medical Supply, Japan) or to conventional primary percutaneous coronary intervention (PCI). The primary endpoint is index of microcirculatory resistance (IMR), measured in infarct-related artery, in thrombus aspiration compared to conventional PCI group.
Detailed description
Background and Objective Routine thrombus aspiration is superior to conventional primary PCI in terms of improved myocardial perfusion in STEMI patients. However, myocardial perfusion after thrombus aspiration has not been evaluated by a quantitative, invasive method. Investigators intend to determine whether thrombus aspiration of the infarct-related artery increases myocardial perfusion, as measured by IMR, compared to conventional primary PCI.
Study design PATA-STEMI is a single center, prospective, randomized trial with a planned inclusion of 128 patients with the first STEMI. Patients are randomly assigned, before coronary angiography, to thrombus aspiration using the 6 or 7 French Eliminate aspiration catheter (Terumo Medical Supply, Japan) or to conventional primary PCI. The IMR will be determined in infarct-related artery and non-infarct-related arteries without critical stenosis to measure microcirculatory resistance. The primary endpoint is defined as IMR in infarct-related artery in thrombus aspiration compared to conventional PCI group. Secondary end points are myocardial perfusion grade and resolution of ST-segment elevation, infarct size and left ventricle remodeling, as assessed by echocardiographic indices. Transthoracic echocardiography will be conducted within 24 hours and at 4 months after the primary PCI.
Implications: If manual thrombus aspiration reduces microcirculatory resistance, indicating improved myocardial perfusion, as compared to conventional PCI, it might become the preferred strategy in patients with STEMI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eliminate | Experimental | Device: Eliminate aspiration catheterEliminate aspiration catheter |
| Conventional primary angioplasty | Active comparator | Procedure: Conventional primary angioplastyPatients treated with conventional primary angioplasty |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All consecutive patients with STEMI
- chest pain onset ≤12h, or >12 h with persistent ST-segment elevation
- hemodynamically stable patients
Key exclusion criteria (8 listed)
- patients without diagnosis of STEMI (pericarditis, for example)
- no written informed consent obtained
- prior Q or non-Q MI
- prior resuscitation
- prior thrombolysis
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 |
|---|---|---|
| Eliminate aspiration catheterEliminate aspiration catheter | Device | Eliminate |
| Conventional primary angioplastyPrimary angioplasty without thrombus aspiration | Procedure or surgery | Conventional primary angioplasty |
Primary outcome
IMR (mmHg seconds) in thrombus aspiration compared to conventional PCI group
Time frame: At the end of the primary PCI , an expected average of 45 minutes after sheath insertion
IMR will be measured after final balloon inflation or stent implantation, an expected average of 45 minutes after sheath insertion
5 secondary outcomes
Resolution of ST-segment elevation
Time frame: at 60 minutes after guiding catheter removal
myocardial blush grade (0-3)
Time frame: at final angiogram, an expected average of 55 minutes after sheath insertion
infarct size assessed by peak enzyme release (Troponin, creatine kinase MB (CK-MB))
Time frame: in hospital course after primary PCI, an expected average of 5 days
indices of left ventricle remodeling on Echocardiography
Time frame: within 24 hours and at 4 months after primary PCI
infarct size determined by SPECT
Time frame: within 7-14 days and at 4 months after primary PCI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2013.
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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.
Dejan Orlic, MD principal investigator
Clinical Center of Serbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eliminate aspiration catheter and Conventional primary angioplasty in people with Myocardial Infarction, run by Clinical Centre of Serbia at 2 sites in Serbia.
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 8 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: status not confirmed, as of the sponsor's last update on 5 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Serbia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dejan Milasinovic, MD (+381113613653, dejan_milasinovic@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IMR (mmHg seconds) in thrombus aspiration compared to conventional PCI group (time frame: At the end of the primary PCI , an expected average of 45 minutes after sheath insertion). 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 5 Apr 2013.