Myocardial InfarctionPhase 4NCT01379248
Effect of Thrombus Aspiration in Patients With Myocardial Infarction Presenting Late After Symptom Onset
A Phase 4 study testing manual thrombus aspiration (Export catheter, Medtronic Inc. Minneapolis, Minnesota, USA) in people with Myocardial Infarction, run by University of Leipzig at 1 site in Germany.
Trial summary
The purpose of this study is to examine the benefit of thrombus aspiration in patients with ST-elevation myocardial infarction presenting late after symptom onset. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- manual thrombus aspiration (Export catheter, Medtronic Inc. Minneapolis, Minnesota, USA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2011to May 2015
- Phase
- Phase 4
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ST-elevation myocardial infarction >12 and <48 hours after symptom onset
- age 18 to 90 years
- informed consent
Who cannot join
- prior fibrinolysis
- severe comorbidities with limited life expectancy
- pregnancy
- patient unable to give informed consent
- participation in another trial
- contraindications for heparin, aspirin or thienopyridines
- contraindications for cardiac magnetic resonance examination
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the benefit of thrombus aspiration in patients with ST-elevation myocardial infarction presenting late after symptom onset.
- Conditions
- Myocardial Infarction
- Being tested
- manual thrombus aspiration (Export catheter, Medtronic Inc. Minneapolis, Minnesota, USA)
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual thrombus aspiration (Export catheter, Medtronic Inc. Minneapolis, Minnesota, USA)Device
manual thrombus aspiration catheter to be used during percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| thrombus aspiration | Experimental | Manual thrombus aspiration with dedicated catheter (Export, Medtronic Inc. Minneapolis, Minnesota, USA) Receives: Device: manual thrombus aspiration (Export catheter, Medtronic Inc. Minneapolis, Minnesota, USA) |
| no thrombus aspiration | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular obstruction (cardiac magnetic resonance imaging)
Measured: 1-4 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionNov 2014
- Study completionMay 2015
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steffen Desch, MD, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379248
- Sponsor's protocol ID
- STEMI-Late-Presenter
- Status last verified
- Oct 2016
- First submitted
- 20 Jun 2011
- Last updated
- 28 Oct 2016
- Results posted
- No
Publications
Desch S, Stiermaier T, de Waha S, Lurz P, Gutberlet M, Sandri M, Mangner N, Boudriot E, Woinke M, Erbs S, Schuler G, Fuernau G, Eitel I, Thiele H. Thrombus Aspiration in Patients With ST-Segment Elevation Myocardial Infarction Presenting Late After Symptom Onset. JACC Cardiovasc Interv. 2016 Jan 25;9(2):113-22. doi: 10.1016/j.jcin.2015.09.010.
PubMed 26793952
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thrombus Aspiration in Patients With Myocardial Infarction Presenting Late After Symptom Onset
- ClinicalTrials.gov ID
- NCT01379248
- Acronym / sponsor ID
- STEMI-Late-Presenter
- Conditions
- Myocardial Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 23 Jun 2011 (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 this study is to examine the benefit of thrombus aspiration in patients with ST-elevation myocardial infarction presenting late after symptom onset.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thrombus aspiration | Experimental | Device: manual thrombus aspiration (Export catheter, Medtronic Inc. Minneapolis, Minnesota, USA)Manual thrombus aspiration with dedicated catheter (Export, Medtronic Inc. Minneapolis, Minnesota, USA) |
| no thrombus aspiration | No intervention | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ST-elevation myocardial infarction >12 and <48 hours after symptom onset
- age 18 to 90 years
- informed consent
Key exclusion criteria (7 listed)
- prior fibrinolysis
- severe comorbidities with limited life expectancy
- pregnancy
- patient unable to give informed consent
- participation in another trial
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 |
|---|---|---|
| manual thrombus aspiration (Export catheter, Medtronic Inc. Minneapolis, Minnesota, USA)manual thrombus aspiration catheter to be used during percutaneous coronary intervention | Device | thrombus aspiration |
Primary outcome
Microvascular obstruction (cardiac magnetic resonance imaging)
Time frame: 1-4 days after randomization
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 28 Oct 2016.
- Derived from this study: PubMed 26793952Desch S, Stiermaier T, de Waha S, Lurz P, Gutberlet M, Sandri M, Mangner N, Boudriot E, Woinke M, Erbs S, Schuler G, Fuernau G, Eitel I, Thiele H. Thrombus Aspiration in Patients With ST-Segment Elevation Myocardial Infarction Presenting Late After Symptom Onset. JACC Cardiovasc Interv. 2016 Jan 25;9(2):113-22. doi: 10.1016/j.jcin.2015.09.010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing manual thrombus aspiration (Export catheter, Medtronic Inc. Minneapolis, Minnesota, USA) in people with Myocardial Infarction, run by University of Leipzig at 1 site in Germany.
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 7 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 28 Oct 2016. 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 Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Microvascular obstruction (cardiac magnetic resonance imaging) (time frame: 1-4 days after randomization). 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 NCT01379248, 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 28 Oct 2016.