Myocardial InfarctionNCT02552407
Thrombectomy in ST Elevation Myocardial Infarction, an Individual Patient Meta-analysis
An observational study of Myocardial Infarction and Acute Coronary Syndromes, run by Population Health Research Institute.
Trial summary
During primary percutaneous coronary intervention, distal embolization of thrombus and impaired microvascular perfusion has been associated with an increased mortality. Thrombectomy devices during primary percutaneous coronary intervention may prevent distal embolization by reducing thrombus burden and thus improve… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Acute Coronary Syndromes
- What is being tested?
- Manual Aspiration Thrombectomy
- Type of treatment
- Medical device
- How many people
- 18,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Nov 2016
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ST elevation myocardial infarction undergoing emergency percutaneous coronary intervention
Who may be able to join
- Randomized controlled trials comparing manual thrombectomy vs. percutaneous coronary intervention alone in patients with ST elevation myocardial infarction published between January 1980 and April 2015.
- Large trials randomizing more than 1000 patients.
- Trials must have had at least 30 day follow up.
Who cannot join
- -
About this study
During primary percutaneous coronary intervention, distal embolization of thrombus and impaired microvascular perfusion has been associated with an increased mortality. Thrombectomy devices during primary percutaneous coronary intervention may prevent distal embolization by reducing thrombus burden and thus improve microvascular perfusion and reduce mortality.
Read the detailed description
An individual patient meta-analysis of large randomized controlled trials comparing manual thrombectomy versus percutaneous coronary intervention alone in patients with ST elevation myocardial infarction will provide significantly more power to detect differences in mortality as well as important but rare events such as stroke and to assess benefits in pre-defined subgroups.
- Conditions
- Myocardial Infarction, Acute Coronary Syndromes
- Being tested
- Manual Aspiration Thrombectomy
- Keywords
- thrombectomy, acute coronary syndromes, percutaneous coronary intervention, STEMI
- Medical subject headings
- Myocardial Infarction, Acute Coronary Syndrome, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Aspiration ThrombectomyDevice
Thrombus aspiration
| Study group | Role | What they receive |
|---|---|---|
| Manual Aspiration Thrombectomy with PCI | Subjects from the randomized controlled trials to be included in this meta-analysis will have been randomly allocated to Manual Aspiration Thrombectomy followed by percutaneous coronary intervention (PCI). Receives: Device: Manual Aspiration Thrombectomy | |
| PCI Alone | Subjects from the randomized controlled trials to be included in this meta-analysis will have been randomly allocated to percutaneous coronary intervention (PCI) alone without manual aspiration thrombectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Cardiovascular death
time to event analysis
Measured: up to 30 days
Secondary outcomes (1)
Occurrence of Cardiovascular death
time to event analysis
Measured: up to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionNov 2016
- Study completionNov 2016
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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 18,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University, Region Örebro County, University Medical Center Groningen, University of Groningen
- Responsible party
- Sponsor
- Investigators
- Sanjit S Jolly, MD, Principal investigator, Population Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552407
- Sponsor's protocol ID
- ThrombectomyMetaAnalysis
- Status last verified
- Oct 2017
- First submitted
- 10 Sep 2015
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Jolly SS, James S, Dzavik V, Cairns JA, Mahmoud KD, Zijlstra F, Yusuf S, Olivecrona GK, Renlund H, Gao P, Lagerqvist B, Alazzoni A, Kedev S, Stankovic G, Meeks B, Frobert O. Thrombus Aspiration in ST-Segment-Elevation Myocardial Infarction: An Individual Patient Meta-Analysis: Thrombectomy Trialists Collaboration. Circulation. 2017 Jan 10;135(2):143-152. doi: 10.1161/CIRCULATIONAHA.116.025371. Epub 2016 Dec 9.
PubMed 27941066
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombectomy in ST Elevation Myocardial Infarction, an Individual Patient Meta-analysis
- ClinicalTrials.gov ID
- NCT02552407
- Acronym / sponsor ID
- ThrombectomyMetaAnalysis
- Conditions
- Myocardial Infarction, Acute Coronary Syndromes
- Keywords
- thrombectomy, acute coronary syndromes, percutaneous coronary intervention, STEMI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18,000 participants (estimated)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Collaborators
- Uppsala University, Region Örebro County, University Medical Center Groningen, University of Groningen
- Study start
- Sep 2015 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 17 Sep 2015 (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.
During primary percutaneous coronary intervention, distal embolization of thrombus and impaired microvascular perfusion has been associated with an increased mortality. Thrombectomy devices during primary percutaneous coronary intervention may prevent distal embolization by reducing thrombus burden and thus improve microvascular perfusion and reduce mortality.
Detailed description
An individual patient meta-analysis of large randomized controlled trials comparing manual thrombectomy versus percutaneous coronary intervention alone in patients with ST elevation myocardial infarction will provide significantly more power to detect differences in mortality as well as important but rare events such as stroke and to assess benefits in pre-defined subgroups.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Aspiration Thrombectomy with PCI | – | Device: Manual Aspiration ThrombectomySubjects from the randomized controlled trials to be included in this meta-analysis will have been randomly allocated to Manual Aspiration Thrombectomy followed by percutaneous coronary intervention (PCI). |
| PCI Alone | – | –Subjects from the randomized controlled trials to be included in this meta-analysis will have been randomly allocated to percutaneous coronary intervention (PCI) alone without manual aspiration thrombectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ST elevation myocardial infarction undergoing emergency percutaneous coronary intervention
Key inclusion criteria (3 listed)
- Randomized controlled trials comparing manual thrombectomy vs. percutaneous coronary intervention alone in patients with ST elevation myocardial infarction published between January 1980 and April 2015.
- Large trials randomizing more than 1000 patients.
- Trials must have had at least 30 day follow up.
Key exclusion criteria (1 listed)
- -
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 Aspiration ThrombectomyThrombus aspiration | Device | Manual Aspiration Thrombectomy with PCI |
Primary outcome
Occurrence of Cardiovascular death
Time frame: up to 30 days
time to event analysis
1 secondary outcome
Occurrence of Cardiovascular death
Time frame: up to 180 days
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 25 Oct 2017.
- Derived from this study: PubMed 27941066Jolly SS, James S, Dzavik V, Cairns JA, Mahmoud KD, Zijlstra F, Yusuf S, Olivecrona GK, Renlund H, Gao P, Lagerqvist B, Alazzoni A, Kedev S, Stankovic G, Meeks B, Frobert O. Thrombus Aspiration in ST-Segment-Elevation Myocardial Infarction: An Individual Patient Meta-Analysis: Thrombectomy Trialists Collaboration. Circulation. 2017 Jan 10;135(2):143-152. doi: 10.1161/CIRCULATIONAHA.116.025371. Epub 2016 Dec 9.
- Individual participant dataSharing planned: Undecided
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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.
Sanjit S Jolly, MD principal investigator
Population Health Research Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Acute Coronary Syndromes, run by Population Health Research Institute.
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 1 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 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Occurrence of Cardiovascular death (time frame: up to 30 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 NCT02552407, 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 25 Oct 2017.