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CompletedNCT02552407Updated Oct 25, 2017

Thrombectomy in ST Elevation Myocardial Infarction, an Individual Patient Meta-analysis

An observational study in Myocardial Infarction and Acute Coronary Syndromes, sponsored by Population Health Research Institute. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-25.

Sponsored by Population Health Research Institute · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
18,000
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Myocardial Infarction
  • Acute Coronary Syndromes

Keywords

  • thrombectomy
  • acute coronary syndromes
  • percutaneous coronary intervention
  • STEMI
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's planned enrollment of 18,000 is above the median of 500 across 983 observational studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Population Health Research Institute is the lead sponsor of 114 studies on the registry; 27 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with ST elevation myocardial infarction undergoing emergency percutaneous coronary intervention

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

-

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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
18,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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).

    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.

Interventions

  • DeviceManual Aspiration Thrombectomy

    Thrombus aspiration

06

What researchers measure

Primary outcomes

  1. Occurrence of Cardiovascular death

    time to event analysis

    Time frame: up to 30 days

Secondary outcomes

  1. Occurrence of Cardiovascular death

    time to event analysis

    Time frame: up to 180 days

Other outcomes

  1. Occurrence of Stroke

    time to event analysis

    Time frame: up to 30 days

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Study locations

No study locations are listed for this record.

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References and documents

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 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02552407
Lead sponsor
Population Health Research Institute
Collaborators
Uppsala University, Region Örebro County, University Medical Center Groningen, University of Groningen
Responsible party
Sponsor
First posted
Sep 17, 2015
Start date
Sep 2015
Primary completion
Nov 2016
Completion
Nov 2016
Last update
Oct 25, 2017

Study contacts

Sanjit S Jolly, MD
principal investigator · Population Health Research Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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