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

October 23, 2017 updated by: Population Health Research Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

18000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with ST elevation myocardial infarction undergoing emergency percutaneous coronary intervention

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Thrombus aspiration
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of Cardiovascular death
Time Frame: up to 30 days
time to event analysis
up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of Cardiovascular death
Time Frame: up to 180 days
time to event analysis
up to 180 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of Stroke
Time Frame: up to 30 days
time to event analysis
up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Population Health Research Institute

Collaborators

Uppsala University
University Medical Center Groningen
Region Örebro County
University of Groningen

Investigators

  • Principal Investigator: Sanjit S Jolly, MD, Population Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

September 10, 2015

First Submitted That Met QC Criteria

September 15, 2015

First Posted (Estimate)

September 17, 2015

Study Record Updates

Last Update Posted (Actual)

October 25, 2017

Last Update Submitted That Met QC Criteria

October 23, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ThrombectomyMetaAnalysis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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