Overview

This trial is active, not recruiting.

Conditions myocardial infarction, acute coronary syndromes
Treatment manual aspiration thrombectomy
Sponsor Population Health Research Institute
Collaborator Uppsala University
Start date September 2015
End date November 2016
Trial size 18000 participants
Trial identifier NCT02552407, ThrombectomyMetaAnalysis

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective retrospective
Arm
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).
manual aspiration thrombectomy
Thrombus aspiration
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.

Primary Outcomes

Measure
Occurrence of Cardiovascular death
time frame: up to 30 days

Secondary Outcomes

Measure
Occurrence of Cardiovascular death
time frame: up to 180 days

Eligibility Criteria

Male or female participants at least 18 years old.

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:

Additional Information

Official title Thrombectomy in ST Elevation Myocardial Infarction, an Individual Patient Meta-analysis
Principal investigator Sanjit S Jolly, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Population Health Research Institute.