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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02552407
• Other study ID #: ThrombectomyMetaAnalysis
• Status: Completed
• Phase: N/A
• First received: September 10, 2015
• Last updated: October 23, 2017
• Start date: September 2015
• Est. completion date: November 2016

Study information

• Verified date: October 2017
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 microvascular perfusion and reduce mortality.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18000
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Device:
• Manual Aspiration Thrombectomy
Thrombus aspiration

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Population Health Research Institute	Region Örebro County, University Medical Center Groningen, University of Groningen, Uppsala University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Occurrence of Stroke	time to event analysis	up to 30 days
Primary	Occurrence of Cardiovascular death	time to event analysis	up to 30 days
Secondary	Occurrence of Cardiovascular death	time to event analysis	up to 180 days