Effect of Thrombus Aspiration in Patients With Myocardial Infarction Presenting Late After Symptom Onset

Phase 4

Completed

• Conditions: Myocardial Infarction
• Interventions: Device: manual thrombus aspiration (Export catheter, Medtronic Inc. Minneapolis, Minnesota, USA)

• Registration Number: NCT01379248
• Lead Sponsor: University of Leipzig

Brief Summary

The purpose of this study is to examine the benefit of thrombus aspiration in patients with ST-elevation myocardial infarction presenting late after symptom onset.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-20
• Study First Submitted QC: 2011-06-21
• Study First Posted: 2011-06-23
• Primary Completion: 2014-11
• Study Completion: 2015-05
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

• ST-elevation myocardial infarction >12 and <48 hours after symptom onset
• age 18 to 90 years
• informed consent

Exclusion Criteria

• prior fibrinolysis
• severe comorbidities with limited life expectancy
• pregnancy
• patient unable to give informed consent
• participation in another trial
• contraindications for heparin, aspirin or thienopyridines
• contraindications for cardiac magnetic resonance examination

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
thrombus aspiration	manual thrombus aspiration (Export catheter, Medtronic Inc. Minneapolis, Minnesota, USA)	Manual thrombus aspiration with dedicated catheter (Export, Medtronic Inc. Minneapolis, Minnesota, USA)

Primary Outcome Measures

Name	Time	Method
Microvascular obstruction (cardiac magnetic resonance imaging)	1-4 days after randomization

Trial Locations

Locations (1)

University of Leipzig Heart Center; 🇩🇪 Leipzig, Germany