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NCT01379248 Clinical Trial

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

Myocardial Infarction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01379248
Other study ID # STEMI-Late-Presenter
Secondary ID
Status Completed
Phase Phase 4
First received June 20, 2011
Last updated October 27, 2016
Start date June 2011
Est. completion date May 2015

Study information
Verified date October 2016
Source University of Leipzig
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 152
Est. completion date May 2015
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• manual thrombus aspiration (Export catheter, Medtronic Inc. Minneapolis, Minnesota, USA)
manual thrombus aspiration catheter to be used during percutaneous coronary intervention

Locations
Country Name City State
Germany University of Leipzig Heart Center Leipzig

Sponsors (1)
Lead Sponsor Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Microvascular obstruction (cardiac magnetic resonance imaging) 1-4 days after randomization No
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