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

NCT ID: NCT01379248

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2015-05-31

Brief Summary

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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

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Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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thrombus aspiration

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

Group Type EXPERIMENTAL

manual thrombus aspiration (Export catheter, Medtronic Inc. Minneapolis, Minnesota, USA)

Intervention Type DEVICE

manual thrombus aspiration catheter to be used during percutaneous coronary intervention

no thrombus aspiration

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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manual thrombus aspiration (Export catheter, Medtronic Inc. Minneapolis, Minnesota, USA)

manual thrombus aspiration catheter to be used during percutaneous coronary intervention

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Leipzig

OTHER

Sponsor Role lead

Responsible Party

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Steffen Desch, MD

Priv. - Doz. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Leipzig Heart Center

Leipzig, , Germany

Site Status

Countries

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Germany

References

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Desch S, Stiermaier T, de Waha S, Lurz P, Gutberlet M, Sandri M, Mangner N, Boudriot E, Woinke M, Erbs S, Schuler G, Fuernau G, Eitel I, Thiele H. Thrombus Aspiration in Patients With ST-Segment Elevation Myocardial Infarction Presenting Late After Symptom Onset. JACC Cardiovasc Interv. 2016 Jan 25;9(2):113-22. doi: 10.1016/j.jcin.2015.09.010.

Reference Type DERIVED
PMID: 26793952 (View on PubMed)

Other Identifiers

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STEMI-Late-Presenter

Identifier Type: -

Identifier Source: org_study_id