Effect of Thrombus Aspiration in Patients With Myocardial Infarction Presenting Late After Symptom Onset
October 27, 2016 updated by: Steffen Desch, MD, University of Leipzig
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
152
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Leipzig, Germany, 04289
- University of Leipzig Heart Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: thrombus aspiration
Manual thrombus aspiration with dedicated catheter (Export, Medtronic Inc. Minneapolis, Minnesota, USA)
|
manual thrombus aspiration catheter to be used during percutaneous coronary intervention
|
|
No Intervention: no thrombus aspiration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Microvascular obstruction (cardiac magnetic resonance imaging)
Time Frame: 1-4 days after randomization
|
1-4 days after randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
June 20, 2011
First Submitted That Met QC Criteria
June 21, 2011
First Posted (Estimate)
June 23, 2011
Study Record Updates
Last Update Posted (Estimate)
October 28, 2016
Last Update Submitted That Met QC Criteria
October 27, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STEMI-Late-Presenter
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.