Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study
NCT ID: NCT01013038
Last Updated: 2009-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
540 participants
INTERVENTIONAL
2007-12-31
2012-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Thrombectomy in Acute Myocardial Infarction
NCT00675480
Thrombus Aspiration Before Standard Primary Angioplasty Improves Myocardial Reperfusion in Acute Myocardial Infarction.
NCT00257153
Aspiration Device in Myocardial Infarction Trial
NCT00370578
Effect of Thrombus Aspiration in Patients With Myocardial Infarction Presenting Late After Symptom Onset
NCT01379248
A Trial of Routine Aspiration Thrombectomy With Percutaneous Coronary Intervention (PCI) Versus PCI Alone in Patients With ST-Segment Elevation Myocardial Infarction (STEMI) Undergoing Primary PCI
NCT01149044
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study is a single-centre, prospective, randomised trial with blinded evaluation of endpoints. The planned inclusion is 540 patients with acute NSTEMI who are candidates for urgent PCI.
If thrombus aspiration leads to significant improvement of myocardial perfusion in patients with acute NSTEMI it may become part of the standard interventional approach.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Conventional percutaneous coronary intervention
conventional PCI
balloon angioplasty and/or stent implantation
Thrombus aspiration
Thrombus aspiration followed by stent implantation
Export aspiration catheter 6F (Medtronics)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Thrombus aspiration followed by stent implantation
Export aspiration catheter 6F (Medtronics)
conventional PCI
balloon angioplasty and/or stent implantation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Chest pain suggestive for myocardial ischemia for at least 30 minutes,
* Time from onset of symptoms of less than 72 hours
* ECG with ST-segment shifts (depression of \>0.1 mV in at least two contiguous leads or transient ST-segment elevation \>0.1 mV in at least two contiguous leads for less than 30 minutes) and/or T-wave changes (inversion of \>0.15 mV in at least two contiguous leads)
* Positive cardiac troponin T \>0,01 μg/L.
* Clinical indication for urgent PCI of the ischemia-related target lesion as identified at coronary angiography
Exclusion Criteria
* Presence of cardiogenic shock
* Inability to obtain informed consent
* Known existence of a life-threatening disease with a life expectancy of less than 6 months
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Netherlands Heart Foundation
OTHER
University Medical Center Groningen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
University Medical Center Groningen, Thoraxcenter
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Medical Center Groningen
Groningen, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2008B101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.