Thrombus Aspiration in ThrOmbus Containing culpRiT Lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI)
This study is currently recruiting participants.
Verified June 2012 by University of Leipzig
Sponsor:
University of Leipzig
Information provided by (Responsible Party):
Holger Thiele, University of Leipzig
ClinicalTrials.gov Identifier:
NCT01612312
First received: May 30, 2012
Last updated: June 7, 2012
Last verified: June 2012
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Purpose
Whereas thrombus aspiration in patients with ST-elevation myocardial infarction (STEMI) is recommended by current guidelines, there are insufficient data to unequivocally support thrombectomy in patients with non-STEMI (NSTEMI). The Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI) trial is a 400 patient, prospective, controlled, multicenter, randomized, open-label trial. The hypothesis is that under the background of early revascularization, adjunctive thrombectomy in comparison to conventional percutaneous coronary intervention (PCI) alone leads to less microvascular obstruction (MO) assessed by cardiac magnetic resonance imaging (CMR) in patients with NSTEMI. Patients will be randomized in a 1:1 fashion to one of the two treatment arms. The primary endpoint is the extent of MO assessed by CMR. Secondary endpoints include infarct size and myocardial salvage assessed by CMR, enzymatic infarct size as well as angiographic parameters, such as Thrombolysis in Myocardial Infarction-flow post-PCI and myocardial blush grade. Furthermore, clinical endpoints including death, myocardial reinfarction, target vessel revascularization and new congestive heart failure will be recorded at 6 and 12 months. Safety will be assessed by bleeding and stroke. In summary, the TATORT-NSTEMI trial has been designed to test the hypothesis that thrombectomy will improve myocardial perfusion in patients with NSTEMI and relevant thrombus burden in the culprit vessel reperfused by early PCI.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-ST-elevation Myocardial Infarction |
Procedure: Thrombectomy Procedure: Standard percutaneous coronary intervention |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Thrombus Aspiration in ThrOmbus Containing culpRiT Lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI) |
Resource links provided by NLM:
Further study details as provided by University of Leipzig:
Primary Outcome Measures:
- Extent of late microvascular obstruction assessed by cardiac magnetic resonance imaging (CMR) [ Time Frame: CMR performed within day 1 to 4 after randomization ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Infarct size assessed by cardiac magnetic resonance imaging (CMR) [ Time Frame: CMR performed within day 1 to 4 after randomization ] [ Designated as safety issue: No ]
- Myocardial salvage assessed by cardiac magnetic resonance imaging (CMR) [ Time Frame: CMR performed within day 1 to 4 after randomization ] [ Designated as safety issue: No ]
- Left ventricular ejection fraction assessed by cardiac magnetic resonance imaging (CMR) [ Time Frame: CMR performed within day 1 to 4 after randomization ] [ Designated as safety issue: No ]
- Thrombolysis in Myocardial Infarction (TIMI)-flow post-PCI [ Time Frame: Immediately after percutaneous coronary intervention ] [ Designated as safety issue: No ]
- Myocardial blush grade [ Time Frame: Immediately after percutaneous coronary intervention ] [ Designated as safety issue: No ]
- Troponin T [ Time Frame: 24 and 48 hours after randomization ] [ Designated as safety issue: No ]
- Combined clinical endpoint [ Time Frame: Follow-up performed at 6 and 12 months after randomization ] [ Designated as safety issue: No ]Occurence of a combined clinical endpoint including death, re-infarction, target vessel revascularization and congestive heart failure will be recorded. Clinical outcome will be assessed by a telephone interview at 6 and 12 months. Any clinical event will be verified by hospital or general practitioner records.
- Assessment of quality of life [ Time Frame: 6 and 12 months after randomization ] [ Designated as safety issue: No ]
- Stroke and bleeding [ Time Frame: Participants will be followed for the duration of hospital stay (an expected average of 5 days) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 400 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Thrombectomy |
Procedure: Thrombectomy
Manual thrombectomy will be performed in the thrombus aspiration group using an aspiration catheter utilized in daily clinical routine (Eliminate, Terumo Europe, Leuven, Belgium). In the standard PCI group, patients will be treated by conventional PCI according to local practice without thrombectomy.
|
|
Standard percutaneous coronary intervention
In the standard percutaneous coronary intervention (PCI) group, patients will be treated by conventional PCI according to local practice without thrombectomy.
|
Procedure: Standard percutaneous coronary intervention
In the standard percutaneous coronary intervention (PCI) group, patients will be treated by conventional PCI according to local practice without thrombectomy.
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- ischemic symptoms such as angina pectoris >20 minutes
- occurrence of last symptoms <72 h before randomization
- cardiac troponin T or I levels above the 99th percentile
- culprit lesion containing thrombus (TIMI-thrombus grade 2-5 within the lesion) and intended early PCI
Exclusion Criteria:
- cardiogenic shock
- STEMI
- no identifiable culprit lesion or a TIMI-thrombus grade <2
- coronary morphology ineligible for thrombectomy (e.g. very tortuous vessels, severe calcification)
- indication for acute bypass surgery
- age <18 and >90 years
- contraindications for treatment with heparin, aspirin or thienopyridines
- pregnancy
- current participation in another clinical study
- co-morbidity with limited life expectancy <6 months
- contraindications to CMR at study entry
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01612312
Contacts
| Contact: Holger Thiele, MD | + 49 341 865 1427 | thielh@medizin.uni-leipzig.de |
Locations
| Germany | |
| Zentralklinik Bad Berka | Recruiting |
| Bad Berka, Germany | |
| Contact: Bernward Lauer, MD | |
| Principal Investigator: Bernward Lauer, MD | |
| Unfallkrankenhaus Berlin | Recruiting |
| Berlin, Germany | |
| Contact: Leonard Bruch, MD | |
| Principal Investigator: Leonard Bruch, MD | |
| Klinikum Frankfurt/Oder | Recruiting |
| Frankfurt/Oder, Germany | |
| Contact: Oliver Gunkel, MD | |
| Principal Investigator: Oliver Gunkel, MD | |
| University of Saarland, Campus Homburg/Saar | Recruiting |
| Homburg, Germany | |
| Contact: Bruno Scheller, MD | |
| Principal Investigator: Bruno Scheller, MD | |
| University of Leipzig | Recruiting |
| Leipzig, Germany | |
| Contact: Norbert Klein, MD | |
| Principal Investigator: Norbert Klein, MD | |
| Institut für Herzinfarktforschung | Active, not recruiting |
| Ludwigshafen, Germany | |
| University of Tübingen | Recruiting |
| Tübingen, Germany | |
| Contact: Tobias Geisler, MD | |
| Principal Investigator: Tobias Geisler, MD | |
Sponsors and Collaborators
University of Leipzig
Investigators
| Principal Investigator: | Holger Thiele, MD | Heart Center Leipzig, University of Leipzig, Germany |
More Information
No publications provided
| Responsible Party: | Holger Thiele, Co-Director, Department of Internal Medicine/Cardiology, Heart Center Leipzig, University of Leipzig, Germany, University of Leipzig |
| ClinicalTrials.gov Identifier: | NCT01612312 History of Changes |
| Other Study ID Numbers: | 070-11-07032011 |
| Study First Received: | May 30, 2012 |
| Last Updated: | June 7, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University of Leipzig:
|
Non-ST-elevation myocardial infarction thrombectomy magnetic resonance imaging microvascular obstruction |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Thrombosis Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Embolism and Thrombosis |
ClinicalTrials.gov processed this record on May 23, 2013