Clinical trial NCT01612312: Thrombus Aspiration in ThrOmbus Containing culpRiT Lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI)
Official title: Thrombus Aspiration in ThrOmbus Containing culpRiT Lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-ST-elevation Myocardial Infarction
Keywords: Non-ST-elevation myocardial infarction
thrombectomy
magnetic resonance imaging
microvascular obstruction
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2012-06-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Extent of late microvascular obstruction assessed by cardiac magnetic resonance imaging (CMR)
timeFrame: CMR performed within day 1 to 4 after randomization
Secondary outcomes:
measure: Infarct size assessed by cardiac magnetic resonance imaging (CMR)
timeFrame: CMR performed within day 1 to 4 after randomization
measure: Myocardial salvage assessed by cardiac magnetic resonance imaging (CMR)
timeFrame: CMR performed within day 1 to 4 after randomization
measure: Left ventricular ejection fraction assessed by cardiac magnetic resonance imaging (CMR)
timeFrame: CMR performed within day 1 to 4 after randomization
measure: Thrombolysis in Myocardial Infarction (TIMI)-flow post-PCI
timeFrame: Immediately after percutaneous coronary intervention
measure: Myocardial blush grade
timeFrame: Immediately after percutaneous coronary intervention
measure: Troponin T
timeFrame: 24 and 48 hours after randomization
measure: Combined clinical endpoint
timeFrame: Follow-up performed at 6, 12 and approximately 60 months after randomization
measure: Assessment of quality of life
timeFrame: 6, 12 and approximately 60 months after randomization
measure: Stroke and bleeding
timeFrame: Participants will be followed for the duration of hospital stay (an expected average of 5 days)
Other outcomes:
Locations:
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka
city: Berlin
country: Germany
facility: Unfallkrankenhaus Berlin
city: Frankfurt/Oder
country: Germany
facility: Klinikum Frankfurt/Oder
city: Homburg
country: Germany
facility: University of Saarland, Campus Homburg/Saar
city: Leipzig
country: Germany
facility: University of Leipzig
city: Ludwigshafen
country: Germany
facility: Institut für Herzinfarktforschung
city: Tübingen
country: Germany
facility: University of Tübingen
Study officials:
affiliation: Heart Center Leipzig, University of Leipzig, Germany
name: Holger Thiele, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Backhaus SJ, Aldehayat H, Kowallick JT, Evertz R, Lange T, Kutty S, Bigalke B, Gutberlet M, Hasenfuss G, Thiele H, Stiermaier T, Eitel I, Schuster A. Artificial intelligence fully automated myocardial strain quantification for risk stratification following acute myocardial infarction. Sci Rep. 2022 Jul 18;12(1):12220. doi: 10.1038/s41598-022-16228-w.
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