Thrombus Aspiration in ThrOmbus Containing culpRiT Lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI)
1 mei 2017 bijgewerkt door: Holger Thiele, University of Leipzig
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Verwacht)
400
Fase
- Fase 4
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Bad Berka, Duitsland
- Zentralklinik Bad Berka
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Berlin, Duitsland
- Unfallkrankenhaus Berlin
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Frankfurt/Oder, Duitsland
- Klinikum Frankfurt/Oder
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Homburg, Duitsland
- University of Saarland, Campus Homburg/Saar
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Leipzig, Duitsland
- University of Leipzig
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Ludwigshafen, Duitsland
- Institut für Herzinfarktforschung
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Tübingen, Duitsland
- University of Tübingen
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 90 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: Trombectomie
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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.
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Ander: 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.
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In the standard percutaneous coronary intervention (PCI) group, patients will be treated by conventional PCI according to local practice without thrombectomy.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Extent of late microvascular obstruction assessed by cardiac magnetic resonance imaging (CMR)
Tijdsspanne: CMR performed within day 1 to 4 after randomization
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CMR performed within day 1 to 4 after randomization
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Infarct size assessed by cardiac magnetic resonance imaging (CMR)
Tijdsspanne: CMR performed within day 1 to 4 after randomization
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CMR performed within day 1 to 4 after randomization
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Myocardial salvage assessed by cardiac magnetic resonance imaging (CMR)
Tijdsspanne: CMR performed within day 1 to 4 after randomization
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CMR performed within day 1 to 4 after randomization
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Left ventricular ejection fraction assessed by cardiac magnetic resonance imaging (CMR)
Tijdsspanne: CMR performed within day 1 to 4 after randomization
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CMR performed within day 1 to 4 after randomization
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Thrombolysis in Myocardial Infarction (TIMI)-flow post-PCI
Tijdsspanne: Immediately after percutaneous coronary intervention
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Immediately after percutaneous coronary intervention
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Myocardial blush grade
Tijdsspanne: Immediately after percutaneous coronary intervention
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Immediately after percutaneous coronary intervention
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Troponin T
Tijdsspanne: 24 and 48 hours after randomization
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24 and 48 hours after randomization
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Combined clinical endpoint
Tijdsspanne: Follow-up performed at 6, 12 and approximately 60 months after randomization
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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.
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Follow-up performed at 6, 12 and approximately 60 months after randomization
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Assessment of quality of life
Tijdsspanne: 6, 12 and approximately 60 months after randomization
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6, 12 and approximately 60 months after randomization
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Stroke and bleeding
Tijdsspanne: Participants will be followed for the duration of hospital stay (an expected average of 5 days)
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Participants will be followed for the duration of hospital stay (an expected average of 5 days)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Holger Thiele, MD, Heart Center Leipzig, University of Leipzig, Germany
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Backhaus SJ, Rosel SF, Stiermaier T, Schmidt-Rimpler J, Evertz R, Schulz A, Lange T, Kowallick JT, Kutty S, Bigalke B, Gutberlet M, Hasenfuss G, Thiele H, Eitel I, Schuster A. Left-atrial long-axis shortening allows effective quantification of atrial function and optimized risk prediction following acute myocardial infarction. Eur Heart J Open. 2022 Aug 12;2(5):oeac053. doi: 10.1093/ehjopen/oeac053. eCollection 2022 Sep.
- 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.
- Lange T, Stiermaier T, Backhaus SJ, Boom PC, Kowallick JT, de Waha-Thiele S, Lotz J, Kutty S, Bigalke B, Gutberlet M, Feistritzer HJ, Desch S, Hasenfuss G, Thiele H, Eitel I, Schuster A. Functional and prognostic implications of cardiac magnetic resonance feature tracking-derived remote myocardial strain analyses in patients following acute myocardial infarction. Clin Res Cardiol. 2021 Feb;110(2):270-280. doi: 10.1007/s00392-020-01747-1. Epub 2020 Oct 20.
- Schuster A, Lange T, Backhaus SJ, Strohmeyer C, Boom PC, Matz J, Kowallick JT, Lotz J, Steinmetz M, Kutty S, Bigalke B, Gutberlet M, de Waha-Thiele S, Desch S, Hasenfuss G, Thiele H, Stiermaier T, Eitel I. Fully Automated Cardiac Assessment for Diagnostic and Prognostic Stratification Following Myocardial Infarction. J Am Heart Assoc. 2020 Sep 15;9(18):e016612. doi: 10.1161/JAHA.120.016612. Epub 2020 Sep 2.
- Backhaus SJ, Kowallick JT, Stiermaier T, Lange T, Navarra JL, Koschalka A, Evertz R, Lotz J, Kutty S, Hasenfuss G, Gutberlet M, Thiele H, Eitel I, Schuster A. Cardiac Magnetic Resonance Myocardial Feature Tracking for Optimized Risk Assessment After Acute Myocardial Infarction in Patients With Type 2 Diabetes. Diabetes. 2020 Jul;69(7):1540-1548. doi: 10.2337/db20-0001. Epub 2020 Apr 24.
- Schuster A, Backhaus SJ, Stiermaier T, Kowallick JT, Stulle A, Koschalka A, Lotz J, Kutty S, Bigalke B, Gutberlet M, Hasenfuss G, Thiele H, Eitel I. Fast manual long-axis strain assessment provides optimized cardiovascular event prediction following myocardial infarction. Eur Heart J Cardiovasc Imaging. 2019 Nov 1;20(11):1262-1270. doi: 10.1093/ehjci/jez077.
- Backhaus SJ, Kowallick JT, Stiermaier T, Lange T, Koschalka A, Navarra JL, Lotz J, Kutty S, Bigalke B, Gutberlet M, Feistritzer HJ, Hasenfuss G, Thiele H, Schuster A, Eitel I. Culprit vessel-related myocardial mechanics and prognostic implications following acute myocardial infarction. Clin Res Cardiol. 2020 Mar;109(3):339-349. doi: 10.1007/s00392-019-01514-x. Epub 2019 Jul 5.
- Feistritzer HJ, Meyer-Saraei R, Lober C, Bohm M, Scheller B, Lauer B, Geisler T, Gawaz M, Bruch L, Klein N, Zeymer U, Eitel I, Jobs A, Freund A, Desch S, de Waha-Thiele S, Thiele H. Long-term outcome after thrombus aspiration in non-ST-elevation myocardial infarction: results from the TATORT-NSTEMI trial : Thrombus aspiration in acute myocardial infarction. Clin Res Cardiol. 2020 Oct;109(10):1223-1231. doi: 10.1007/s00392-020-01613-0. Epub 2020 Feb 6.
- Thiele H, de Waha S, Zeymer U, Desch S, Scheller B, Lauer B, Geisler T, Gawaz M, Gunkel O, Bruch L, Klein N, Pfeiffer D, Schuler G, Eitel I. Effect of aspiration thrombectomy on microvascular obstruction in NSTEMI patients: the TATORT-NSTEMI trial. J Am Coll Cardiol. 2014 Sep 16;64(11):1117-24. doi: 10.1016/j.jacc.2014.05.064.
- de Waha S, Eitel I, Desch S, Scheller B, Bohm M, Lauer B, Gawaz M, Geisler T, Gunkel O, Bruch L, Klein N, Pfeiffer D, Schuler G, Zeymer U, Thiele H. Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI): study protocol for a randomized controlled trial. Trials. 2013 Apr 25;14:110. doi: 10.1186/1745-6215-14-110.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 maart 2011
Primaire voltooiing (Werkelijk)
1 juni 2013
Studie voltooiing (Werkelijk)
1 oktober 2016
Studieregistratiedata
Eerst ingediend
30 mei 2012
Eerst ingediend dat voldeed aan de QC-criteria
1 juni 2012
Eerst geplaatst (Schatting)
5 juni 2012
Updates van studierecords
Laatste update geplaatst (Werkelijk)
2 mei 2017
Laatste update ingediend die voldeed aan QC-criteria
1 mei 2017
Laatst geverifieerd
1 mei 2017
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 070-11-07032011
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