Thrombus Aspiration in ThrOmbus Containing culpRiT Lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI)
2017年5月1日 更新者：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.
調査の概要
研究の種類
介入
入学 (予想される)
400
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Bad Berka、ドイツ
- Zentralklinik Bad Berka
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Berlin、ドイツ
- Unfallkrankenhaus Berlin
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Frankfurt/Oder、ドイツ
- Klinikum Frankfurt/Oder
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Homburg、ドイツ
- University of Saarland, Campus Homburg/Saar
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Leipzig、ドイツ
- University of Leipzig
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Ludwigshafen、ドイツ
- Institut für Herzinfarktforschung
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Tübingen、ドイツ
- University of Tübingen
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～90年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：血栓摘出術
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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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他の：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
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Extent of late microvascular obstruction assessed by cardiac magnetic resonance imaging (CMR)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Infarct size assessed by cardiac magnetic resonance imaging (CMR)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：Immediately after percutaneous coronary intervention
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Immediately after percutaneous coronary intervention
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Myocardial blush grade
時間枠：Immediately after percutaneous coronary intervention
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Immediately after percutaneous coronary intervention
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Troponin T
時間枠：24 and 48 hours after randomization
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24 and 48 hours after randomization
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Combined clinical endpoint
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Holger Thiele, MD、Heart Center Leipzig, University of Leipzig, Germany
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年3月1日
一次修了 (実際)
2013年6月1日
研究の完了 (実際)
2016年10月1日
試験登録日
最初に提出
2012年5月30日
QC基準を満たした最初の提出物
2012年6月1日
最初の投稿 (見積もり)
2012年6月5日
学習記録の更新
投稿された最後の更新 (実際)
2017年5月2日
QC基準を満たした最後の更新が送信されました
2017年5月1日
最終確認日
2017年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。