NCT01612312

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2011

Longer than P75 for phase_4

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 5, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

May 2, 2017

Status Verified

May 1, 2017

Enrollment Period

2.3 years

First QC Date

May 30, 2012

Last Update Submit

May 1, 2017

Conditions

Non-ST-elevation Myocardial Infarction

Keywords

Non-ST-elevation myocardial infarctionthrombectomymagnetic resonance imagingmicrovascular obstruction

Outcome Measures

Primary Outcomes (1)

  • Extent of late microvascular obstruction assessed by cardiac magnetic resonance imaging (CMR)

    CMR performed within day 1 to 4 after randomization

Secondary Outcomes (9)

  • Infarct size assessed by cardiac magnetic resonance imaging (CMR)

    CMR performed within day 1 to 4 after randomization

  • Myocardial salvage assessed by cardiac magnetic resonance imaging (CMR)

    CMR performed within day 1 to 4 after randomization

  • Left ventricular ejection fraction assessed by cardiac magnetic resonance imaging (CMR)

    CMR performed within day 1 to 4 after randomization

  • Thrombolysis in Myocardial Infarction (TIMI)-flow post-PCI

    Immediately after percutaneous coronary intervention

  • Myocardial blush grade

    Immediately after percutaneous coronary intervention

  • +4 more secondary outcomes

Study Arms (2)

Thrombectomy

ACTIVE COMPARATOR
Procedure: Thrombectomy

Standard percutaneous coronary intervention

OTHER

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

Interventions

ThrombectomyPROCEDURE

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.

Thrombectomy
Standard percutaneous coronary interventionPROCEDURE

In the standard percutaneous coronary intervention (PCI) group, patients will be treated by conventional PCI according to local practice without thrombectomy.

Standard percutaneous coronary intervention

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Zentralklinik Bad Berka

Bad Berka, Germany

Location

Unfallkrankenhaus Berlin

Berlin, Germany

Location

Klinikum Frankfurt/Oder

Frankfurt (Oder), Germany

Location

University of Saarland, Campus Homburg/Saar

Homburg, Germany

Location

University of Leipzig

Leipzig, Germany

Location

Institut für Herzinfarktforschung

Ludwigshafen, Germany

Location

University of Tübingen

Tübingen, Germany

Location

Related Publications (11)

  • Lange T, Backhaus SJ, Schulz A, Evertz R, Kowallick JT, Bigalke B, Hasenfuss G, Thiele H, Stiermaier T, Eitel I, Schuster A. Cardiovascular magnetic resonance-derived left atrioventricular coupling index and major adverse cardiac events in patients following acute myocardial infarction. J Cardiovasc Magn Reson. 2023 Apr 13;25(1):24. doi: 10.1186/s12968-023-00929-w.

    PMID: 37046343DERIVED

  • 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.

    PMID: 36268539DERIVED

  • 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.

    PMID: 35851282DERIVED

  • 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.

    PMID: 33083869DERIVED

  • 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.

    PMID: 32873121DERIVED

  • 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.

    PMID: 32335515DERIVED

  • 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.

    PMID: 32030497DERIVED

  • 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.

    PMID: 31329854DERIVED

  • 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.

    PMID: 31278521DERIVED

  • 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.

    PMID: 25212646DERIVED

  • 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.

    PMID: 23782681DERIVED

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction

Interventions

Thrombectomy

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Vascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Holger Thiele, MD

    Heart Center Leipzig, University of Leipzig, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Director, Department of Internal Medicine/Cardiology, Heart Center Leipzig, University of Leipzig, Germany

Study Record Dates

First Submitted

May 30, 2012

First Posted

June 5, 2012

Study Start

March 1, 2011

Primary Completion

June 1, 2013

Study Completion

October 1, 2016

Last Updated

May 2, 2017

Record last verified: 2017-05

Locations

DE(7)