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Non-ST-elevation Myocardial InfarctionPhase 4NCT01612312

Thrombus Aspiration in ThrOmbus Containing culpRiT Lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI)

A Phase 4 study testing Thrombectomy and Standard percutaneous coronary intervention in people with Non-ST-elevation Myocardial Infarction, run by University of Leipzig at 7 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Non-ST-elevation Myocardial Infarction
What is being tested?
Thrombectomy and Standard percutaneous coronary intervention
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
7 sitesGermany
Study dates
Mar 2011to Oct 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Germany7 sites

  • Zentralklinik Bad Berka

    Bad Berka

  • Unfallkrankenhaus Berlin

    Berlin

  • Klinikum Frankfurt/Oder

    Frankfurt (Oder)

  • University of Saarland, Campus Homburg/Saar

    Homburg

  • University of Leipzig

    Leipzig

  • Institut für Herzinfarktforschung

    Ludwigshafen

  • University of Tübingen

    Tübingen

Other trials in Germany

About this study

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.

Being tested
Thrombectomy, Standard percutaneous coronary intervention
Keywords
Non-ST-elevation myocardial infarction, thrombectomy, magnetic resonance imaging, microvascular obstruction
Medical subject headings
Non-ST Elevated Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ThrombectomyProcedure or surgery

    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 interventionProcedure or surgery

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

Study groups in NCT01612312
Study groupRoleWhat they receive
ThrombectomyActive comparatorNot described
Receives: Procedure: Thrombectomy
Standard percutaneous coronary interventionOtherIn the standard percutaneous coronary intervention (PCI) group, patients will be treated by conventional PCI according to local practice without thrombectomy.
Receives: Procedure: Standard percutaneous coronary intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: CMR performed within day 1 to 4 after randomization

Secondary outcomes (9)

  1. Infarct size assessed by cardiac magnetic resonance imaging (CMR)

    Measured: CMR performed within day 1 to 4 after randomization

  2. Myocardial salvage assessed by cardiac magnetic resonance imaging (CMR)

    Measured: CMR performed within day 1 to 4 after randomization

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

    Measured: CMR performed within day 1 to 4 after randomization

  4. Thrombolysis in Myocardial Infarction (TIMI)-flow post-PCI

    Measured: Immediately after percutaneous coronary intervention

  5. Myocardial blush grade

    Measured: Immediately after percutaneous coronary intervention

  6. Troponin T

    Measured: 24 and 48 hours after randomization

  7. Combined clinical endpoint

    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.

    Measured: Follow-up performed at 6, 12 and approximately 60 months after randomization

  8. Assessment of quality of life

    Measured: 6, 12 and approximately 60 months after randomization

  9. Stroke and bleeding

    Measured: Participants will be followed for the duration of hospital stay (an expected average of 5 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2012 (estimated)
  2. Study startMar 2011
  3. Primary completionJun 2013
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01612312
Sponsor's protocol ID
070-11-07032011
Status last verified
May 2017
First submitted
30 May 2012
Last updated
2 May 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 37046343

  • 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.

    PubMed 36268539

  • 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.

    PubMed 35851282

  • 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.

    PubMed 33083869

  • 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.

    PubMed 32873121

  • 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.

    PubMed 32335515

  • 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.

    PubMed 32030497

  • 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.

    PubMed 31329854

  • 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.

    PubMed 31278521

  • 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.

    PubMed 25212646

  • 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.

    PubMed 23782681

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Thrombectomy and Standard percutaneous coronary intervention in people with Non-ST-elevation Myocardial Infarction, run by University of Leipzig at 7 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Extent of late microvascular obstruction assessed by cardiac magnetic resonance imaging (CMR) (time frame: CMR performed within day 1 to 4 after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01612312, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2017.

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