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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Leipzig
Sponsor:
Information provided by (Responsible Party):
Holger Thiele, University of Leipzig
ClinicalTrials.gov Identifier:
NCT01612312
First received: May 30, 2012
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Non-ST-elevation Myocardial Infarction
Procedure: Thrombectomy
Procedure: Standard percutaneous coronary intervention
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Thrombus Aspiration in ThrOmbus Containing culpRiT Lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI)

Resource links provided by NLM:


Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • Extent of late microvascular obstruction assessed by cardiac magnetic resonance imaging (CMR) [ Time Frame: CMR performed within day 1 to 4 after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Infarct size assessed by cardiac magnetic resonance imaging (CMR) [ Time Frame: CMR performed within day 1 to 4 after randomization ] [ Designated as safety issue: No ]
  • Myocardial salvage assessed by cardiac magnetic resonance imaging (CMR) [ Time Frame: CMR performed within day 1 to 4 after randomization ] [ Designated as safety issue: No ]
  • Left ventricular ejection fraction assessed by cardiac magnetic resonance imaging (CMR) [ Time Frame: CMR performed within day 1 to 4 after randomization ] [ Designated as safety issue: No ]
  • Thrombolysis in Myocardial Infarction (TIMI)-flow post-PCI [ Time Frame: Immediately after percutaneous coronary intervention ] [ Designated as safety issue: No ]
  • Myocardial blush grade [ Time Frame: Immediately after percutaneous coronary intervention ] [ Designated as safety issue: No ]
  • Troponin T [ Time Frame: 24 and 48 hours after randomization ] [ Designated as safety issue: No ]
  • Combined clinical endpoint [ Time Frame: Follow-up performed at 6 and 12 months after randomization ] [ Designated as safety issue: No ]
    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.

  • Assessment of quality of life [ Time Frame: 6 and 12 months after randomization ] [ Designated as safety issue: No ]
  • Stroke and bleeding [ Time Frame: Participants will be followed for the duration of hospital stay (an expected average of 5 days) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: March 2011
Estimated Study Completion Date: October 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Thrombectomy Procedure: Thrombectomy
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 intervention
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
In the standard percutaneous coronary intervention (PCI) group, patients will be treated by conventional PCI according to local practice without thrombectomy.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01612312

Contacts
Contact: Holger Thiele, MD + 49 341 865 1427 thielh@medizin.uni-leipzig.de

Locations
Germany
Zentralklinik Bad Berka Completed
Bad Berka, Germany
Unfallkrankenhaus Berlin Recruiting
Berlin, Germany
Contact: Leonard Bruch, MD         
Principal Investigator: Leonard Bruch, MD         
Klinikum Frankfurt/Oder Recruiting
Frankfurt/Oder, Germany
Contact: Oliver Gunkel, MD         
Principal Investigator: Oliver Gunkel, MD         
University of Saarland, Campus Homburg/Saar Completed
Homburg, Germany
University of Leipzig Completed
Leipzig, Germany
Institut für Herzinfarktforschung Completed
Ludwigshafen, Germany
University of Tübingen Completed
Tübingen, Germany
Sponsors and Collaborators
University of Leipzig
Investigators
Principal Investigator: Holger Thiele, MD Heart Center Leipzig, University of Leipzig, Germany
  More Information

No publications provided by University of Leipzig

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Holger Thiele, Co-Director, Department of Internal Medicine/Cardiology, Heart Center Leipzig, University of Leipzig, Germany, University of Leipzig
ClinicalTrials.gov Identifier: NCT01612312     History of Changes
Other Study ID Numbers: 070-11-07032011
Study First Received: May 30, 2012
Last Updated: August 19, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Leipzig:
Non-ST-elevation myocardial infarction
thrombectomy
magnetic resonance imaging
microvascular obstruction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014