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

Non-ST-elevation Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01612312
• Other study ID #: 070-11-07032011
• Status: Completed
• Phase: Phase 4
• First received: May 30, 2012
• Last updated: May 1, 2017
• Start date: March 2011
• Est. completion date: October 2016

Study information

• Verified date: May 2017
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: October 2016
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Non-ST-elevation Myocardial Infarction
• Thrombosis

Intervention

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.

Locations

Country	Name	City	State
Germany	Zentralklinik Bad Berka	Bad Berka
Germany	Unfallkrankenhaus Berlin	Berlin
Germany	Klinikum Frankfurt/Oder	Frankfurt/Oder
Germany	University of Saarland, Campus Homburg/Saar	Homburg
Germany	University of Leipzig	Leipzig
Germany	Institut für Herzinfarktforschung	Ludwigshafen
Germany	University of Tübingen	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extent of late microvascular obstruction assessed by cardiac magnetic resonance imaging (CMR)		CMR performed within day 1 to 4 after randomization
Secondary	Infarct size assessed by cardiac magnetic resonance imaging (CMR)		CMR performed within day 1 to 4 after randomization
Secondary	Myocardial salvage assessed by cardiac magnetic resonance imaging (CMR)		CMR performed within day 1 to 4 after randomization
Secondary	Left ventricular ejection fraction assessed by cardiac magnetic resonance imaging (CMR)		CMR performed within day 1 to 4 after randomization
Secondary	Thrombolysis in Myocardial Infarction (TIMI)-flow post-PCI		Immediately after percutaneous coronary intervention
Secondary	Myocardial blush grade		Immediately after percutaneous coronary intervention
Secondary	Troponin T		24 and 48 hours after randomization
Secondary	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.	Follow-up performed at 6, 12 and approximately 60 months after randomization
Secondary	Assessment of quality of life		6, 12 and approximately 60 months after randomization
Secondary	Stroke and bleeding		Participants will be followed for the duration of hospital stay (an expected average of 5 days)