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Polish-Italian-Hungarian RAndomized ThrombEctomy Trial
This study is currently recruiting participants.
Verified by Jagiellonian University, January 2007
Sponsored by: Jagiellonian University
Information provided by: Jagiellonian University
ClinicalTrials.gov Identifier: NCT00377650
  Purpose

Aim Primary percutaneous coronary intervention efficacy improvement by DIVER CE thrombectomy system leading to thrombus reduction.

Study design:

Multicenter, prospective, opened, randomized.

Primary endpoints:

ST resolution >70% 60 minutes after PCI

Secondary endpoints:

Thrombectomy system efficacy/passing trough lesion with thrombus reduction according do TIMI thrombus scale ≥ 1 TIMI 3 flow after PCI MBG 3 CMR – infarct size, measurement of left ventricular end-diastolic EDV and end-systolic volumes ESV and ejection fraction (EF) ECHO: measurement of left ventricular end-diastolic EDV and end-systolic volumes ESV, ejection fraction (EF) and wall motion score index (WMSI) Major cardiac events /cardiac death, reMI, rePCI (TVR, TLR, non infarct involved vessel) or CABG/ 6 month follow up Rate of composite angiographic adverse events including: distal embolisation, transient no-reflow or slow flow, final TIMI <3, need of bail out GpIIb/IIIa inhibitors or adenosine or nitroprosside, final thrombus score >1


Condition Intervention Phase
Myocardial Infarction
 Device: Percutaneous thrombectomy
 Phase IV

MedlinePlus related topics: Heart Attack
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Polish-Italian-Hungarian RAndomized ThrombEctomy Trial. PIHRATE Trial.

Further study details as provided by Jagiellonian University:

Primary Outcome Measures:
  • ST resolution >70% 60 minutes after PCI

Secondary Outcome Measures:
  • Thrombectomy system efficacy/passing trough lesion with thrombus reduction according do TIMI thrombus scale ≥ 1
  • TIMI 3 flow after PCI
  • MBG 3
  • CMR – infarct size, measurement of left ventricular end-diastolic EDV and end-systolic volumes ESV and ejection fraction (EF)
  • ECHO: measurement of left ventricular end-diastolic EDV and end-systolic volumes ESV, ejection fraction (EF) and wall motion score index (WMSI)
  • Major cardiac events /cardiac death, reMI, rePCI (TVR, TLR, non infarct involved vessel) or CABG/ 6 month follow up
  • Rate of composite angiographic adverse events including: distal embolisation, transient no-reflow or slow flow, final TIMI <3, need of bail out GpIIb/IIIa inhibitors or adenosine or nitroprosside, final thrombus score >1

Estimated Enrollment: 200
Study Start Date: September 2005
Estimated Study Completion Date: December 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ST elevation acute myocardial infarction within 6 hours since pain onset, with 2 mm ST segment elevation in two lead
  • Minimum 3 mm ST segment elevation in one leads
  • Vessel reference diameter > 2.5 mm
  • When vessel reference diameter ≥ 4,0 mm than additional distal protection device (filter) is needed during stent implantation

Exclusion Criteria:

  • Contraindications to PCI (contrast allergy, no possibility to stent implantation) ASA, thienopirydins or GP IIb/IIIa inhibitors
  • Active bleeding or coagutopathy
  • Prior CABG or PCI
  • Known ejection fraction EF <35%
  • Cardiogenic shock /SBP < 90 mmHg, IABP and/or catheloamins usage/
  • LBBB, pacemaker rhythm
  • Severe calcifications
  • Previous Myocardial infarction
  • Stroke history
  • Patient directly after reanimation
  • Known thrombocytopenia- platelets < 100 000
  • Pregnancy
  • Cancer disease
  • No future patient cooperation expected
  • Patient’s taking part in the other clinical trials
  • Fibrynolisis directly administered before PCI
  • Renal insufficiency (creatynine > 220 µmol/ml), hemodialysis
  • Contraindications to PCI (contrast allergy, no possibility to stent implantation) ASA, thienopirydins or GP IIb/IIIa inhibitors
  • Active bleeding or coagutopathy
  • Prior CABG or PCI
  • Known ejection fraction EF <35%
  • Cardiogenic shock /SBP < 90 mmHg, IABP and/or catheloamins usage/
  • LBBB, pacemaker rhythm
  • Severe calcifications
  • Previous Myocardial infarction
  • Stroke history
  • Patient directly after reanimation
  • Known thrombocytopenia- platelets < 100 000
  • Pregnancy
  • Cancer disease
  • No future patient cooperation expected
  • Patient’s taking part in the other clinical trials
  • Fibrynolisis directly administered before PCI
  • Renal insufficiency (creatynine > 220 µmol/ml), hemodialysis
  • Liver insufficiency
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00377650

Contacts
Contact: Dariusz Dudek, MD 124247181 ext +48 mcdudek@cyf-kr.edu.pl

Locations
Hungary
Institute, Medical School of University Pecs Recruiting
Pecs, Hungary
Contact: Ivan Horvath, MD         ivan.g.horvath@aok.pte.hu    
Principal Investigator: Ivan Horvath, MD            
Italy
Institute of Cardiology, Catholic University Recruiting
Rome, Italy
Contact: Francesco Burzotta, MD         f.burzotta@rm.unicatt.it    
Principal Investigator: Francesco Burzotta, MD            
Cardiology Department Hospital Villascassi Recruiting
Genova, Italy
Contact: Paolo Rubartelli, MD         paolo.rubartelli@villascassi.it    
Principal Investigator: Paolo Rubartelli, MD            
Poland
Zaklad Hemodynamiki i Angiokardiohrafii IK CMUJ Recruiting
Krakow, Poland, 31-501
Contact: Waldemar A Mielecki, MD     124247181 ext +48     wmielecki@su.krakow.pl    
Principal Investigator: Dariusz Dudek, MD            
Sub-Investigator: Waldemar A Mielecki, MD            
Szpital Wojewódzki w Przemyślu Recruiting
Przemyśl, Poland
Contact: Andrzej Wiśniewski, MD     166775000 ext +48        
Principal Investigator: Andrzej Wiśniewski, MD            
Górnośląskie Centrum Medyczne Recruiting
Katowice, Poland
Contact: Andrzej Ochala, Md         aochala@poczta.onet.pl    
Principal Investigator: Andrzej Ochała, MD            
Slaskie Centrum Chorob Serca Recruiting
Zabrze, Poland
Contact: Mariusz Gasior, MD         m.gasior@sccs.pl    
Principal Investigator: Mariusz Gasior, MD            
Oddział Kardiologii Inwazyjnej, Elektroterapii i Angiologii NZOZ Recruiting
Nowy Sacz, Poland
Contact: Renata Korpak-Wysocka, MD     184407487 ext +48        
Principal Investigator: Renata Korpak-Wysocka, MD            
Sub-Investigator: Dawid Giszterowicz, MD            
Instytut Kardiologii im.Prymasa Tysiaclecia Sefana Kardynala Wyszynskiego Recruiting
Warszawa, Poland, 04-628
Contact: Adam Witkowski, MD         witkowski@hbz.pl    
Principal Investigator: Adam Witkowski, MD            
Sponsors and Collaborators
Jagiellonian University
Investigators
Principal Investigator: Dariusz Dudek, MD Jagiellonian University Medical College
  More Information

Study ID Numbers: JagiellonianU
Study First Received: September 14, 2006
Last Updated: January 16, 2007
ClinicalTrials.gov Identifier: NCT00377650  
Health Authority: Poland: Ministry of Health

Study placed in the following topic categories:
Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases
 Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009



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