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Polish-Italian-Hungarian RAndomized ThrombEctomy Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Jagiellonian University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Jagiellonian University
ClinicalTrials.gov Identifier:
NCT00377650
First received: September 14, 2006
Last updated: January 16, 2007
Last verified: January 2007
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Polish-Italian-Hungarian RAndomized ThrombEctomy Trial. PIHRATE Trial.

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

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
Cardiology Department Hospital Villascassi Recruiting
Genova, Italy
Contact: Paolo Rubartelli, MD         paolo.rubartelli@villascassi.it    
Principal Investigator: Paolo Rubartelli, MD            
Institute of Cardiology, Catholic University Recruiting
Rome, Italy
Contact: Francesco Burzotta, MD         f.burzotta@rm.unicatt.it    
Principal Investigator: Francesco Burzotta, MD            
Poland
Górnośląskie Centrum Medyczne Recruiting
Katowice, Poland
Contact: Andrzej Ochala, Md         aochala@poczta.onet.pl    
Principal Investigator: Andrzej Ochała, MD            
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            
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            
Szpital Wojewódzki w Przemyślu Recruiting
Przemyśl, Poland
Contact: Andrzej Wiśniewski, MD     166775000 ext +48        
Principal Investigator: Andrzej Wiśniewski, 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            
Slaskie Centrum Chorob Serca Recruiting
Zabrze, Poland
Contact: Mariusz Gasior, MD         m.gasior@sccs.pl    
Principal Investigator: Mariusz Gasior, MD            
Sponsors and Collaborators
Jagiellonian University
Investigators
Principal Investigator: Dariusz Dudek, MD Jagiellonian University Medical College
  More Information

No publications provided by Jagiellonian University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

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

ClinicalTrials.gov processed this record on May 22, 2013