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Polish-Italian-Hungarian RAndomized ThrombEctomy Trial

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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
  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.

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   (Adult, Senior)
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
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: NCT00377650

Locations
Hungary
Institute, Medical School of University Pecs
Pecs, Hungary
Italy
Cardiology Department Hospital Villascassi
Genova, Italy
Institute of Cardiology, Catholic University
Rome, Italy
Poland
Górnośląskie Centrum Medyczne
Katowice, Poland
Zaklad Hemodynamiki i Angiokardiohrafii IK CMUJ
Krakow, Poland, 31-501
Oddział Kardiologii Inwazyjnej, Elektroterapii i Angiologii NZOZ
Nowy Sacz, Poland
Szpital Wojewódzki w Przemyślu
Przemyśl, Poland
Instytut Kardiologii im.Prymasa Tysiaclecia Sefana Kardynala Wyszynskiego
Warszawa, Poland, 04-628
Slaskie Centrum Chorob Serca
Zabrze, Poland
Sponsors and Collaborators
Jagiellonian University
Investigators
Principal Investigator: Dariusz Dudek, MD Jagiellonian University Medical College
  More Information

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 December 09, 2016