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Polish-Italian-Hungarian RAndomized ThrombEctomy Trial

Primary Purpose

Myocardial Infarction

Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Percutaneous thrombectomy
Sponsored by
Jagiellonian University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute, Medical School of University PecsRecruiting
  • Cardiology Department Hospital VillascassiRecruiting
  • Institute of Cardiology, Catholic UniversityRecruiting
  • Górnośląskie Centrum MedyczneRecruiting
  • Zaklad Hemodynamiki i Angiokardiohrafii IK CMUJRecruiting
  • Oddział Kardiologii Inwazyjnej, Elektroterapii i Angiologii NZOZRecruiting
  • Szpital Wojewódzki w PrzemyśluRecruiting
  • Instytut Kardiologii im.Prymasa Tysiaclecia Sefana Kardynala WyszynskiegoRecruiting
  • Slaskie Centrum Chorob SercaRecruiting

Outcomes

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

Full Information

First Posted
September 14, 2006
Last Updated
January 16, 2007
Sponsor
Jagiellonian University
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1. Study Identification

Unique Protocol Identification Number
NCT00377650
Brief Title
Polish-Italian-Hungarian RAndomized ThrombEctomy Trial
Official Title
Polish-Italian-Hungarian RAndomized ThrombEctomy Trial. PIHRATE Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Unknown status
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Jagiellonian University

4. Oversight

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Percutaneous thrombectomy
Primary Outcome Measure Information:
Title
ST resolution >70% 60 minutes after PCI
Secondary Outcome Measure Information:
Title
Thrombectomy system efficacy/passing trough lesion with thrombus reduction according do TIMI thrombus scale ≥ 1
Title
TIMI 3 flow after PCI
Title
MBG 3
Title
CMR - infarct size, measurement of left ventricular end-diastolic EDV and end-systolic volumes ESV and ejection fraction (EF)
Title
ECHO: measurement of left ventricular end-diastolic EDV and end-systolic volumes ESV, ejection fraction (EF) and wall motion score index (WMSI)
Title
Major cardiac events /cardiac death, reMI, rePCI (TVR, TLR, non infarct involved vessel) or CABG/ 6 month follow up
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dariusz Dudek, MD
Phone
124247181
Ext
+48
Email
mcdudek@cyf-kr.edu.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dariusz Dudek, MD
Organizational Affiliation
Jagiellonian University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute, Medical School of University Pecs
City
Pecs
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Horvath, MD
Email
ivan.g.horvath@aok.pte.hu
First Name & Middle Initial & Last Name & Degree
Ivan Horvath, MD
Facility Name
Cardiology Department Hospital Villascassi
City
Genova
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Rubartelli, MD
Email
paolo.rubartelli@villascassi.it
First Name & Middle Initial & Last Name & Degree
Paolo Rubartelli, MD
Facility Name
Institute of Cardiology, Catholic University
City
Rome
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Burzotta, MD
Email
f.burzotta@rm.unicatt.it
First Name & Middle Initial & Last Name & Degree
Francesco Burzotta, MD
Facility Name
Górnośląskie Centrum Medyczne
City
Katowice
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrzej Ochala, Md
Email
aochala@poczta.onet.pl
First Name & Middle Initial & Last Name & Degree
Andrzej Ochała, MD
Facility Name
Zaklad Hemodynamiki i Angiokardiohrafii IK CMUJ
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Waldemar A Mielecki, MD
Phone
124247181
Ext
+48
Email
wmielecki@su.krakow.pl
First Name & Middle Initial & Last Name & Degree
Dariusz Dudek, MD
First Name & Middle Initial & Last Name & Degree
Waldemar A Mielecki, MD
Facility Name
Oddział Kardiologii Inwazyjnej, Elektroterapii i Angiologii NZOZ
City
Nowy Sacz
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renata Korpak-Wysocka, MD
Phone
184407487
Ext
+48
First Name & Middle Initial & Last Name & Degree
Renata Korpak-Wysocka, MD
First Name & Middle Initial & Last Name & Degree
Dawid Giszterowicz, MD
Facility Name
Szpital Wojewódzki w Przemyślu
City
Przemyśl
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrzej Wiśniewski, MD
Phone
166775000
Ext
+48
First Name & Middle Initial & Last Name & Degree
Andrzej Wiśniewski, MD
Facility Name
Instytut Kardiologii im.Prymasa Tysiaclecia Sefana Kardynala Wyszynskiego
City
Warszawa
ZIP/Postal Code
04-628
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Witkowski, MD
Email
witkowski@hbz.pl
First Name & Middle Initial & Last Name & Degree
Adam Witkowski, MD
Facility Name
Slaskie Centrum Chorob Serca
City
Zabrze
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariusz Gasior, MD
Email
m.gasior@sccs.pl
First Name & Middle Initial & Last Name & Degree
Mariusz Gasior, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
21095287
Citation
Dudek D, Mielecki W, Burzotta F, Gasior M, Witkowski A, Horvath IG, Legutko J, Ochala A, Rubartelli P, Wojdyla RM, Siudak Z, Buchta P, Pregowski J, Aradi D, Machnik A, Hawranek M, Rakowski T, Dziewierz A, Zmudka K. Thrombus aspiration followed by direct stenting: a novel strategy of primary percutaneous coronary intervention in ST-segment elevation myocardial infarction. Results of the Polish-Italian-Hungarian RAndomized ThrombEctomy Trial (PIHRATE Trial). Am Heart J. 2010 Nov;160(5):966-72. doi: 10.1016/j.ahj.2010.07.024.
Results Reference
derived

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Polish-Italian-Hungarian RAndomized ThrombEctomy Trial

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