Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
150 participants
INTERVENTIONAL
2007-01-31
2008-12-31
Brief Summary
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Detailed Description
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In early nineties the procedures of percutaneous angioplasty in patients with depressed left ventricular function were connected with comparable to CABG risk of death (5-10%).
The intensive progress of percutaneous procedures contributed PCI is competitive method of revasularization to CABG. Our knowledge about the efficacy of above mentioned methods in patients with ischemic heart failure is scarce until now. It was proved, that patients with viable myocardium assessed in dobutamine stress echocardiography or MRI benefit mostly from myocardial revascularization. Repeat revascularization during follow up occurred more frequently in patients after PCI, so that introduction of coronary stents, especially drug eluting stents (DES) could significantly improve the clinical outcome after PCI procedures. The administration of antiplatelet drugs (IIb/IIIa platelet receptor inhibitors) have considerably improved the short and long-term results of PCI so that it is interesting if they could have beneficial effect on clinical outcome of patients with ischemic heart failure. In the field of cardiac surgery the method of left ventricle reconstruction in patients with ischemic cardiomyopathy (STICH Trial) seems to be promising.
Therefore, the comparison of innovative methods of percutaneous and surgical revascularization may influence current medical standards concerning patients with ischemic heart disease.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Percutaneous Coronary Intervention
Coronary Artery Bypass Grafting
Eligibility Criteria
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Inclusion Criteria
* left ventricle ejection fraction \<40%
* coronary artery lesions suitable for percutaneous or surgical myocardial revascularisation
* evidence for viability of the myocardium
* written inform consent for the study
Exclusion Criteria
* acute myocardial infarct with ST elevation within 30 days
* concomitant congenital heart disease
* mitral regurgitation required surgical intervention
* history of bleeding diathesis, coagulopathy or abnormal bleeding within the previous 30 days.
* major surgery within the previous 6 weeks
* stroke or transient ischemic attack (TIA) within the previous 6 weeks
* history of hemorrhagic stroke
* uncontrolled hypertension
* chronic renal insufficiency with creatinine \>2.0 mg/dl
* platelet count \<100.000/mm3
* hematocrit \<30%
* PT \>1,2 times control
* positive pregnancy test
* any disease that may shorten the life expectancy of the patient
* the patient is currently participating in another research study
19 Years
90 Years
ALL
No
Sponsors
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Ministry of Science and Higher Education, Poland
OTHER_GOV
Principal Investigators
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Pawel E Buszman, Prof
Role: STUDY_DIRECTOR
3-rd Division of Cardiology, University School of Silesia, Poland
Michal Tendera, Prof
Role: STUDY_CHAIR
3-rd Division of Cardiology, University School of Silesia, Poland
Andrzej Bochenek, Prof
Role: PRINCIPAL_INVESTIGATOR
1-st Division of Cardiosurgery, University School of Silesia, Poland
Robert J Gil, Prof
Role: PRINCIPAL_INVESTIGATOR
Invasive Cardiology Department, Central Clinic Hospital, Warsaw, Poland
Piotr Ponikowski, Prof
Role: PRINCIPAL_INVESTIGATOR
Heart Disease Department, Military Clinic Hospital, Wroclaw, Poland
Locations
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University School of Silesia, 1-st Department of Cardiosurgery
Katowice, Silesian Voivodeship, Poland
University School of Silesia, 3-rd Department of Cardiology, Coronary Care Unit
Katowice, Silesian Voivodeship, Poland
Central Clinic Hospital
Warsaw, , Poland
Military Clinic Hospital
Wroclaw, , Poland
Countries
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Central Contacts
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References
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Serruys PW, Ong AT, van Herwerden LA, Sousa JE, Jatene A, Bonnier JJ, Schonberger JP, Buller N, Bonser R, Disco C, Backx B, Hugenholtz PG, Firth BG, Unger F. Five-year outcomes after coronary stenting versus bypass surgery for the treatment of multivessel disease: the final analysis of the Arterial Revascularization Therapies Study (ARTS) randomized trial. J Am Coll Cardiol. 2005 Aug 16;46(4):575-81. doi: 10.1016/j.jacc.2004.12.082.
Scholz KH, Dubois-Rande JL, Urban P, Morice MC, Loisance D, Smalling RW, Figulla HR. Clinical experience with the percutaneous hemopump during high-risk coronary angioplasty. Am J Cardiol. 1998 Nov 1;82(9):1107-10, A6. doi: 10.1016/s0002-9149(98)00566-9.
Shawl FA, Quyyumi AA, Bajaj S, Hoff SB, Dougherty KG. Percutaneous cardiopulmonary bypass-supported coronary angioplasty in patients with unstable angina pectoris or myocardial infarction and a left ventricular ejection fraction < or = 25%. Am J Cardiol. 1996 Jan 1;77(1):14-9. doi: 10.1016/s0002-9149(97)89127-8.
Van Belle E, Blouard P, McFadden EP, Lablanche JM, Bauters C, Bertrand ME. Effects of stenting of recent or chronic coronary occlusions on late vessel patency and left ventricular function. Am J Cardiol. 1997 Nov 1;80(9):1150-4. doi: 10.1016/s0002-9149(97)00631-0.
Bax JJ, Poldermans D, Elhendy A, Cornel JH, Boersma E, Rambaldi R, Roelandt JR, Fioretti PM. Improvement of left ventricular ejection fraction, heart failure symptoms and prognosis after revascularization in patients with chronic coronary artery disease and viable myocardium detected by dobutamine stress echocardiography. J Am Coll Cardiol. 1999 Jul;34(1):163-9. doi: 10.1016/s0735-1097(99)00157-6.
Other Identifiers
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0213/P01/2006/31
Identifier Type: -
Identifier Source: org_study_id