On-Pump vs. Off-Pump CABG in High-Risk Patients (EuroSCORE 6+)

NCT ID: NCT00606372

Last Updated: 2008-02-04

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Study Completion Date

2009-12-31

Brief Summary

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Previous studies comparing on-pump and off-pump operating strategy did only partially demonstrate benefits of the off-pump myocardial revascularisation.In primary end-points (MI, death, renal failure, and so on) there was no significant difference, but in secondary end-points we observed benefits resulting for patients. We would like to show the benefit of the method without extracorporeal circulation in patients with higher and hight operation risk, coming from EuroSCORE classification system (6 points and more).

Detailed Description

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Conditions

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Ischemic Heart Disease Post-Operative Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients with ischemic heart disease, with EuroSCORE 6 additive points and more, operated with use of the cardio-pulmonary bypass

No interventions assigned to this group

2

Patients with ischemic heart disease, with EuroSCORE 6 additive points and more, operated without use of the cardio-pulmonary bypass

OPCAB - the off-pump coronary artery bypass

Intervention Type PROCEDURE

surgical myocardial revascularisation without use of cardio-pulmonary bypass, using stabilising devices on beating heart

Interventions

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OPCAB - the off-pump coronary artery bypass

surgical myocardial revascularisation without use of cardio-pulmonary bypass, using stabilising devices on beating heart

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* stable form of ischemic heart disease
* unstable angina pectoris
* acute myocardial infarction
* additive EuroSCORE 6 and more
* informed approval of the patient

Exclusion Criteria

* significant heart valve disease, requesting surgery
* aortic aneurysm requesting surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charles University, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Kralovske Vinohrady University Hospital

Principal Investigators

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Zbynek Straka, 1

Role: PRINCIPAL_INVESTIGATOR

Charles University, Prague

Locations

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Kralovske Vinohrady University Hospital

Prague, , Czechia

Site Status

2nd Surgical Dpt. of 1st Faculty of Medicine of Charles University, Prague

Prague, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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240376

Identifier Type: -

Identifier Source: org_study_id

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