Ischemic Heart DiseasePRAGUE 6+NCT00606372
On-Pump vs. Off-Pump CABG in High-Risk Patients (EuroSCORE 6+)
An observational study of Ischemic Heart Disease and Post-Operative Complications, run by Charles University, Czech Republic at 2 sites in Czechia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease, Post-Operative Complications
- What is being tested?
- OPCAB - the off-pump coronary artery bypass
- Type of treatment
- Surgery or procedure
- How many people
- 220 participants
- Where
- 2 sitesCzechia
- Study dates
- Jun 2006to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People indicated for surgical myocardial revascularisation with high surgical risk
Who may be able to join
- stable form of ischemic heart disease
- unstable angina pectoris
- acute myocardial infarction
- additive EuroSCORE 6 and more
- informed approval of the patient
Who cannot join
- significant heart valve disease, requesting surgery
- aortic aneurysm requesting surgery
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites
Kralovske Vinohrady University Hospital
Prague, 10034
2nd Surgical Dpt. of 1st Faculty of Medicine of Charles University, Prague
Prague, 11000
About this study
Official title: Aortocoronary Bypasses in High-Risk Patients (EuroSCORE 6+) With or Without Use of the Cardio-Pulmonary Bypass.
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).
- Being tested
- OPCAB - the off-pump coronary artery bypass
- Keywords
- Off-pump, OPCAB, EuroSCORE, high-risk patients, Quality of life, Validity of EuroSCORE
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPCAB - the off-pump coronary artery bypassProcedure or surgery
surgical myocardial revascularisation without use of cardio-pulmonary bypass, using stabilising devices on beating heart
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with ischemic heart disease, with EuroSCORE 6 additive points and more, operated with use of the cardio-pulmonary bypass | |
| 2 | Patients with ischemic heart disease, with EuroSCORE 6 additive points and more, operated without use of the cardio-pulmonary bypass Receives: Procedure: OPCAB - the off-pump coronary artery bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
death, heart stroke, brain stroke, renal failure, early reoperation
Measured: 30 days
heart stroke, brain stroke, death, renal failure, early reoperation
Measured: 30 days and 365 days
Secondary outcomes (1)
length of in-hospital stay, blood losses, number of blood-transfusion, new appeared atrial fibrillation, 1-year mortality, quality of life-angina classified by CCS in 1-year follow up, length of mechanical ventilation
Measured: 30 days and 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2008 (estimated)
- Study startJun 2006
- Primary completionDec 2008
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Investigators
- Zbynek Straka, 1, Principal investigator, Charles University, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606372
- Sponsor's protocol ID
- 240376
- Acronym
- PRAGUE 6+
- Status last verified
- Jan 2008
- First submitted
- 22 Jan 2008
- Last updated
- 4 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortocoronary Bypasses in High-Risk Patients (EuroSCORE 6+) With or Without Use of the Cardio-Pulmonary Bypass.
- ClinicalTrials.gov ID
- NCT00606372
- Acronym / sponsor ID
- PRAGUE 6+ / 240376
- Keywords
- Off-pump, OPCAB, EuroSCORE, high-risk patients, Quality of life, Validity of EuroSCORE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2009 (estimated)
- First posted
- 4 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with ischemic heart disease, with EuroSCORE 6 additive points and more, operated with use of the cardio-pulmonary bypass |
| 2 | – | Procedure: OPCAB - the off-pump coronary artery bypassPatients with ischemic heart disease, with EuroSCORE 6 additive points and more, operated without use of the cardio-pulmonary bypass |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People indicated for surgical myocardial revascularisation with high surgical risk
Key inclusion criteria (5 listed)
- stable form of ischemic heart disease
- unstable angina pectoris
- acute myocardial infarction
- additive EuroSCORE 6 and more
- informed approval of the patient
Key exclusion criteria (2 listed)
- significant heart valve disease, requesting surgery
- aortic aneurysm requesting surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPCAB - the off-pump coronary artery bypasssurgical myocardial revascularisation without use of cardio-pulmonary bypass, using stabilising devices on beating heart | Procedure or surgery | 2 |
Primary outcome
death, heart stroke, brain stroke, renal failure, early reoperation
Time frame: 30 days
heart stroke, brain stroke, death, renal failure, early reoperation
Time frame: 30 days and 365 days
1 secondary outcome
length of in-hospital stay, blood losses, number of blood-transfusion, new appeared atrial fibrillation, 1-year mortality, quality of life-angina classified by CCS in 1-year follow up, length of mechanical ventilation
Time frame: 30 days and 365 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zbynek Straka, 1 principal investigator
Charles University, Prague
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease and Post-Operative Complications, run by Charles University, Czech Republic at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death, heart stroke, brain stroke, renal failure, early reoperation (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2008.