Coronary Artery BypassPhase 2NCT00202332
CABG Without the Use of CPB
A Phase 2 study testing Coronary artery bypass in people with Coronary Artery Bypass, run by Melbourne Health.
Trial summary
Comparison of clinical outcomes in patients undergoing coronary bypass surgery using the heart/lung machine as opposed to using off-pump techniques. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Bypass
- What is being tested?
- Coronary artery bypass
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Feb 2001to Feb 2004
- Phase
- Phase 2
- 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 to 85 years
- All sexes
- Adult, Older adult
Who may be able to join
- Exclusion Criteria: Less than 18 years Emergency and salvage operations
- -
Who cannot join
None listed.
About this study
Official title: A Prospective Randomised Study od Coronary Artery Bypass Surgery Without the Use of Cardiopulmonary Bypass
Comparison of clinical outcomes in patients undergoing coronary bypass surgery using the heart/lung machine as opposed to using off-pump techniques.
- Conditions
- Coronary Artery Bypass
- Being tested
- Coronary artery bypass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary artery bypassProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of clinical outcomes for coronary artery bypass graft surgery when performed using cardiopulmonary bypass versus beating heart surgery without cardiopulmonary bypass
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startFeb 2001
- Primary completionFeb 2003
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery BypassStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Melbourne Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Davis, MD, Study chair, Melbourne Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202332
- Sponsor's protocol ID
- 1999.115
- Status last verified
- Jul 2015
- First submitted
- 15 Sep 2005
- Last updated
- 16 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Study od Coronary Artery Bypass Surgery Without the Use of Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT00202332
- Acronym / sponsor ID
- 1999.115
- Conditions
- Coronary Artery Bypass
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Melbourne HealthUniversity, hospital or other
- Study start
- Feb 2001
- Primary completion
- Feb 2003 (actual)
- Study completion
- Feb 2004 (actual)
- First posted
- 20 Sep 2005 (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.
Comparison of clinical outcomes in patients undergoing coronary bypass surgery using the heart/lung machine as opposed to using off-pump techniques.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Exclusion Criteria: Less than 18 years Emergency and salvage operations
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Coronary artery bypass | Procedure or surgery | – |
Primary outcome
Comparison of clinical outcomes for coronary artery bypass graft surgery when performed using cardiopulmonary bypass versus beating heart surgery without cardiopulmonary bypass
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2015.
Related trials for Coronary Artery Bypass
Not yet recruiting
Partial Cardiac Denervation for Preventing Atrial Fibrillation After CABG
Postoperative Atrial Fibrillation, Coronary Artery Disease
Active, not recruiting
Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery
Coronary Artery Bypass Graft (CABG)
Recruiting
Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery
Coronary Artery Disease With Need for Bypass Surgery, Coronary Artery Disease(CAD)
Active, not recruitingPhase 1
Comparison of Analgesic Efficacy Between Ultrasound Guided Serratus Anterior Plane Block or Thoracic Paravertebral Block Versus Intravenous Fentanyl for On-pump Coronary Artery Bypass Graft Surgery
Intra and Post Operative Pain Management, Fast Track Program,(Enhanced Recovery After Surgery (ERAS))
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
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.
Stephen Davis, MD study chair
Melbourne Health
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Coronary artery bypass in people with Coronary Artery Bypass, run by Melbourne Health.
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 2 inclusion and 0 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: finished, as of the sponsor's last update on 16 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of clinical outcomes for coronary artery bypass graft surgery when performed using cardiopulmonary bypass versus beating heart surgery without cardiopulmonary bypass (time frame: 2 years). 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 16 Jul 2015.