Ischemic Heart DiseaseNCT00123981
The Danish On-pump, Off-pump Randomization Study (DOORS)
A study testing Off-Pump Coronary Artery Bypass Grafting in people with Ischemic Heart Disease, run by Kim Houlind at 1 site in Denmark.
Trial summary
Background: Coronary artery bypass grafting (CABG) can be performed either with or without the use of cardiopulmonary bypass (CPB) to obtain myocardial re-vascularisation. The investigators hypothesize that CABG without the use of CPB may reduce the risk of perioperative death, stroke, myocardial infarction and other… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Off-Pump Coronary Artery Bypass Grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2005to Jan 2011
- Phase
- Interventional
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age seventy years or above
- Admitted for first time coronary artery bypass operation
Who cannot join
- Given information cannot be understood
- Aortic crossclamping not safe due to calcification
- Preoperative cardiac conditions demanding cardiopulmonary bypass
- Re-do cardiac surgery
- Patients requiring operation within the same day after conference
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Cardiothoracic and Vascular Surgery, Skejby Sygehus, Aarhus University Hospital
Aarhus, Aarhus, 8200
About this study
Official title: The Impact of Avoiding Cardiopulmonary By-pass During Coronary Artery Bypass Surgery for Ischemic Heart Disease in Elderly Patients: The Danish On-pump, Off-pump Randomization Study (DOORS)
Background: Coronary artery bypass grafting (CABG) can be performed either with or without the use of cardiopulmonary bypass (CPB) to obtain myocardial re-vascularisation. The investigators hypothesize that CABG without the use of CPB may reduce the risk of perioperative death, stroke, myocardial infarction and other serious complications.
The aim of the present study is to compare the incidence of complications and the clinical efficacy of CABG with and without the use of CPB in elderly patients.
Read the detailed description
Conventional coronary artery bypass grafting (CCABG) using cardiopulmonary bypass has for decades been applied to obtain myocardial re-vascularisation and, hence, improved quality of life and survival. It does, however, bear a risk of death, stroke, myocardial infarction and other serious complications.
During recent years, an equivalent operation performed on the beating heart without cardiopulmonary bypass (off-pump coronary artery bypass grafting, OPCAB) has gained popularity helped by the advent of mechanical stabilization devices and improved surgical techniques. Observational studies suggest that this technique is associated with a lower incidence of stroke, per operative arrhythmias and even mortality than conventional CCABG. This is especially the case in elderly patients and patients with significant co-morbidity.
Only few randomised, controlled trials have been conducted and most of these included mainly or only low-risk, relatively young patients. These studies have documented the safety and efficacy of OPCAB compared with CCABG, but none of the trials has had the statistical strength to determine whether the rate of serious complications is lower after OPCAB operations. One recent study found graft patency to be significantly lower after OPCAB than after CCABG operations.
The investigators find that there is a need of a larger scale randomised trial to compare the results of CCABG and OPCAB operations, especially in elderly patients. This patient group is poorly represented in earlier randomised trials, whereas observational studies and theoretical considerations imply that they may benefit the most from avoiding cardiopulmonary bypass.
Aims: Primarily, to compare the incidence of death, stroke and myocardial infarction after CCABG and OPCAB procedures in a population of elderly patients. Furthermore, to compare quality of life and graft patency, and cost- effectiveness after CCABG and OPCAB.
- Conditions
- Ischemic Heart Disease
- Being tested
- Off-Pump Coronary Artery Bypass Grafting
- Keywords
- Off-pump Coronary Artery By-pass Grafting, Randomization, stroke, myocardial infarction, mortality, graft patency, quality of life
- Medical subject headings
- Myocardial Ischemia, Stroke, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Off-Pump Coronary Artery Bypass GraftingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| CCABG | Active comparator | Coronary artery bypass surgery using cardiopulmonary bypass Receives: Procedure: Off-Pump Coronary Artery Bypass Grafting |
| OPCAB | Experimental | Coronary artery bypass surgery NOT using cardiopulmonary bypass Receives: Procedure: Off-Pump Coronary Artery Bypass Grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
A combined endpoint of death + stroke + myocardial infarction within 30 days from operation
Measured: 30 days
Secondary outcomes (6)
A combined endpoint of death + stroke + myocardial infarction during follow-up
Measured: 3 years
Patency of bypass grafts assessed by coronary angiography 6 months after the operation
Measured: 6 months
Total mortality and cardiac mortality during follow-up
Measured: 3 years
Need of new intervention for cardiac angina during follow-up
Measured: 3 years
Quality of life assessed by MOS SF-36 and EuroQol questionnaires 6 months and 3 years after the operation
Measured: 6 months and 3 years
Total hospital costs and costs of public care provided 6 months and 3 years after the operation and difference in costs per quality adjusted life year
Measured: 6 months and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2005 (estimated)
- Study startJan 2005
- Primary completionNov 2008
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kim Houlind
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kim Houlind, Odense University Hospital
- Investigators
- Kim C Houlind, MD, PhD, Principal investigator, Aarhus University HospitalPoul E Mortensen, MD, Study chair, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123981
- Sponsor's protocol ID
- DTS-0001
- Status last verified
- Nov 2013
- First submitted
- 25 Jul 2005
- Last updated
- 6 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Houlind KC, Kjeldsen BJ, Terp KA, Madsen SN, Schmidt TA, Holme SJ, Mortensen PE. [Coronary artery bypass surgery without the use of a heart-lunch machine]. Ugeskr Laeger. 2005 May 9;167(19):2037-41. No abstract available. Danish.
PubMed 15960455Houlind K, Fenger-Gron M, Holme SJ, Kjeldsen BJ, Madsen SN, Rasmussen BS, Jepsen MH, Ravkilde J, Aaroe J, Hansen PR, Hansen HS, Mortensen PE; DOORS Study Group. Graft patency after off-pump coronary artery bypass surgery is inferior even with identical heparinization protocols: results from the Danish On-pump Versus Off-pump Randomization Study (DOORS). J Thorac Cardiovasc Surg. 2014 Nov;148(5):1812-1819.e2. doi: 10.1016/j.jtcvs.2014.02.024. Epub 2014 Feb 8.
PubMed 24613160Houlind K, Kjeldsen BJ, Madsen SN, Rasmussen BS, Holme SJ, Nielsen PH, Mortensen PE; DOORS Study Group. On-pump versus off-pump coronary artery bypass surgery in elderly patients: results from the Danish on-pump versus off-pump randomization study. Circulation. 2012 May 22;125(20):2431-9. doi: 10.1161/CIRCULATIONAHA.111.052571. Epub 2012 Apr 20.
PubMed 22523305Houlind K, Kjeldsen BJ, Madsen SN, Rasmussen BS, Holme SJ, Schmidt TA, Haahr PE, Mortensen PE; DOORS study group. The impact of avoiding cardiopulmonary by-pass during coronary artery bypass surgery in elderly patients: the Danish On-pump Off-pump Randomisation Study (DOORS). Trials. 2009 Jul 4;10:47. doi: 10.1186/1745-6215-10-47.
PubMed 19575814
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Avoiding Cardiopulmonary By-pass During Coronary Artery Bypass Surgery for Ischemic Heart Disease in Elderly Patients: The Danish On-pump, Off-pump Randomization Study (DOORS)
- ClinicalTrials.gov ID
- NCT00123981
- Acronym / sponsor ID
- DTS-0001
- Conditions
- Ischemic Heart Disease
- Keywords
- Off-pump Coronary Artery By-pass Grafting, Randomization, stroke, myocardial infarction, mortality, graft patency, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Kim HoulindUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Nov 2008 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 26 Jul 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.
Background: Coronary artery bypass grafting (CABG) can be performed either with or without the use of cardiopulmonary bypass (CPB) to obtain myocardial re-vascularisation. The investigators hypothesize that CABG without the use of CPB may reduce the risk of perioperative death, stroke, myocardial infarction and other serious complications.
The aim of the present study is to compare the incidence of complications and the clinical efficacy of CABG with and without the use of CPB in elderly patients.
Detailed description
Conventional coronary artery bypass grafting (CCABG) using cardiopulmonary bypass has for decades been applied to obtain myocardial re-vascularisation and, hence, improved quality of life and survival. It does, however, bear a risk of death, stroke, myocardial infarction and other serious complications.
During recent years, an equivalent operation performed on the beating heart without cardiopulmonary bypass (off-pump coronary artery bypass grafting, OPCAB) has gained popularity helped by the advent of mechanical stabilization devices and improved surgical techniques. Observational studies suggest that this technique is associated with a lower incidence of stroke, per operative arrhythmias and even mortality than conventional CCABG. This is especially the case in elderly patients and patients with significant co-morbidity.
Only few randomised, controlled trials have been conducted and most of these included mainly or only low-risk, relatively young patients. These studies have documented the safety and efficacy of OPCAB compared with CCABG, but none of the trials has had the statistical strength to determine whether the rate of serious complications is lower after OPCAB operations. One recent study found graft patency to be significantly lower after OPCAB than after CCABG operations.
The investigators find that there is a need of a larger scale randomised trial to compare the results of CCABG and OPCAB operations, especially in elderly patients. This patient group is poorly represented in earlier randomised trials, whereas observational studies and theoretical considerations imply that they may benefit the most from avoiding cardiopulmonary bypass.
Aims: Primarily, to compare the incidence of death, stroke and myocardial infarction after CCABG and OPCAB procedures in a population of elderly patients. Furthermore, to compare quality of life and graft patency, and cost- effectiveness after CCABG and OPCAB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCABG | Active comparator | Procedure: Off-Pump Coronary Artery Bypass GraftingCoronary artery bypass surgery using cardiopulmonary bypass |
| OPCAB | Experimental | Procedure: Off-Pump Coronary Artery Bypass GraftingCoronary artery bypass surgery NOT using cardiopulmonary bypass |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age seventy years or above
- Admitted for first time coronary artery bypass operation
Key exclusion criteria (5 listed)
- Given information cannot be understood
- Aortic crossclamping not safe due to calcification
- Preoperative cardiac conditions demanding cardiopulmonary bypass
- Re-do cardiac surgery
- Patients requiring operation within the same day after conference
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 |
|---|---|---|
| Off-Pump Coronary Artery Bypass Grafting | Procedure or surgery | CCABG, OPCAB |
Primary outcome
A combined endpoint of death + stroke + myocardial infarction within 30 days from operation
Time frame: 30 days
6 secondary outcomes
A combined endpoint of death + stroke + myocardial infarction during follow-up
Time frame: 3 years
Patency of bypass grafts assessed by coronary angiography 6 months after the operation
Time frame: 6 months
Total mortality and cardiac mortality during follow-up
Time frame: 3 years
Need of new intervention for cardiac angina during follow-up
Time frame: 3 years
Quality of life assessed by MOS SF-36 and EuroQol questionnaires 6 months and 3 years after the operation
Time frame: 6 months and 3 years
Total hospital costs and costs of public care provided 6 months and 3 years after the operation and difference in costs per quality adjusted life year
Time frame: 6 months and 3 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 6 Nov 2013.
- Background: PubMed 15960455Houlind KC, Kjeldsen BJ, Terp KA, Madsen SN, Schmidt TA, Holme SJ, Mortensen PE. [Coronary artery bypass surgery without the use of a heart-lunch machine]. Ugeskr Laeger. 2005 May 9;167(19):2037-41. No abstract available. Danish.
- Derived from this study: PubMed 24613160Houlind K, Fenger-Gron M, Holme SJ, Kjeldsen BJ, Madsen SN, Rasmussen BS, Jepsen MH, Ravkilde J, Aaroe J, Hansen PR, Hansen HS, Mortensen PE; DOORS Study Group. Graft patency after off-pump coronary artery bypass surgery is inferior even with identical heparinization protocols: results from the Danish On-pump Versus Off-pump Randomization Study (DOORS). J Thorac Cardiovasc Surg. 2014 Nov;148(5):1812-1819.e2. doi: 10.1016/j.jtcvs.2014.02.024. Epub 2014 Feb 8.
- Derived from this study: PubMed 22523305Houlind K, Kjeldsen BJ, Madsen SN, Rasmussen BS, Holme SJ, Nielsen PH, Mortensen PE; DOORS Study Group. On-pump versus off-pump coronary artery bypass surgery in elderly patients: results from the Danish on-pump versus off-pump randomization study. Circulation. 2012 May 22;125(20):2431-9. doi: 10.1161/CIRCULATIONAHA.111.052571. Epub 2012 Apr 20.
- Derived from this study: PubMed 19575814Houlind K, Kjeldsen BJ, Madsen SN, Rasmussen BS, Holme SJ, Schmidt TA, Haahr PE, Mortensen PE; DOORS study group. The impact of avoiding cardiopulmonary by-pass during coronary artery bypass surgery in elderly patients: the Danish On-pump Off-pump Randomisation Study (DOORS). Trials. 2009 Jul 4;10:47. doi: 10.1186/1745-6215-10-47.
- home page of the Danish Heart FoundationLink provided by the sponsor.
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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.
Kim C Houlind, MD, PhD principal investigator
Aarhus University Hospital
Poul E Mortensen, MD study chair
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Off-Pump Coronary Artery Bypass Grafting in people with Ischemic Heart Disease, run by Kim Houlind at 1 site in Denmark.
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 5 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 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
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?
A combined endpoint of death + stroke + myocardial infarction within 30 days from operation (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00123981, which also lists 4 linked publications.
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 6 Nov 2013.