Coronary Artery DiseaseNOBLE-LADNCT03538886
Nordic-Baltic Coronary Revascularization Study in Patients With Proximal Left Descending Coronary Artery (LAD) Lesion.
A study testing Coronary artery bypass grafting (CABG) and Percutaneous coronary intervention (PCI) in people with Coronary Artery Disease, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
The Nordic-Baltic Heart Team Initiative for improved long-term coronary artery revascularization outcome compares quality of life and survival after coronary bypass grafting (CABG) vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Coronary artery bypass grafting (CABG) and Percutaneous coronary intervention (PCI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2018to 31 Jul 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart Team decision on treatment
- 1-VD patients with stable coronary artery disease or stabilized unstable angina pectoris/NSTEMI or silent ischemia Proximal LAD (pLAD) stenosis (>90% by visual assessment or FFR <80% The lesion may be treated by both PCI and surgery
Who cannot join
- ST-elevation myocardial infarction within 24 hours. Expected survival <1 year, because of high age or severe cardiac or non-cardiac disease.
- Significant LM disease. Earlier CABG. PCI within 3 months. Significant valvular heart disease. Renal failure on dialysis Earlier disabling stroke Relative or absolute contraindication to dual antiplatelet therapy. Allergy relevant to the study treatments. Age < 18 years. Study required information and consent suboptimal or impossible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Nordic-Baltic Heart Team Initiative for Improved Long-term Coronary Artery Revascularization Outcome in Patients With Proximal Left Descending Coronary Artery (LAD) Lesion. NOBLE LAD
The Nordic-Baltic Heart Team Initiative for improved long-term coronary artery revascularization outcome compares quality of life and survival after coronary bypass grafting (CABG) vs. percutaneous coronary intervention (PCI) in patients with 1-vessel disease and proximal stenosis of the anterior descending artery (LAD/in patients with isolated proximal left descending coronary artery (LAD) lesion
Read the detailed description
It is not clear how operable 1-VD patients with stable or stabilized coronary artery disease involving a pLAD lesion should be treated to optimize long-term survival and quality of life.
According to recent European guidelines, significant pLAD disease may be treated by PCI or by CABG. This recommendation is based on two meta-analyses including 1.210 and 1.952 randomized and non-randomized patients. Generally, the patients were followed for 4-5 years. The analyses reported similar rates of mortality, MI and stroke, but more repeat revascularizations after PCI. Only one study including129 patients provided more than 5-year follow-up. Thus, the there is limited documentation for long-term effect of PCI vs. surgical re-vascularization in pLAD disease.
The American 2014 Guidelines on coronary revascularization recommends CABG for improved survival in patients with solitary proximal LAD stenosis. CABG
The angiographic 90% LIMA patency rate after 1, 2 and 3 decades is well described and suggestive of a survival benefit of surgical revascularization.
Therefore, there is scientific background for an CABG LIMA-to-LAD vs. PCI comparison in 1-VD patients with a pLAD lesion.
Substantiated expectations:
- PCI is superior to bypass operation concerning short-term quality of life.
- Off-pump LIMA-to-LAD is superior to PCI concerning long-term all-cause mortality.
- Long-term (≥10-year) follow-up is essential to evaluate coronary revascularization strategies.
- Outcome may be dependent on lesion complexity, diabetes and gender.
- Conditions
- Coronary Artery Disease
- Being tested
- Coronary artery bypass grafting (CABG), Percutaneous coronary intervention (PCI)
- Keywords
- Coronary revascularization
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary artery bypass grafting (CABG)Procedure or surgery
Revascularization of LAD lesion by CABG
Percutaneous coronary intervention (PCI)Procedure or surgery
Revascularization of LAD lesion by PCI
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous coronary intervention (PCI) | Active comparator | Currently, percutaneous coronary intervention (PCI) using balloon and drug eluting stents is the treatment of choice for treatment of a proximal LAD lesion. Receives: Procedure: Percutaneous coronary intervention (PCI) |
| Coronary artery bypass grafting (CABG) | Experimental | Coronary artery bypass grafting is a well established treatment with documented excellent long-term results for the treatment of proximal LAD lesion. Receives: Procedure: Coronary artery bypass grafting (CABG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Death of any cause
Measured: 10 years
Quality of life
By SF 12 and Seatle Angina Questionaire
Measured: 1 year
MACCE
Major cardiac and cerebral adverse events (myocardial infarction, stroke, revascularization, death)
Measured: 1 year
Secondary outcomes (8)
All-cause death
Death of any cause
Measured: 1, 2, 3, 5 and 10 years
Cardiac death
Death of cardiac disease
Measured: 1, 2, 3, 5 and 10 years
Spontaneous myocardial infarction
Type 1 myocardial infarction
Measured: 1, 2, 3, 5 and 10 years
Procedure related myocardial infarction
Myocardial infarction related to PCI or CABG
Measured: 1, 2, 3, 5 and 10 years
Major stroke, minor stroke and al stroke
Stroke by VARC definition
Measured: 1, 2, 3, 5 and 10 years
Angina
CCS angina class
Measured: 1, 2, 3, 5 and 10 years
Heart failure
NYHA class
Measured: 1, 2, 3, 5 and 10 years
Stent thrombosis
ARC-define stent thrombosis
Measured: 1, 2, 3, 5 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start1 Jun 2018
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Why it stopped: Impossible to involve a sufficient number of centers in the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oulu University Hospital, Region Örebro County, Pauls Stradins Clinical University Hospital
- Responsible party
- Principal investigator, Leif Thuesen, Aalborg University Hospital
- Investigators
- Leif Thuesen, MD, Principal investigator, Department of Cardiology, Aalborg University HospitalJan Jesper Andreasen, Prof, Principal investigator, Department of Cardiothoracic Surgery, Aalborg University HospitalPeter Sogaard, Prof, Study chair, Department of Cardiology, aaalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538886
- Sponsor's protocol ID
- NOBLE-LAD_Protocol version 3
- Acronym
- NOBLE-LAD
- Status last verified
- Apr 2021
- First submitted
- 16 May 2018
- Last updated
- 6 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication of the trial, data will be made available for metaanalyses on request, and after accept by the steering committee.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Nordic-Baltic Heart Team Initiative for Improved Long-term Coronary Artery Revascularization Outcome in Patients With Proximal Left Descending Coronary Artery (LAD) Lesion. NOBLE LAD
- ClinicalTrials.gov ID
- NCT03538886
- Acronym / sponsor ID
- NOBLE-LAD / NOBLE-LAD_Protocol version 3
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary revascularization
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Impossible to involve a sufficient number of centers in the study.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Oulu University Hospital, Region Örebro County, Pauls Stradins Clinical University Hospital
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 29 May 2018 (actual)
- 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.
The Nordic-Baltic Heart Team Initiative for improved long-term coronary artery revascularization outcome compares quality of life and survival after coronary bypass grafting (CABG) vs. percutaneous coronary intervention (PCI) in patients with 1-vessel disease and proximal stenosis of the anterior descending artery (LAD/in patients with isolated proximal left descending coronary artery (LAD) lesion
Detailed description
It is not clear how operable 1-VD patients with stable or stabilized coronary artery disease involving a pLAD lesion should be treated to optimize long-term survival and quality of life.
According to recent European guidelines, significant pLAD disease may be treated by PCI or by CABG. This recommendation is based on two meta-analyses including 1.210 and 1.952 randomized and non-randomized patients. Generally, the patients were followed for 4-5 years. The analyses reported similar rates of mortality, MI and stroke, but more repeat revascularizations after PCI. Only one study including129 patients provided more than 5-year follow-up. Thus, the there is limited documentation for long-term effect of PCI vs. surgical re-vascularization in pLAD disease.
The American 2014 Guidelines on coronary revascularization recommends CABG for improved survival in patients with solitary proximal LAD stenosis. CABG
The angiographic 90% LIMA patency rate after 1, 2 and 3 decades is well described and suggestive of a survival benefit of surgical revascularization.
Therefore, there is scientific background for an CABG LIMA-to-LAD vs. PCI comparison in 1-VD patients with a pLAD lesion.
Substantiated expectations:
- PCI is superior to bypass operation concerning short-term quality of life.
- Off-pump LIMA-to-LAD is superior to PCI concerning long-term all-cause mortality.
- Long-term (≥10-year) follow-up is essential to evaluate coronary revascularization strategies.
- Outcome may be dependent on lesion complexity, diabetes and gender.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Percutaneous coronary intervention (PCI) | Active comparator | Procedure: Percutaneous coronary intervention (PCI)Currently, percutaneous coronary intervention (PCI) using balloon and drug eluting stents is the treatment of choice for treatment of a proximal LAD lesion. |
| Coronary artery bypass grafting (CABG) | Experimental | Procedure: Coronary artery bypass grafting (CABG)Coronary artery bypass grafting is a well established treatment with documented excellent long-term results for the treatment of proximal LAD lesion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Heart Team decision on treatment
- 1-VD patients with stable coronary artery disease or stabilized unstable angina pectoris/NSTEMI or silent ischemia Proximal LAD (pLAD) stenosis (>90% by visual assessment or FFR <80% The lesion may be treated by both PCI and surgery
Key exclusion criteria (2 listed)
- ST-elevation myocardial infarction within 24 hours. Expected survival <1 year, because of high age or severe cardiac or non-cardiac disease.
- Significant LM disease. Earlier CABG. PCI within 3 months. Significant valvular heart disease. Renal failure on dialysis Earlier disabling stroke Relative or absolute contraindication to dual antiplatelet therapy. Allergy relevant to the study treatments. Age < 18 years. Study required information and consent suboptimal or impossible.
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 grafting (CABG)Revascularization of LAD lesion by CABG | Procedure or surgery | Coronary artery bypass grafting (CABG) |
| Percutaneous coronary intervention (PCI)Revascularization of LAD lesion by PCI | Procedure or surgery | Percutaneous coronary intervention (PCI) |
Primary outcome
All-cause mortality
Time frame: 10 years
Death of any cause
Quality of life
Time frame: 1 year
By SF 12 and Seatle Angina Questionaire
MACCE
Time frame: 1 year
Major cardiac and cerebral adverse events (myocardial infarction, stroke, revascularization, death)
8 secondary outcomes
All-cause death
Time frame: 1, 2, 3, 5 and 10 years
Cardiac death
Time frame: 1, 2, 3, 5 and 10 years
Spontaneous myocardial infarction
Time frame: 1, 2, 3, 5 and 10 years
Procedure related myocardial infarction
Time frame: 1, 2, 3, 5 and 10 years
Major stroke, minor stroke and al stroke
Time frame: 1, 2, 3, 5 and 10 years
Angina
Time frame: 1, 2, 3, 5 and 10 years
Heart failure
Time frame: 1, 2, 3, 5 and 10 years
Stent thrombosis
Time frame: 1, 2, 3, 5 and 10 years
Results and safety
The study was stopped early (reason given: Impossible to involve a sufficient number of centers in the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Individual participant dataSharing planned: Yes. After publication of the trial, data will be made available for metaanalyses on request, and after accept by the steering committee.
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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.
Leif Thuesen, MD principal investigator
Department of Cardiology, Aalborg University Hospital
Jan Jesper Andreasen, Prof principal investigator
Department of Cardiothoracic Surgery, Aalborg University Hospital
Peter Sogaard, Prof study chair
Department of Cardiology, aaalborg 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 Coronary artery bypass grafting (CABG) and Percutaneous coronary intervention (PCI) in people with Coronary Artery Disease, run by Aalborg University Hospital 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 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: stopped early, as of the sponsor's last update on 6 Apr 2021. 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 was stopped early (reason given: Impossible to involve a sufficient number of centers in the 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?
All-cause mortality (time frame: 10 years). The study lists 3 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 6 Apr 2021.