Coronary Artery DiseaseLOTUSNCT02634086
Long-term Outcome of Triple-vessel Coronary Artery Disease Underwent Three Different Strategies (LOTUS)
An observational study of Coronary Artery Disease and Coronary Stenosis, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
The study is to determine the long-term outcome of patients with coronary triple vessels disease (TVD) in the real world of China, by three different treatment strategies: percutaneous coronary intervention (PCI), Coronary artery bypass graft (CABG) or optimal medication therapy (OMT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Stenosis, Myocardial Ischemia
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- Apr 2004to Dec 2018
- 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: Between April 2004 and April 2018 in Fuwai Hospital, Beijing, China, consecutive patients with angiography confirmed triple-vessel coronary disease.
Who may be able to join
- Subject has coronary angiography confirmed triple-vessel disease.
- Subject is ≥ 18 years of age at the time of inclusion.
- Subject is willing to comply with all protocol-required follow-up evaluation (patient will be followed during 1 month after hospital to assess any complications and clinical status).
Who cannot join
- Subject is participating in another investigational clinical trial that may cause non-compliance with the protocol or confound data interpretation.
- Female subjects with a positive quantitative or qualitative pregnancy test, in accordance with hospital policy.
- Subjects with no way contact by telephone for follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital
Beijing, Beijing Municipality, 100037
Lei Song, MD, drsongfw@gmail.com
Lei Song, MD, lsongqd@yahoo.com
About this study
The study is to determine the long-term outcome of patients with coronary triple vessels disease (TVD) in the real world of China, by three different treatment strategies: percutaneous coronary intervention (PCI), Coronary artery bypass graft (CABG) or optimal medication therapy (OMT).
Read the detailed description
About 10,000 participants will be enrolled into this retrospective study. Study coordinators will include both men and women over the age of 18 who had angiographic proved triple-vessel disease in a 15 years long-term. Detailed procedural data will be obtained by the study coordinator and local principal investigator. These data will be entered into the electronic data capture system. Participants will have telephone follow-up interviews conducted by the centralized follow-up center at Fuwai Hospital.
- Keywords
- Coronary artery disease, Percutaneous coronary intervention, Coronary artery bypass graft, Medication therapy
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous coronary intervention | Patients with triple-vessel coronary artery disease underwent percutaneous coronary intervention. | |
| Coronary artery bypass graft | Patients with triple-vessel coronary artery disease underwent coronary artery bypass graft. | |
| Optimal medication therapy | Patients with triple-vessel coronary artery disease underwent optimal medication therapy only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
The mortality due to any cause
Measured: Through study completion, an average of 5 year
Secondary outcomes (4)
Major adverse cardiac and cerebrovascular event
The incidence rate of major adverse cardiac and cerebrovascular event (MACCE), which is a combination of all-cause death, myocardial infarction, stroke and repeat revascularization
Measured: Through study completion, an average of 5 year
Myocardial infarction
The Incidence rate of myocardial infarction, including ST elevation myocardial infarction and non-ST elevation myocardial infarction
Measured: Through study completion, an average of 5 year
Stroke
The incidence rate of stroke, including cerebral infarction and hemorrhage
Measured: Through study completion, an average of 5 year
Repeat revascularization
The incidence rate of repeat revascularization, including target vessel revascularization and non-target vessel revascularization
Measured: Through study completion, an average of 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startApr 2004
- Primary completionApr 2016 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Song, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Lei Song, MD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634086
- Sponsor's protocol ID
- 2010CB732601
- Acronym
- LOTUS
- Status last verified
- Dec 2015
- First submitted
- 14 Dec 2015
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Xu JJ, Zhang Y, Jiang L, Tian J, Song L, Gao Z, Feng XX, Zhao XY, Zhao YY, Wang D, Sun K, Xu LJ, Liu R, Gao RL, Xu B, Song L, Yuan JQ. Comparison of Long-term Outcomes in Patients with Premature Triple-vessel Coronary Disease Undergoing Three Different Treatment Strategies: A Prospective Cohort Study. Chin Med J (Engl). 2018 Jan 5;131(1):1-9. doi: 10.4103/0366-6999.221273.
PubMed 29271373
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcome of Triple-vessel Coronary Artery Disease Underwent Three Different Strategies (LOTUS)
- ClinicalTrials.gov ID
- NCT02634086
- Acronym / sponsor ID
- LOTUS / 2010CB732601
- Keywords
- Coronary artery disease, Percutaneous coronary intervention, Coronary artery bypass graft, Medication therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 17 Dec 2015 (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.
The study is to determine the long-term outcome of patients with coronary triple vessels disease (TVD) in the real world of China, by three different treatment strategies: percutaneous coronary intervention (PCI), Coronary artery bypass graft (CABG) or optimal medication therapy (OMT).
Detailed description
About 10,000 participants will be enrolled into this retrospective study. Study coordinators will include both men and women over the age of 18 who had angiographic proved triple-vessel disease in a 15 years long-term. Detailed procedural data will be obtained by the study coordinator and local principal investigator. These data will be entered into the electronic data capture system. Participants will have telephone follow-up interviews conducted by the centralized follow-up center at Fuwai Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Percutaneous coronary intervention | – | –Patients with triple-vessel coronary artery disease underwent percutaneous coronary intervention. |
| Coronary artery bypass graft | – | –Patients with triple-vessel coronary artery disease underwent coronary artery bypass graft. |
| Optimal medication therapy | – | –Patients with triple-vessel coronary artery disease underwent optimal medication therapy only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Between April 2004 and April 2018 in Fuwai Hospital, Beijing, China, consecutive patients with angiography confirmed triple-vessel coronary disease.
Key inclusion criteria (3 listed)
- Subject has coronary angiography confirmed triple-vessel disease.
- Subject is ≥ 18 years of age at the time of inclusion.
- Subject is willing to comply with all protocol-required follow-up evaluation (patient will be followed during 1 month after hospital to assess any complications and clinical status).
Key exclusion criteria (3 listed)
- Subject is participating in another investigational clinical trial that may cause non-compliance with the protocol or confound data interpretation.
- Female subjects with a positive quantitative or qualitative pregnancy test, in accordance with hospital policy.
- Subjects with no way contact by telephone for follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality
Time frame: Through study completion, an average of 5 year
The mortality due to any cause
4 secondary outcomes
Major adverse cardiac and cerebrovascular event
Time frame: Through study completion, an average of 5 year
Myocardial infarction
Time frame: Through study completion, an average of 5 year
Stroke
Time frame: Through study completion, an average of 5 year
Repeat revascularization
Time frame: Through study completion, an average of 5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
- Derived from this study: PubMed 29271373Xu JJ, Zhang Y, Jiang L, Tian J, Song L, Gao Z, Feng XX, Zhao XY, Zhao YY, Wang D, Sun K, Xu LJ, Liu R, Gao RL, Xu B, Song L, Yuan JQ. Comparison of Long-term Outcomes in Patients with Premature Triple-vessel Coronary Disease Undergoing Three Different Treatment Strategies: A Prospective Cohort Study. Chin Med J (Engl). 2018 Jan 5;131(1):1-9. doi: 10.4103/0366-6999.221273.
- Individual participant dataSharing planned: Undecided
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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.
Lei Song, MD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Coronary Stenosis, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
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 3 inclusion and 3 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 18 Dec 2015. 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 China. 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?
Contact Lei Song, MD (+86-13910968125, drsongfw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: Through study completion, an average of 5 year). 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 NCT02634086, which also lists 1 linked publication.
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 18 Dec 2015.