Chronic Obstructive Pulmonary DiseaseNCT02392065
Chronic Obstructive Pulmonary Disease as a Predictor of Mortality in Cardiac Surgery
An observational study of Chronic Obstructive Pulmonary Disease and Cardiac Surgery, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
To estimate prevalence of chronic obstructive pulmonary disease (COPD) in cardiac surgery population and establish links between COPD status, as assessed through pulmonary functional tests, and 2-year mortality Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Cardiac Surgery
- How many people
- 1,100 participants
- Where
- 1 siteRussia
- Study dates
- Mar 2015to Mar 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients scheduled for coronary artery bypass surgery during one year will be screened and approached
Who may be able to join
- written informed consent, planned elective coronary artery bypass graft surgery
Who cannot join
- contraindications to pulmonary functional tests, emergency surgery, recent or ongoing myocardial infarction, angina
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Novosibirsk Research Institute of Circulation Pathology
Novosibirsk, 630055
Dmitry Ponomarev, MD, MSc, +79232339205, d_ponomarev@meshalkin.ru
About this study
Official title: Chronic Obstructive Pulmonary Disease as a Predictor of 2-year Mortality in Patients Undergoing Coronary Artery Bypass Graft Surgery
To estimate prevalence of chronic obstructive pulmonary disease (COPD) in cardiac surgery population and establish links between COPD status, as assessed through pulmonary functional tests, and 2-year mortality
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Vladimir Lomivorotov, MD, PhD, Study director, Novosibisrk Research Institute of Circulation Pathology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392065
- Sponsor's protocol ID
- COPD14_2014
- Status last verified
- Mar 2016
- First submitted
- 12 Mar 2015
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Obstructive Pulmonary Disease as a Predictor of 2-year Mortality in Patients Undergoing Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT02392065
- Acronym / sponsor ID
- COPD14_2014
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Mar 2015
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 18 Mar 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.
To estimate prevalence of chronic obstructive pulmonary disease (COPD) in cardiac surgery population and establish links between COPD status, as assessed through pulmonary functional tests, and 2-year mortality
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients scheduled for coronary artery bypass surgery during one year will be screened and approached
Key inclusion criteria (1 listed)
- written informed consent, planned elective coronary artery bypass graft surgery
Key exclusion criteria (1 listed)
- contraindications to pulmonary functional tests, emergency surgery, recent or ongoing myocardial infarction, angina
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: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
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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.
Vladimir Lomivorotov, MD, PhD study director
Novosibisrk Research Institute of Circulation Pathology
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 Chronic Obstructive Pulmonary Disease and Cardiac Surgery, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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 1 inclusion and 1 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 16 Mar 2016. 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 Russia. 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 Dmitry Ponomarev, MD, MSc (+79232339205, d_ponomarev@meshalkin.ru), 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: Two 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 Mar 2016.