Coronary Artery DiseaseCABG BALFNCT01366469
Inflammatory Biomarkers Predict Pulmonary Outcomes in Coronary Artery Bypass Grafting
An observational study of Coronary Artery Disease and Chronic Obstructive Pulmonary Disease, run by Emory University at 1 site in United States.
Trial summary
The primary objective of this pilot study is to identify and quantify inflammatory and genetic markers from bronchoalveolar lavage fluid (BALF) and serum in patients with a history of chronic obstructive pulmonary disease (COPD) undergoing elective coronary revascularization (CABG) to determine the risk of developing… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Coronary Artery Disease, Chronic Obstructive Pulmonary Disease
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Dec 2013
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients from Cardiothoracic surgery service
Who may be able to join
- Undergoing elective CABG
- Current diagnosis of COPD
- Ability to provide signed informed consent to participate
- > 18 years of age
Who cannot join
- Concomitant valve surgery
- Urgent or emergent coronary surgery
- Current steroid therapy
- Active smoker and/or positive urine co-nicotine
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Hospital Midtown
Atlanta, Georgia, 30308
About this study
The primary objective of this pilot study is to identify and quantify inflammatory and genetic markers from bronchoalveolar lavage fluid (BALF) and serum in patients with a history of chronic obstructive pulmonary disease (COPD) undergoing elective coronary revascularization (CABG) to determine the risk of developing post operative respiratory failure. To achieve this objective, this proposal outlines the following specific aims:
Aim #1. To identify from BALF and serum, the change in inflammatory and genetic markers in patients with a history of COPD undergoing CABG. BALF and serum samples will be obtained at the time of intubation immediately prior to surgery and again upon skin closure immediately after the surgical procedure.
Read more
Aim #2. To determine the extent to which inflammatory and/or genetic markers correlate with post-operative pulmonary complications defined as prolonged mechanical ventilation (> 24 hours), pneumonia, and/or tracheostomy.
Aim #3. To inform the development and implementation of a large pivotal trial which may impact clinical decision-making during the initial pre-operative outpatient assessment of COPD patients undergoing CABG.
- Keywords
- coronary artery bypass grafting, coronary artery disease, chronic obstructive pulmonary disease
- Medical subject headings
- Coronary Artery Disease, Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure
The identification of specific inflammatory and genetic markers associated with post-operative pulmonary complications in this population of elective CABG patients with a history of COPD.
Measured: During Hospitalization
Secondary outcomes (1)
Secondary outcome measure
Post-operative pulmonary complications: prolonged mechanical ventilation (defined as >24 hours), atelectasis, pneumonia, exacerbation of COPD and tracheostomy. All-cause mortality will also be assessed.
Measured: 30 Day Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2012
- Study completionDec 2013
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 Emory UniversityThe 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
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Lattouf, Emory University
- Investigators
- Omar M Lattouf, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366469
- Sponsor's protocol ID
- IRB00046469
- Other IDs
- CABG BALF
- Acronym
- CABG BALF
- Status last verified
- Feb 2014
- First submitted
- 2 Jun 2011
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Biomarkers Predict Pulmonary Outcomes in Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT01366469
- Acronym / sponsor ID
- CABG BALF / IRB00046469
- Keywords
- coronary artery bypass grafting, coronary artery disease, chronic obstructive pulmonary disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Jun 2011 (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 primary objective of this pilot study is to identify and quantify inflammatory and genetic markers from bronchoalveolar lavage fluid (BALF) and serum in patients with a history of chronic obstructive pulmonary disease (COPD) undergoing elective coronary revascularization (CABG) to determine the risk of developing post operative respiratory failure. To achieve this objective, this proposal outlines the following specific aims:
Aim #1. To identify from BALF and serum, the change in inflammatory and genetic markers in patients with a history of COPD undergoing CABG. BALF and serum samples will be obtained at the time of intubation immediately prior to surgery and again upon skin closure immediately after the surgical procedure.
Aim #2. To determine the extent to which inflammatory and/or genetic markers correlate with post-operative pulmonary complications defined as prolonged mechanical ventilation (> 24 hours), pneumonia, and/or tracheostomy.
Aim #3. To inform the development and implementation of a large pivotal trial which may impact clinical decision-making during the initial pre-operative outpatient assessment of COPD patients undergoing CABG.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients from Cardiothoracic surgery service
Key inclusion criteria (4 listed)
- Undergoing elective CABG
- Current diagnosis of COPD
- Ability to provide signed informed consent to participate
- > 18 years of age
Key exclusion criteria (4 listed)
- Concomitant valve surgery
- Urgent or emergent coronary surgery
- Current steroid therapy
- Active smoker and/or positive urine co-nicotine
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
Primary outcome measure
Time frame: During Hospitalization
The identification of specific inflammatory and genetic markers associated with post-operative pulmonary complications in this population of elective CABG patients with a history of COPD.
1 secondary outcome
Secondary outcome measure
Time frame: 30 Day Follow-up
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 19 Feb 2014.
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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.
Omar M Lattouf, MD principal investigator
Emory University
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 Chronic Obstructive Pulmonary Disease, run by Emory University at 1 site in United States.
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 4 inclusion and 4 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 19 Feb 2014. 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 United States. 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?
Primary outcome measure (time frame: During Hospitalization). 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 19 Feb 2014.