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Inflammatory Biomarkers Predict Pulmonary Outcomes in Coronary Artery Bypass Grafting (CABG BALF)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01366469
First Posted: June 6, 2011
Last Update Posted: February 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Omar Lattouf, Emory University
  Purpose

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.


Condition
Coronary Artery Disease Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Inflammatory Biomarkers Predict Pulmonary Outcomes in Coronary Artery Bypass Grafting

Resource links provided by NLM:


Further study details as provided by Omar Lattouf, Emory University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Secondary outcome measure [ Time Frame: 30 Day Follow-up ]
    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.


Biospecimen Retention:   Samples With DNA
BAL fluid, Serum

Enrollment: 10
Study Start Date: April 2011
Study Completion Date: December 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients from Cardiothoracic surgery service
Criteria

Inclusion Criteria:

  • Undergoing elective CABG
  • Current diagnosis of COPD
  • Ability to provide signed informed consent to participate
  • > 18 years of age

Exclusion Criteria:

  • Concomitant valve surgery
  • Urgent or emergent coronary surgery
  • Current steroid therapy
  • Active smoker and/or positive urine co-nicotine
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01366469


Locations
United States, Georgia
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Omar M Lattouf, MD Emory University
  More Information

Responsible Party: Omar Lattouf, Professor of Surgery, Emory University
ClinicalTrials.gov Identifier: NCT01366469     History of Changes
Other Study ID Numbers: IRB00046469
CABG BALF ( Other Identifier: Other )
First Submitted: June 2, 2011
First Posted: June 6, 2011
Last Update Posted: February 19, 2014
Last Verified: February 2014

Keywords provided by Omar Lattouf, Emory University:
coronary artery bypass grafting
coronary artery disease
chronic obstructive pulmonary disease

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases