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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Omar Lattouf, Emory University
ClinicalTrials.gov Identifier:
NCT01366469
First received: June 2, 2011
Last updated: February 18, 2014
Last verified: February 2014
  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 Emory University:

Primary Outcome Measures:
  • Primary outcome measure [ Time Frame: During Hospitalization ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Omar Lattouf, Professor of Surgery, Emory University
ClinicalTrials.gov Identifier: NCT01366469     History of Changes
Other Study ID Numbers: IRB00046469, CABG BALF
Study First Received: June 2, 2011
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 19, 2014