Inflammatory Biomarkers Predict Pulmonary Outcomes in Coronary Artery Bypass Grafting

Coronary Artery Disease Clinical Trial

— CABG BALF  

Official title:

Inflammatory Biomarkers Predict Pulmonary Outcomes in Coronary Artery Bypass Grafting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366469
• Other study ID #: IRB00046469
• Secondary ID: CABG BALF
• Status: Completed
• Phase: N/A
• First received: June 2, 2011
• Last updated: February 18, 2014
• Start date: April 2011
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Coronary Artery Disease
• Coronary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Myocardial Ischemia
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United States	Emory University Hospital Midtown	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During Hospitalization	Yes
Secondary	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.	30 Day Follow-up	Yes