Status:
COMPLETED
Analyzing Lung Tissue in People With and Without Chronic Obstructive Pulmonary Disease Who Are Undergoing Lung Transplantation
Lead Sponsor:
Washington University School of Medicine
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
18+ years
Brief Summary
Chronic obstructive pulmonary disease (COPD) is a long-term lung disease. People with COPD have difficulty breathing because of lung damage. However, for many people with COPD, while some areas of the...
Detailed Description
COPD is a common lung disease and is the fourth most common cause of death in the United States. Symptoms include coughing, excess mucus production, shortness of breath,and wheezing. There is no cure ...
Eligibility Criteria
Inclusion
- Age equal to or greater than 18 years
- Ability to read and write in English
- Able to participate in the informed consent process
- Listed at Barnes-Jewish Hospital for lung transplantation for COPD (with alpha-1-antitrypsin deficiency \[A1ATD\] or non-1ATD)
- Global Initiative for Chronic Obstructive Lung Disease (GOLD) class IV COPD
- Acceptable chest computed tomography (CT) exam completed at Barnes-Jewish Hospital in the 3 years before study entry
Exclusion
- Pregnant
- Prisoner
- Vulnerable populations
- Coexisting active chronic inflammatory or collagen vascular disease, immunodeficiency of any kind, non-cutaneous malignancy (melanoma is an exclusion), or previous organ transplant
- Coexisting (other than COPD / emphysema / chronic bronchitis)significant pulmonary parenchymal disorder (e.g., pulmonary fibrosis)
- Exclusion Criteria for 3-Helium MRI Procedure:
- Inability to perform 10 to 15 second breath hold for 3-Helium MRI scan.
- Contraindications to MRI (including pacemaker, metal implants, other devices affected by the magnet).
- Contraindications to 3-Helium MRI (including significant anemia \[hemoglobin less than or equal to 12 g/dL, with the last testing within 1 month of the MRI scan\] or marked oxyhemoglobin desaturation at rest when breathing room air \[requiring more than 4 liters per minute of supplemental oxygen to keep saturation of oxygen (SaO2) at least 90%\]).However, patients deemed to be low risk kfor complications of cerebrovascular disease, cardiovascular disease, heart dysrhythmias, and seizures through the thorough lung transplant evaluation will be eligible for testing. Since most of the patients with these contraindications to 3-Helium MRI will be ineligible for lung transplantation, we expect few patients to have such contraindications to testing.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00756522
Start Date
October 1 2007
End Date
May 1 2016
Last Update
June 18 2018
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110