NCT00616369|Completed
Identification of Genetic Markers for Cardiopulmonary Diseases (Genotype)
Genotype
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Genotype
Sponsor study identifier
observational
255
1 country
1
Study Start
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2015
Actual (reported)Study Completion
January 2015
Actual (reported)This study is designed to investigate whether an association exists between certain genes/protein levels and the development of various cardiopulmonary diseases. It is hoped that this project will provide valuable insight into the understanding of these diseases.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
February 5, 2008
Actual (reported)February 15, 2008
Actual (reported)January 2015
Actual (reported)January 2015
Actual (reported)Changes in NYHA WHO Functional Class,right and left heart catheterization measurements, echocardiograms, 6MWT, laboratory values, electrocardiograms, x-ray's, MRI's, CT Scans, Pulmonary Function Tests, and Ventilation Perfusion Scans will be assessed.
10 years
I: For those patients who have had blood samples drawn as a result of participating in current protocol, Identification of Genetic Markers for Primary Pulmonary Hypertension study (X980515002), we would like to use their previously obtained blood and continue to draw samples (12mL; less than 3 tablespoons) ONLY if they change disease therapies. For those patients who participated in Pulmonary Arterial Hypertension (PAH) Database study (X030403017), these participants will also sign a consent form to participant in this new trial. We would like to use the previously obtained data from the X030403017 in part with this study. As for the X980515002 expired patients, we would like to use the previously obtained data ONLY in part for this study that was collected as a result of the X980515002 study.
II: Group 2: After signing a consent form, these participants will have a 12mL (less than 3 teaspoons) blood sample drawn at baseline, at 3-4 month, at 6-8 month, at 12 month, and at 24 month visits. With each disease therapy change, the blood draws (12mL samples) will begin again at baseline and continue through the 3-4, 6-8, 12, and 24 month visits.
Participants with the diagnosis of any of the previously listed Cardiopulmonary Diseases who are ≥15 years of age will be approached and offered the opportunity to participate in this study.
University of Alabama @ Birmingham
Birmingham, Alabama, 35294, United States
The following genetic tests will be performed on these specimens: Endothelin1, Endothelin receptors A\&B, Prostaglandin, Prostaglandin receptors, CytochromeP450, NPR, A, B and C, Transforming Growth Factor (B), Pai-1 HindIII, Toll-like receptor4, Pai-1 4g5g, Xho-1, P22, Tissue Plasminogin Activators, Urokinase Plasminogen Activators, Fibrinogen, Nitric Oxide Synthase, BMPRs, SMADs, VEGFs, FGFs, Rho Kinase, Elastins, Angiopoietin, PDE5, Serotonin receptor, Angiotensin, Alk 1, and Cell Culture (DNA immortalization) There is a possibility that other genetic testing could arise as the study progresses. In this case, the IRB would be notified prior to testing.
Robert C Bourge, MD
University of Alabama at Birmingham Division of Medicine
255 participants (actual enrollment reported by the registry).
First Submitted
February 5, 2008
First Posted
February 15, 2008
Study Start
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
Cardiovascular Biorepository
Contact the study team to confirm eligibility.
Primary Completion
January 2015
Actual (reported)Study Completion
January 2015
Actual (reported)Last Updated
January 11, 2016
Record last verified: 2016-01
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Source: ClinicalTrials.gov.
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