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Sponsored by: |
University of Alabama at Birmingham |
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Information provided by: | University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00616369 |
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.
Condition |
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Cardiovascular Diseases |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Identification of Genetic Markers for Cardiopulmonary Diseases |
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.
Estimated Enrollment: | 1000 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | January 2018 |
Estimated Primary Completion Date: | January 2018 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
I: For those patients who have had blood samples drawn as a result of participating in Dr. Benza's 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 Dr. Benza's 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. |
2
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. |
There are two main groups of participants in this trial:
Group 1: Patients that are enrolled in either or both of Dr. Benza's previous studies: X980515002 study (Identification of Genetic Markers for Primary Pulmonary Hypertension) and or X030403017 study (Pulmonary Arterial Hypertension (PAH) Database)
Group 2: Participants with the diagnosis of any of the previously listed Cardiopulmonary Diseases who are ≥15 years of age
Group 1: For those patients who have had blood samples drawn as a result of participating in Dr. Benza's 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. With each disease therapy change, blood will be drawn at baseline, at 3-4 month, at 6-8 month, at 12 month, and at 24 month visits. These current X980515002 participants WILL sign a consent form to participate in this new trial. 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.
For those patients who participated in Dr. Benza's 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. With each disease therapy change, a 12mL (less than 3 teaspoons) blood sample will be drawn at baseline, at 3-4 month, at 6-8 month, at 12 month, and at 24 month visits. As for the X030403017 expired patients, we would like to use the previously obtained data in part for this study that was collected as a result of the X030403017 study.
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.
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
Contact: Raymond Benza, MD | 205-934-8710 | rbenza@uab.edu |
United States, Alabama | |
University of Alabama @ Birmingham | Recruiting |
Birmingham, Alabama, United States, 35294 | |
Contact: Raymond Benza, MD 205-934-8710 rbenza@uab.edu | |
Sub-Investigator: Robert C Bourge, MD | |
Sub-Investigator: Barry K Rayburn, MD | |
Sub-Investigator: Jose A Tallaj, MD | |
Sub-Investigator: Salpy V Pamboukian, MD |
Principal Investigator: | Raymond Benza, MD | University of Alabama at Birmingham Division of Medicine |
Responsible Party: | University of Alabama @Birmingham (UAB) ( Raymond Benza, MD ) |
Study ID Numbers: | X070116004 |
Study First Received: | February 5, 2008 |
Last Updated: | February 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00616369 History of Changes |
Health Authority: | United States: Institutional Review Board |
pulmonary hypertension hypertension cardiomyopathy arrhythmias |
Heart Diseases Hypertension, Pulmonary Pulmonary Heart Disease |
Cardiomyopathies Arrhythmias, Cardiac Hypertension |
Heart Diseases Pulmonary Heart Disease Cardiovascular Diseases |