Identification of Genetic Markers for Cardiopulmonary Diseases (Genotype)
| Tracking Information | |||||
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| First Received Date ICMJE | February 5, 2008 | ||||
| Last Updated Date | June 22, 2012 | ||||
| Start Date ICMJE | January 2008 | ||||
| Estimated Primary Completion Date | January 2018 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. [ Time Frame: 10 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Information learned may serve to develop new methods of predicting response to therapy in various cardiopulmonary diseases to improve therapy in the future. [ Time Frame: 10 years ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00616369 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Identification of Genetic Markers for Cardiopulmonary Diseases (Genotype) | ||||
| Official Title ICMJE | Identification of Genetic Markers for Cardiopulmonary Diseases | ||||
| Brief Summary | 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. |
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| Detailed Description | There are two main groups of participants in this trial: Group 1: Patients that are enrolled in either or both of 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 the 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 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: 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. |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | 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. |
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| Condition ICMJE | Cardiovascular Diseases | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 1000 | ||||
| Estimated Completion Date | January 2018 | ||||
| Estimated Primary Completion Date | January 2018 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 15 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00616369 | ||||
| Other Study ID Numbers ICMJE | X070116004 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. Robert C Bourge, University of Alabama at Birmingham | ||||
| Study Sponsor ICMJE | Dr. Robert C Bourge | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Alabama at Birmingham | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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