- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00616369
Identification of Genetic Markers for Cardiopulmonary Diseases (Genotype) (Genotype)
Identification of Genetic Markers for Cardiopulmonary Diseases
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Alabama
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Birmingham, Alabama, Stati Uniti, 35294
- University of Alabama @ Birmingham
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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1
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. |
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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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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.
Lasso di tempo: 10 years
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10 years
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Robert C Bourge, MD, University of Alabama at Birmingham Division of Medicine
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- X070116004
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .