Intermountain INSPIRE Registry
INtermountain Healthcare Biological Samples Collection Project and Investigational REgistry for the On-going Study of Disease Origin, Progression and Treatment (Intermountain INSPIRE Registry)
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
This is an observational, non-randomized, open, long-term project to collect a variety of biological samples, in addition to usual or specialized care clinical information and laboratory test results, from patients who present to Intermountain Healthcare-affiliated facilities, with symptoms of any healthcare-related conditions, as well as from a general population including disease-free subjects. The INSPIRE Registry will include all subjects enrolled in the HHD registry (IRB # 1007406, approval date 01- 16-2009) and the cathlab database registry (IRB # 1008366, approval date 10/04/2000), as of IRB approval date of this INSPIRE amended protocol.
Since this is a registry database project, there are no investigational treatments, drugs or procedures associated with participation. Information obtained from this registry project will not have direct or immediate benefit for any of the participants.
Biological samples and subject information will be obtained during diagnostic procedures and/or treatment that are generally part of usual or specialized care for the underlying healthcare-related condition. Sample testing and registry data utilization for various research projects can be initiated only after the appropriate approval is obtained from a registry oversight/management committee, and when appropriate, the Institutional Review Board.
After informed consent is obtained from the patient, the biological samples will be obtained in one of the following ways:
- During a procedure from access lines inserted for the procedure, or
- When other ordered lab work is done, or
- As a separate sample collection if no other lab work is planned. Biological sample collection from the general population may be a separate blood draw and/or sample collection. Participating patients may be asked to provide one or more collections of biological samples. Biological samples may be used in current and future research tests multiple times, or until the sample is consumed. In addition, participating subjects may be asked to complete the IRBreviewed questionnaires.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Contatto studio
- Nome: Joseph B Muhlestein, MD
- Numero di telefono: 801-507-4701
- Email: brent.muhlestein@imail.org
Backup dei contatti dello studio
- Nome: Patti Spencer
- Numero di telefono: 801-507-4778
- Email: patti.spencer@imail.org
Luoghi di studio
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Utah
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Murray, Utah, Stati Uniti, 84143
- Reclutamento
- Intermountain Medical Center and Intermountain Clinics
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Contatto:
- Joseph B Muhlestein, MD
- Numero di telefono: 801-507-4701
- Email: brent.muhlestein@imail.org
-
Contatto:
- Patti Spencer
- Numero di telefono: 801-507-4778
- Email: patti.spencer@imail.org
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Males or females of any age, any ethnicity, diagnosed with any healthcare-related conditions, presenting to an Intermountain Healthcare-affiliated facility or males or females of any age, any ethnicity, with or without any healthcare-related conditions, including disease-free subjects, from a general population that may include unaffected family members
- Patient or patient's representative has the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures, using a form that is approved by the applicable IRB.
Exclusion Criteria:
- Inability or refusal of the patient and/or the patient's legally-acceptable representative to provide informed consent for any reason.
- Other conditions that in the opinion of the Principal Investigator or Co-Investigator(s) may increase risk to the subject and/or compromise the quality of the registry project.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Ecologico o comunitario
- Prospettive temporali: Prospettiva
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Mortalità per tutte le cause
Lasso di tempo: 10 anni
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10 anni
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
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 (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 1024811
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 .