- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00448487
Haptoglobin Phenotype and Cardiovascular Complications in Diabetic Patients (ICARER)
Prospective Observational Study to Asses the Incidence of CVD Complications in Diabetic Patients Pre-stratified by Haptoglobin Phenotype From the I CARE Registry
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
3054 diabetic patients from Clalit Medical Services were screened for Haptoglobin Phenotype as part of the ICARE study (NCT00220831) and composite the I CARE registry, 1434 Hp 2-2 patients were treated as part of the I CARE study with vitamin E vs. Placebo, this study was recently terminated due to significant differences between the groups and data was sent to publication.
During the follow up period of the I CARE study all 3054 registry patients were followed in a passive way, which means that the patients were not called for follow up visits but the reports for CVD events were centrally collected from patient's Hospital admission summaries. Admission summaries were collected using the computerized systems of the Clalit Health Services assuring that when ever a patient in the registry is hospitalized for what ever reason the study coordination them would be aware of that and receive the admission summary. An events adjudication committee adjudicated each event in a blinded fashion to determine the nature of the events.
1434 patients who were treated by vitamin E or placebo in the I CARE study were also followed by follow-up telephone calls.
once I CARE study was officially terminated we have decided to continue and follow the whole 3054 registry patients in the same manner to complete a nearly 3 year follow up to determine in a prospective manner the incidence of CVD events in Diabetic patients which were pre-stratified by Haptoglobin type.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
-
Haifa, Israele
- Clalit Health Services, Haifa and Western Galilee District
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
These are the same patients as in I CARE registry so the criteria are the same as was for I CARE study Recruitment phase.
Inclusion Criteria:
- Diabetic patients aged 55 and above
Exclusion Criteria:
- Patient who takes antioxidant treatment will be asked to stop, or can't be included in the study
- Patients who had a CVD incident (MI, Stroke, TIA), Unstable angina pectoris, Uncontrolled HTN, will have to wait a month after stabilization to be included in the study
- Allergy to Vitamin E
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
same as in ICARE: composite major CVD outcomes (non fatal MI, Stroke and CVD death)
Lasso di tempo: Continuously till end of June 2008
|
Continuously till end of June 2008
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Shany Blum, M.D. M.Sc., Technion, Israel Institute of Technology
- Investigatore principale: Uzi Milman, M.D., Clalit Health Services
- Investigatore principale: Chen Shapira, M.D., Clalit Health Services
- Investigatore principale: Andrew P Levy, M.D. Ph.D., Technion, Israel Institute of Technology
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
- KL-2007
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 .