- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Haifa, Israel
- Clalit Health Services, Haifa and Western Galilee District
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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same as in ICARE: composite major CVD outcomes (non fatal MI, Stroke and CVD death)
Zeitfenster: Continuously till end of June 2008
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Continuously till end of June 2008
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Shany Blum, M.D. M.Sc., Technion, Israel Institute of Technology
- Hauptermittler: Uzi Milman, M.D., Clalit Health Services
- Hauptermittler: Chen Shapira, M.D., Clalit Health Services
- Hauptermittler: Andrew P Levy, M.D. Ph.D., Technion, Israel Institute of Technology
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- KL-2007
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