Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448487
Status:
COMPLETED
Last Update Posted:
2015-06-12
First Post:
2007-03-14
Brief Title:
Haptoglobin Phenotype and Cardiovascular Complications in Diabetic Patients
Sponsor:
Dr Shany Blum
Organization:
Technion Israel Institute of Technology
Study Overview
Official Title:
Prospective Observational Study to Asses the Incidence of CVD Complications in Diabetic Patients Pre-stratified by Haptoglobin Phenotype From the I CARE Registry
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICARER
Brief Summary:
3054 diabetic patients 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 All other patients were passively followed since April 2005 for cardiovascular events We have decided to continue and follow these patients till end of December 2007 to determine the incidence of CVD in theses patients which are pre stratified by Haptoglobin Phenotype
Detailed Description:
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 patients 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
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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None