Incidence of Cardiovascular Disease (CVD) Complications in Diabetic Patients Pre-Stratified by Haptoglobin Phenotype

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Uzi Milman, Clalit Health Services
ClinicalTrials.gov Identifier:
NCT00872456
First received: March 30, 2009
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

Study participants were individuals with Diabetes Mellitus (DM) that were Haptoglobin (Hp) genotyped for the ICARE study (NCT00220831 - completed). Individuals were eligible for inclusion in the ICARE study if they had DM and were 55 years of age or older. Initially informed consent for Hp genotyping and inclusion in the cohort was obtained; Between March 13, 2005 and April 13, 2006 Hp genotype was tested on 3044 individuals with the distribution: Hp 1-1 285 (9.4%); Hp 2-1 1248 (41.0%); Hp 2-2 1511 (49.6%). All genotyped DM individuals constitute the ICARE cohort. Non interventional follow up for all recruited individuals was initiated at enrollment by allocating a unique identifier that enabled access to the computerized medical records of each one of them; This source includes all real life medical information on each individual; including values of all laboratory tests and clinical measurements, (such as HbA1c, lipid profile, blood pressure and weight; date and value of each measurement); all dispensed medications (retrieved monthly and including date, dose and amount dispensed). A central laboratory, that was unaware of the individual's Hp type, analyzed all laboratory tests. All treatment decisions, regarding all aspects of care and follow up of the study participants, remained at the discretion of the individual's primary care physician that was blinded to the individual's Hp type. The study team was blinded to the treatment provided to the study participants by the primary care team, and actually had no contact with them. Events were ascertained by reviewing all hospitalizations of study participants. Adjudication of events corresponding to the study outcomes was based on the discharge summaries of all hospitalizations and done by a panel of physicians blinded to the individual's Hp type. For out-of-hospital deaths, adjudication was based on interviews with the participant's physician and family when needed.

Hypothesis: strict glucose control (HbA1c<7%) reduces the rate of cardiovascular events only to diabetic patients with the Hp 2-2 phenotype. We also postulated that, since Hp 2-2 DM individuals are at an increased genetic susceptibility for cardiovascular disease (CVD), this unique cohort merits an investigation on the associations between various CVD risk variables and CVD events and establish whether any evident association was dependent of the individual's Hp type.


Condition
Diabetes
Cardiovascular Disease
Myocardial Infarction
Stroke

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study to Asses the Incidence of CVD Complications in Diabetic Patients Pre-Stratified by Haptoglobin Phenotype

Resource links provided by NLM:


Further study details as provided by Clalit Health Services:

Primary Outcome Measures:
  • Composite of major CVD events (non fatal MI, Stroke and CVD death) [ Time Frame: Data retrived continuously till end of 2015 ] [ Designated as safety issue: No ]
    Clinical data (eg. BP, weight, smoking, etc) medications use, Lab tests and reports on CVD events will be centrally collected from patient's records and Hospital admission summaries. Admission summaries are retrieved using the computerized systems of Clalit Health Services assuring that whenever a patient in the registry is hospitalized the admission summary is retrieve. An events adjudication committee will assess each event in a blinded fashion to determine the nature of the events.


Secondary Outcome Measures:
  • Non cardiovascular death [ Time Frame: Data retrived continuously till end of 2015 ] [ Designated as safety issue: No ]
    Clinical data (eg. BP, weight, smoking, etc) medications use, Lab tests and reports on CVD events will be centrally collected from patient's records and Hospital admission summaries. Admission summaries are retrieved using the computerized systems of Clalit Health Services assuring that whenever a patient in the registry is hospitalized the admission summary is retrieve. An events adjudication committee will assess each event in a blinded fashion to determine the nature of the events.

  • Revascularization procedures [ Time Frame: Data retrived continuously till end of 2015 ] [ Designated as safety issue: No ]
    Clinical data (eg. BP, weight, smoking, etc) medications use, Lab tests and reports on CVD events will be centrally collected from patient's records and Hospital admission summaries. Admission summaries are retrieved using the computerized systems of Clalit Health Services assuring that whenever a patient in the registry is hospitalized the admission summary is retrieve. An events adjudication committee will assess each event in a blinded fashion to determine the nature of the events.


Enrollment: 3054
Study Start Date: March 2005
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients recruited from primary care clinics. All are diabetic patients 55 years old or older at the time of ICARE initiation (2005).

Criteria

Inclusion Criteria:

  • Diabetic patients
  • 55 years old or older at the time of ICARE initiation.
  • Known haptoglobin genotype
  • Signed informed consent for ICARE study and registry
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00872456

Sponsors and Collaborators
Clalit Health Services
Investigators
Principal Investigator: Uzi Milman, MD Clalit Health Services, Haifa and Western Galilee District, Haifa, Israel.
Principal Investigator: Chen Shapira, MD Carmel Medical Center, Clalit Health Services
  More Information

No publications provided

Responsible Party: Uzi Milman, Principal Investigator, Clalit Health Services
ClinicalTrials.gov Identifier: NCT00872456     History of Changes
Other Study ID Numbers: CMC 08-0090CTIL
Study First Received: March 30, 2009
Last Updated: October 10, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Clalit Health Services:
Diabetes Mellitus
Cardiovascular Disease
Haptoglobin

Additional relevant MeSH terms:
Cardiovascular Diseases
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014