Diabetic Under 70 (Diabetics Below 70)

October 29, 2014 updated by: AstraZeneca
A screening project of diabetics with a very high cardiovascular risk (e.g. diabetes plus coronary heart disease) who already receive cholesterol-lowering therapy. Lipid profile and rate of patients who are treated to target (which is <70mg/dl for such patients with very high risk) are screened. The doctors therapy decisions after the screening will be documented and 8-10 weeks later the lipid profile of each patient will be evaluated again. Our aim is to evaluate dosing habits, to evaluate how many patients are treated to their LDL-C target and to underline the importance of treating patients to their cholesterol targets.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

685

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Male and female secondary prevention patients with: coronary disease with event: acute coronary syndrome, status post MI, PTCA, CABG, angiographically verified), PAVK (min. IIb or S.p. revascularization), stroke/TIA, carotis-plaque (asymptomatic min. 70% or S.p. revascularization), Diabetes Mellitus (type I, II)

Description

Inclusion Criteria:

  • Diabetics with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PAVK, etc.) who already receive cholesterol-lowering therapy

Exclusion Criteria:

  • Diabetics w/o CVD; diabetics who do not receive cholesterol-lowering therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Patients at very high risk
Patients at high risk
Patients at medium risk
Patients at low risk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cholesterol levels
Time Frame: After 4 weeks
Cholesterol levels from high risk patients after 4 weeks of cholesterol-lowering drug therapy under target values
After 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Chair: Michael Roden, MD, Chairs of the Austrian Diabetes Society

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

August 14, 2007

First Submitted That Met QC Criteria

August 14, 2007

First Posted (Estimate)

August 15, 2007

Study Record Updates

Last Update Posted (Estimate)

October 30, 2014

Last Update Submitted That Met QC Criteria

October 29, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-CAT-CRE-2007/3
  • NIS-CAT-DUM-2007/3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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