DETECT-Diabetes Cardiovascular Risk-Evaluation: Targets and Essential Data for Commitment of Treatment

Cardiovascular Diseases Clinical Trial

— DETECT  

Official title:

Diabetes Cardiovascular Risk-Evaluation: Targets and Essential Data for Commitment of Treatment (DETECT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076608
• Other study ID #: 149092003
• Status: Completed
• Phase: N/A
• First received: February 25, 2010
• Last updated: February 25, 2010
• Start date: September 2003
• Est. completion date: December 2008

Study information

• Verified date: February 2010
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

Cardiovascular diseases are, along with cancer, the most frequent causes for mortality and morbidity in the industrialized nations. Numerous clinical efficient approaches to reduce the known risk factors have been introduced in clinical routine care; yet with quite limited success, e.g. modification of behavioral risk factors, drug treatment and the combination of both. On the population level only marginal changes have been demonstrated, i.e. the mortality from myocardial infarction and stroke remains high.

To answer questions about underlying factors, for this unsatisfactory status, we might profit tremendously from studies that examine the situation, where treatment of patients most frequently take place: in primary care. This approach pays attention to the General Practitioner's (GP) in their gate keeping function in health care. Information from primary care in particular is largely lacking as recently stated by the "Sachverständigenrat für die konzertierte Aktion im Gesundheitswesen" in 2001. The DETECT study has been designed to address these critical issues.

On 16th and 18th September 2003, 3,188 GPs completed a standardised assessment of the diagnostic and therapeutic profile of 55,518 unselected consecutive patients. All patients completed a questionnaire on their demographic data, their complaints, their illness history, their knowledge about selected diseases and their attitude towards those. A sub sample of 7,519 patients additionally attended a standardized laboratory screening program. In this screening the focus was on blood constituents connected with cardiovascular diseases and diabetes, including e. g. cholesterol, lipoproteins, triglycerides and HbA1c. These patients were assessed a second time in the follow up period after one year in 2004 and for a final time after completion of the five-year follow-up period.

Description:

What kind of information will DETECT provide?

I. From the cross sectional part (descriptive epidemiological part on 16th/18th September 2003)

• Frequency, characteristics and severity of cardiovascular diseases, selected associated metabolic syndromes and atherosclerotic diseases and syndromes

• Identification and determination of the proportion of patients with high-risk constellations (e.g., post myocardial infarction, associated morbidities, laboratory measures)

• Rates of General Practitioners recognition, diagnostic and therapeutic profiles

• Assessment of quality of care (comparison with guidelines)

• Indicators of undertreatment, overtreatment and inadequate treatment

II. From the longitudinal part

Changes of laboratory parameters and diagnoses after one and five years, in relation to:

• Initial diagnostic and therapeutic status

• Selected intervention criteria

• Composition of risk indicators, and comparison with existing indices (PROCAM, Framingham, Score etc.)

• Measurement of frequency and point of critical outcomes e.g., myocardial infarction, associated morbidity, hospitalisation, critical medical interventions

• Significance of established and "new" cardiovascular risk factors

• Prognostic value of biomarkers for risk stratification

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55518
• Est. completion date: December 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• unselected primary care patients

Exclusion Criteria:

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Diseases

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Technische Universität Dresden	Johann Wolfgang Goethe University Hospitals, Max-Planck-Institute of Psychiatry, Medical University of Graz, Universitätsklinikum Hamburg-Eppendorf, University of Magdeburg

References & Publications (1)

Wittchen HU, Glaesmer H, März W, Stalla G, Lehnert H, Zeiher AM, Silber S, Koch U, Böhler S, Pittrow D, Ruf G; DETECT-Study Group. Cardiovascular risk factors in primary care: methods and baseline prevalence rates--the DETECT program. Curr Med Res Opin. 2005 Apr;21(4):619-30. — View Citation

External Links

•   Study homepage