Cardiovascular DiseasesDETECTNCT01076608
DETECT-Diabetes Cardiovascular Risk-Evaluation: Targets and Essential Data for Commitment of Treatment
An observational study of Cardiovascular Diseases, run by Technische Universität Dresden.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 55,518 participants
- Where
- No sites listed yet
- Study dates
- Sep 2003to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Representative random sample of 3188 General Practitioners in Germany (general practitioners and internists serving as GPs), who included patients: * Main study: 55,518 (unselected consecutive) * Longitudinal observation study in a random subset of 7519 patients
Who may be able to join
- unselected primary care patients
Who cannot join
- none
About this study
Official title: Diabetes Cardiovascular Risk-Evaluation: Targets and Essential Data for Commitment of Treatment (DETECT)
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.
Read the detailed description
What kind of information will DETECT provide?
- 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
- Conditions
- Cardiovascular Diseases
- Keywords
- primary care patients
- Medical subject headings
- Cardiovascular Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startSep 2003
- Primary completionSep 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 55,518 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Johann Wolfgang Goethe University Hospital, Max-Planck-Institute of Psychiatry, University of Magdeburg, Medical University of Graz, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Hans-Ullrich Wittchen, Prof. Dr., Principal investigator, Director of the Institute of Clinical Psychology and Psychotherapy at the Technical University of Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01076608
- Sponsor's protocol ID
- 149092003
- Acronym
- DETECT
- Status last verified
- Feb 2010
- First submitted
- 25 Feb 2010
- Last updated
- 26 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wittchen HU, Glaesmer H, Marz W, Stalla G, Lehnert H, Zeiher AM, Silber S, Koch U, Bohler 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. doi: 10.1185/030079905X38187.
PubMed 15899112
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Cardiovascular Risk-Evaluation: Targets and Essential Data for Commitment of Treatment (DETECT)
- ClinicalTrials.gov ID
- NCT01076608
- Acronym / sponsor ID
- DETECT / 149092003
- Conditions
- Cardiovascular Diseases
- Keywords
- primary care patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55,518 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Johann Wolfgang Goethe University Hospital, Max-Planck-Institute of Psychiatry, University of Magdeburg, Medical University of Graz, Universitätsklinikum Hamburg-Eppendorf
- Study start
- Sep 2003
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 26 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
What kind of information will DETECT provide?
- 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
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Representative random sample of 3188 General Practitioners in Germany (general practitioners and internists serving as GPs), who included patients: * Main study: 55,518 (unselected consecutive) * Longitudinal observation study in a random subset of 7519 patients
Key inclusion criteria (1 listed)
- unselected primary care patients
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2010.
- Background: PubMed 15899112Wittchen HU, Glaesmer H, Marz W, Stalla G, Lehnert H, Zeiher AM, Silber S, Koch U, Bohler 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. doi: 10.1185/030079905X38187.
- Study homepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans-Ullrich Wittchen, Prof. Dr. principal investigator
Director of the Institute of Clinical Psychology and Psychotherapy at the Technical University of Dresden
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Technische Universität Dresden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01076608, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2010.