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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00111059
Other study ID # 1
Secondary ID
Status Recruiting
Phase N/A
First received May 16, 2005
Last updated June 23, 2005
Start date January 2005
Est. completion date April 2006

Study information

Verified date May 2005
Source University Hospital, Saarland
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

Cardiovascular risk factors and psycho-social characteristics will be determined in obese and non-obese patients in the setting of primary medical care.


Description:

Cardiovascular risk factors and psycho-social characteristics will be determined using a questionnaire in primary care physician offices in the city of Merzig, Germany. We will recruit all people (age>18y) with a body-mass index (BMI) > 30 kg/m2 plus patients in the two following participating physician offices: Praxisnetz and Merzig. Cardiovascular risk will be assessed using the PROCAM (Munster Heart Study), ESC (European Society of Cardiology) and Framingham risk scores. Psycho-social factors will be recorded according to the methodology of the INTERHEART study.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date April 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age 18 or > 18

- BMI > 30 kg/m2

- Presenting to a participating primary care physician

Exclusion Criteria:

- Age < 18

Study Design

Observational Model: Case Control, Primary Purpose: Screening, Time Perspective: Cross-Sectional


Locations

Country Name City State
Germany Klinik Innere Medizin III, Universitätsklinikum des Saarlandes Homburg Saarland
Germany Praxisnetz Merzig Merzig Saarland

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Saarland

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Assmann G, Cullen P, Schulte H. Simple scoring scheme for calculating the risk of acute coronary events based on the 10-year follow-up of the prospective cardiovascular Münster (PROCAM) study. Circulation. 2002 Jan 22;105(3):310-5. Erratum in: Circulation 2002 Feb 19;105(7):900. — View Citation

Rosengren A, Hawken S, Ounpuu S, Sliwa K, Zubaid M, Almahmeed WA, Blackett KN, Sitthi-amorn C, Sato H, Yusuf S; INTERHEART investigators. Association of psychosocial risk factors with risk of acute myocardial infarction in 11119 cases and 13648 controls from 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):953-62. — View Citation

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