Hamburg City Health Study - a German Cohort Study

Obesity Clinical Trial

— HCHS  

Official title:

A Single Center, Prospective, Epidemiologic Cohort Study With Emphasis on Imaging to Improve the Identification of Individuals at Risk for Major Chronic Diseases and to Improve Early Diagnosis and Survival

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03934957
• Other study ID #: PV5131
• Status: Recruiting
• Start date: February 8, 2016
• Est. completion date: December 31, 2028

Study information

• Verified date: April 2019
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Annika Jagodzinski, MD
• Phone: 0049741059328
• Email: A.Jagodzinski[@]uke.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Hamburg City Health Study (HCHS) is a large, prospective, long-term, population-based cohort study and a unique research platform and network to obtain substantial knowledge about several risk and prognostic factors in major chronic diseases.

Description:

A random sample of 45.000 participants between 45 and 74 years of age from the general population of Hamburg, Germany, will take part in an extensive baseline assessment at a dedicated study center. Participants undergo 13 validated and 5 novel examinations primarily targeting cardiac, arterio-venous and cerebral function and structure including extensive imaging examinations. The protocol includes self-ratings of life style and environmental conditions, , dietary habits, physical activity, professional life, psychosocial context, , digital media use, medical and family history as well as health care utilization patterns. The assessment is completed by genomic and proteomic characterization. Beyond the identification of classical risk factors for major chronic diseases and survivorship, the core intention is to develop complex models predicting health outcomes based on a multitude of examination data, imaging data and behavioral assessments. Participants at risk for coronary artery disease, atrial fibrillation, heart failure, stroke and dementia will be invited for a visit to conduct additional MRI examination either of heart or brain. Endpoint assessment of the overall sample will be completed through repeated follow-up examinations and data from involved health and pension insurances.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45000
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 74 Years

Eligibility

Inclusion Criteria:

• Inhabitant of the city of Hamburg at the time of inclusion into the study (Inclusion is time of written consent)

• Age 45 to 74 years

• Personally signed informed consent

Exclusion Criteria:

• Insufficient knowledge of the German language, in order to understand study documents and computer assisted interview without translation

• Physical or psychological incapability to travel to the study center and to cooperate in the investigations

Related Conditions & MeSH terms

• Cancer
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Dementia
• Health Care
• Heart Diseases
• Myocardial Ischemia
• Obesity
• Ocular Diseases
• Periodontal Diseases
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases
• Stroke
• Vascular Diseases

Locations

Country	Name	City	State
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg

Sponsors (3)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	Martini-Klinik am UKE GmbH, Universitäres Herzzentrum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	self-reported Information on changes in health in the participants	coronary artery disease atrial fibrillation heart failure dementia stroke cancer such as prostate cancer and skin cancer chronic kidney diseases migraine musculoskeletal diseases such as osteoporosis and bone metastasis ocular diseases such as glaucoma, macular degeneration, fundus hypertonicus, retinal vessel disease and neoplasm oral health including periodontal disease, oropharyngeal cancer and human papillomavirus (HPV)-infection psychiatric and psychosomatic disorders such as mental disorder or late - last depression pulmonary diseases such as obstructive lung disease sexual disorder skin diseases such as psoriasis, chronic wounds and inflammation vascular diseases such as aortic aneurysm, thrombosis and peripheral arterial disease	yearly up to 12 years

External Links

•   Homepage Hamburg City Health Study