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Clinical Trials/NCT03934957
NCT03934957
Recruiting
Not Applicable

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

Universitätsklinikum Hamburg-Eppendorf1 site in 1 country45,000 target enrollmentFebruary 8, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Heart Disease
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Enrollment
45000
Locations
1
Primary Endpoint
self-reported Information on changes in health in the participants
Status
Recruiting
Last Updated
7 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
February 8, 2016
End Date
December 31, 2028
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

self-reported Information on changes in health in the participants

Time Frame: yearly up to 12 years

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

Study Sites (1)

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