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Hamburg City Health Study - a German Cohort Study (HCHS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03934957
Recruitment Status : Recruiting
First Posted : May 2, 2019
Last Update Posted : May 2, 2019
Sponsor:
Collaborators:
Universitäres Herzzentrum Hamburg-Eppendorf
Martini-Klinik am UKE GmbH
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Study Description
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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.

Condition or disease
Coronary Heart Disease Stroke Dementia Cancer Health Care Vascular Diseases Periodontal Diseases Ocular Diseases Respiratory Disease Obesity

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 45000 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : February 8, 2016
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
serum, plasma (EDTA, citrate), genomic deoxyribonucleic acid (DNA), ribonucleic acid (RNA) from whole blood and peripheral blood mononuclear cells (PBMCs), blood cells (erythrocytes, PBMCs), urine, saliva, tooth fluid, tonsils swabs

Eligibility Criteria
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Ages Eligible for Study:   45 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Population based cohort, participants are identified by a random sample from the official inhabitant data file divided into gender and six age strata.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03934957


Contacts
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Contact: Annika Jagodzinski, MD 0049741059328 A.Jagodzinski@uke.de
Contact: Tanja Zeller, Professor 0049741056045 t.zeller@uke.de

Locations
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Germany
Universitätsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Susannw Bruder    00494056045    s.bruder@uke.de   
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Universitäres Herzzentrum Hamburg-Eppendorf
Martini-Klinik am UKE GmbH
Investigators
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Principal Investigator: Stefan Blankenberg, Professor Universitäres Herzzentrum Hamburg
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03934957    
Other Study ID Numbers: PV5131
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Epidemiology
prospective cohort study
Nutrition
prevention
psychiatric and psychosomatic disorders
Additional relevant MeSH terms:
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Periodontal Diseases
Respiratory Tract Diseases
Respiration Disorders
Heart Diseases
Vascular Diseases
Coronary Disease
Coronary Artery Disease
 Myocardial Ischemia
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Mouth Diseases
Stomatognathic Diseases