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出境医 / 临床实验 / Hamburg City Health Study - a German Cohort Study (HCHS)
Hamburg City Health Study - a German Cohort Study (HCHS)
Study Description
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
| 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 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- 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
| 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
Contacts
| Contact: Annika Jagodzinski, MD | 0049741059328 | A.Jagodzinski@uke.de | |
| Contact: Tanja Zeller, Professor | 0049741056045 | t.zeller@uke.de |
Locations
| 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
| Principal Investigator: | Stefan Blankenberg, Professor | Universitäres Herzzentrum Hamburg |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | January 4, 2019 | ||||||||
| First Posted Date | May 2, 2019 | ||||||||
| Last Update Posted Date | May 2, 2019 | ||||||||
| Actual Study Start Date | February 8, 2016 | ||||||||
| Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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
|
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Hamburg City Health Study - a German Cohort Study | ||||||||
| 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 | ||||||||
| 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. | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description:
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
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| 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. | ||||||||
| Condition |
|
||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Jacobi N, Walther C, Borof K, Heydecke G, Seedorf U, Lamprecht R, Beikler T, Debus SE, Waldeyer C, Blankenberg S, Schnabel RB, Aarabi G, Behrendt CA. The Association of Periodontitis and Peripheral Arterial Occlusive Disease in a Prospective Population-Based Cross-Sectional Cohort Study. J Clin Med. 2021 May 11;10(10). pii: 2048. doi: 10.3390/jcm10102048. | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
45000 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 31, 2028 | ||||||||
| Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 45 Years to 74 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
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| Listed Location Countries | Germany | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03934957 | ||||||||
| Other Study ID Numbers | PV5131 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Universitätsklinikum Hamburg-Eppendorf | ||||||||
| Study Sponsor | Universitätsklinikum Hamburg-Eppendorf | ||||||||
| Collaborators |
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| Investigators |
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| PRS Account | Universitätsklinikum Hamburg-Eppendorf | ||||||||
| Verification Date | April 2019 | ||||||||
