Comorbidities and Coexisting ConditionsNCT05797402
Clinical and Biological Sample Database of Chinese Elderly Patients With Multiple Diseases
An observational study of Comorbidities and Coexisting Conditions and Old Age; Debility, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
The investigators aim to establish a clinical database and biobank for elderly patients with multiple diseases. The collected data will include demographic information, comorbidity characteristic, FRAIL scale, age-adjusted Charlson comorbidity index, relevant blood tests, the results of imaging examination… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Comorbidities and Coexisting Conditions, Old Age; Debility
- How many people
- 10,000,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2013to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: hospital based group
Who may be able to join
- (1) written and informed consent, (2) participants aged 18 years or older.
Who cannot join
- (1) Unwilling to participate in the study, (2) Unable or unwilling to cooperate with the baseline or follow-up data collection.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing, 100029
Shao-Ping Nie, MD, PhD, 86-10-84005256, spnie@ccmu.edu.cn
Shao-Ping Nie, MD, PhD
About this study
Official title: Construction of Integrated Management and Sharing Platform for Clinical and Biological Sample Database of Chinese Elderly Patients With Multiple Diseases
The investigators aim to establish a clinical database and biobank for elderly patients with multiple diseases. The collected data will include demographic information, comorbidity characteristic, FRAIL scale, age-adjusted Charlson comorbidity index, relevant blood tests, the results of imaging examination, prescription of drugs, length of hospital stay, number of overall rehospitalizations and death. With this database, the investigators intend to formulate an individualized treatment strategy for these patients.
Read the detailed description
According to the China Health and Aging Tracking Survey, a significant proportion of elderly individuals aged over 65 suffer from two or more chronic diseases, with prevalence rates ranging from 22.5% to 47.5%. However, due to the decentralized storage of health data, lack of standardization, and collaboration barriers, it is challenging to make use of this information in a meaningful way.Therefore, there is an urgent need to overcome the technical challenges and build an intelligent diagnosis and treatment system for this vulnerable population.
To achieve this goal, it is necessary to establish a clinical database and biobank that includes data on all elderly patients with multimorbidity. This will enable researchers to conduct clinical research on various factors, including clinical and biological predictors of adverse events such as emergency visits, strokes, heart failure, myocardial infarction, tumors, and acute chronic obstructive pulmonary disease. Additionally, the database will facilitate the development of systematic and individualized evaluation tools for elderly patients with multimorbidity, identify prognostic factors that improve short- and long-term outcomes, and enable the participation in multi-center trials at the national or international level. Ultimately, this effort will help establish clinical database and biobank data collection standards for future studies.
- Keywords
- Cognition Disorders, Frailty, Coronary heart disease, Atrial fibrillation, Stroke, Heart failure, Hypertension, Valvular heart disease
- Medical subject headings
- Frailty, Cognition Disorders, Coronary Disease, Atrial Fibrillation, Stroke, Heart Failure, Hypertension, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| young-aged patients | Patients aged 18 to 45 years old. | |
| middle-aged patients | Patients aged 46 to 64 years old. | |
| elderly patients | Patients aged 65 and older. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of geriatric syndromes including falls, cognitive impairment, dizziness and frailty
collection of clinical data in the medical record and follow-up update
Measured: 1 year
Secondary outcomes (1)
The incidence of survival rate
collection of clinical data in the medical record and follow-up update
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start1 Jan 2013
- Primary completion15 May 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Comorbidities and Coexisting ConditionsStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 10,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital, Beijing Chao Yang Hospital, Beijing Tiantan Hospital, Beijing Geriatric Hospital, China-Japan Friendship Hospital, Xuanwu Hospital, Beijing, Wuhan TongJi Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing Friendship Hospital
- Responsible party
- Principal investigator, Shao-Ping Nie, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797402
- Sponsor's protocol ID
- 2020YFC2004800
- Status last verified
- Apr 2023
- First submitted
- 22 Feb 2023
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Huang X, Zheng W, Wang X, Suo M, Zhao X, Nie S. Association between Charlson Comorbidity Index and in-hospital outcomes among aortic stenosis patients undergoing aortic valve replacement: an observational study at the National Clinical Research Center for Cardiovascular Diseases. BMJ Open. 2025 Jun 17;15(6):e083677. doi: 10.1136/bmjopen-2023-083677.
PubMed 40527568Zheng W, Huang X, Wang X, Suo M, Yan Y, Gong W, Ai H, Que B, Nie S. Impact of multimorbidity patterns on outcomes and treatment in patients with coronary artery disease. Eur Heart J Open. 2024 Mar 27;4(2):oeae009. doi: 10.1093/ehjopen/oeae009. eCollection 2024 Mar.
PubMed 38544919
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of Integrated Management and Sharing Platform for Clinical and Biological Sample Database of Chinese Elderly Patients With Multiple Diseases
- ClinicalTrials.gov ID
- NCT05797402
- Acronym / sponsor ID
- 2020YFC2004800
- Keywords
- Cognition Disorders, Frailty, Coronary heart disease, Atrial fibrillation, Stroke, Heart failure, Hypertension, Valvular heart disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000,000 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital, Beijing Chao Yang Hospital, Beijing Tiantan Hospital, Beijing Geriatric Hospital, China-Japan Friendship Hospital, Xuanwu Hospital, Beijing, Wuhan TongJi Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing Friendship Hospital
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to establish a clinical database and biobank for elderly patients with multiple diseases. The collected data will include demographic information, comorbidity characteristic, FRAIL scale, age-adjusted Charlson comorbidity index, relevant blood tests, the results of imaging examination, prescription of drugs, length of hospital stay, number of overall rehospitalizations and death. With this database, the investigators intend to formulate an individualized treatment strategy for these patients.
Detailed description
According to the China Health and Aging Tracking Survey, a significant proportion of elderly individuals aged over 65 suffer from two or more chronic diseases, with prevalence rates ranging from 22.5% to 47.5%. However, due to the decentralized storage of health data, lack of standardization, and collaboration barriers, it is challenging to make use of this information in a meaningful way.Therefore, there is an urgent need to overcome the technical challenges and build an intelligent diagnosis and treatment system for this vulnerable population.
To achieve this goal, it is necessary to establish a clinical database and biobank that includes data on all elderly patients with multimorbidity. This will enable researchers to conduct clinical research on various factors, including clinical and biological predictors of adverse events such as emergency visits, strokes, heart failure, myocardial infarction, tumors, and acute chronic obstructive pulmonary disease. Additionally, the database will facilitate the development of systematic and individualized evaluation tools for elderly patients with multimorbidity, identify prognostic factors that improve short- and long-term outcomes, and enable the participation in multi-center trials at the national or international level. Ultimately, this effort will help establish clinical database and biobank data collection standards for future studies.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| young-aged patients | – | –Patients aged 18 to 45 years old. |
| middle-aged patients | – | –Patients aged 46 to 64 years old. |
| elderly patients | – | –Patients aged 65 and older. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- hospital based group
Key inclusion criteria (1 listed)
- (1) written and informed consent, (2) participants aged 18 years or older.
Key exclusion criteria (1 listed)
- (1) Unwilling to participate in the study, (2) Unable or unwilling to cooperate with the baseline or follow-up data collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence of geriatric syndromes including falls, cognitive impairment, dizziness and frailty
Time frame: 1 year
collection of clinical data in the medical record and follow-up update
1 secondary outcome
The incidence of survival rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Derived from this study: PubMed 40527568Huang X, Zheng W, Wang X, Suo M, Zhao X, Nie S. Association between Charlson Comorbidity Index and in-hospital outcomes among aortic stenosis patients undergoing aortic valve replacement: an observational study at the National Clinical Research Center for Cardiovascular Diseases. BMJ Open. 2025 Jun 17;15(6):e083677. doi: 10.1136/bmjopen-2023-083677.
- Derived from this study: PubMed 38544919Zheng W, Huang X, Wang X, Suo M, Yan Y, Gong W, Ai H, Que B, Nie S. Impact of multimorbidity patterns on outcomes and treatment in patients with coronary artery disease. Eur Heart J Open. 2024 Mar 27;4(2):oeae009. doi: 10.1093/ehjopen/oeae009. eCollection 2024 Mar.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Comorbidities and Coexisting Conditions and Old Age; Debility, run by Beijing Anzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shao-ping Nie, MD,PhD (8613701186772, spnie@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of geriatric syndromes including falls, cognitive impairment, dizziness and frailty (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05797402, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.