Clinical and Biological Sample Database of Chinese Elderl... | NCT05797402

Studies
Clinical and Biological Sample Database of Chinese Elderly Patients With Multiple Diseases

NCT05797402

Sponsor

Beijing Anzhen Hospital

Status

Unknown status

Last Update Posted

Apr 4, 2023Actual

Enrollment

10,000,000Estimated

Phase

Not provided

Conditions

Comorbidities and Coexisting Conditions
Old Age; Debility

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2013Actual

Primary Completion Date

May 15, 2023Estimated

Completion Date

Jun 2023Estimated

First Submitted Date

Feb 22, 2023

First Submission Date that Met QC Criteria

Apr 2, 2023

First Posted Date

Apr 4, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2023

Last Update Posted Date

Apr 4, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shao-Ping Nie, Professor of Medicine,Director,Department of Cardiology, Beijing Anzhen HospitalPrincipal Investigator

Lead Sponsor

Beijing Anzhen HospitalOTHER

Collaborators

Name	Class
Chinese PLA General Hospital	OTHER
Beijing Chao Yang Hospital	OTHER
Beijing Tiantan Hospital	OTHER
Beijing Geriatric Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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, 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incidence of geriatric syndromes including falls, cognitive impairment, dizziness and frailty	collection of clinical data in the medical record and follow-up update	1 year

Secondary Outcomes

Measure	Description	Time Frame
The incidence of survival rate	collection of clinical data in the medical record and follow-up update	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

(1) written and informed consent, (2) participants aged 18 years or older.

Exclusion Criteria:

(1) Unwilling to participate in the study, (2) Unable or unwilling to cooperate with the baseline or follow-up data collection.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

hospital based group

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shao-ping Nie, MD,PhD	Contact	8613701186772		spnie@ccmu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Anzhen Hospital, Capital Medical University	Recruiting	Beijing		100029	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40527568	Derived	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.
38544919

ID	Term
D000073496	Frailty
D003072	Cognition Disorders
D003327	Coronary Disease
D001281	Atrial Fibrillation
D020521	Stroke
D006333	Heart Failure
D006973	Hypertension
D006349	Heart Valve Diseases

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D019965	Neurocognitive Disorders
D001523	Mental Disorders