Prognosis in the Elderly Chinese: the Northern Shanghai S... | NCT02368938

Studies
Prognosis in the Elderly Chinese: the Northern Shanghai Study

NCT02368938

Sponsor

Shanghai 10th People's Hospital

Status

Unknown status

Last Update Posted

Feb 23, 2015Estimated

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Cardiovascular Risk Factor

Interventions

Not provided

Countries

Not provided

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

Feb 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Sep 2017Estimated

Completion Date

Not provided

First Submitted Date

Feb 15, 2015

First Submission Date that Met QC Criteria

Feb 20, 2015

First Posted Date

Feb 23, 2015Estimated

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

Feb 20, 2015

Last Update Posted Date

Feb 23, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ya-Wei Xu, Professor in medicine, clinical chief, Shanghai 10th People's HospitalPrincipal Investigator

Lead Sponsor

Shanghai 10th People's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 Northern Shanghai Study is a prospective community-based study, which is aimed to investigate the prognostic factors, including conventional cardiovascular risk factors and asymptomatic target organ damage, for mortality and cardiovascular diseases, in 5,000 elderly Chinese.

Detailed Description

Not provided

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

Retention

Enrollment

5,000Estimated

Label	Type	Description	Intervention Names
Several communities in the north of Shanghai

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
all-cause and cardiovascular mortality, cardiovascular events		one year
Cardiovascular diseases		one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age≥65 years old(depending on identity card);
informed consent should be signed voluntarily;
the individuals are long-term residents in northern Shanghai.

Exclusion Criteria:

is diagnosed serious heart disease (NYHA>IV) or end stage renal disease (CKD > 4);
suffered with cancer and life expectancy was less than 5 years;
has stroke within 3 months;
is not willing to participate in the clinical study;
suffered with other disease to quite the trial;
violated the protocol;
lost contact with laboratory staff.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

5000 subjects aged over 65 years old, living in communities located in the northern Shanghai, will be invited to participate in the present study, if they are willing to give their written informed consents.

Sampling Method

Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41467407	Derived	Han J, Tang J, Zhao Y, Xiong J, Zhao S, Yue W, Xu Y, Yu S, Zhang Y; Northern Shanghai Study. Subendocardial Viability Ratio Is Associated With Target Organ Damage and Hints at a Potential Independent Predictor of Cardiovascular Mortality in Older Adults: A Prospective Cohort Study. J Am Heart Assoc. 2026 Jan 6;15(1):e043643. doi: 10.1161/JAHA.125.043643. Epub 2025 Dec 30.
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