NCT05435898

Brief Summary

To comprehensively evaluate subclinical organ damage of Chinese adults and its association with future cardiovascular disease and events. To observe the significance of intervention based on digital health in preventing the onset and/or progression of subclinical organ damage and cardiovascular disease and events.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
41mo left

Started Oct 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Oct 2022Sep 2029

First Submitted

Initial submission to the registry

June 23, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 28, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2029

Last Updated

June 28, 2022

Status Verified

June 1, 2022

Enrollment Period

7 years

First QC Date

June 23, 2022

Last Update Submit

June 23, 2022

Conditions

Cardiovascular DiseasesCardiovascular MorbiditySubclinical Organ DamageDigital Health

Keywords

Coronary Heart DiseaseArterial stiffnessLeft ventricular hypertrophyLeft ventricular diastolic dysfunctionIntima-media thicknessCardiovascular events

Outcome Measures

Primary Outcomes (1)

  • composite endpoint of cardiovascular events

    rate of subject with myocardial infarction, stroke, heart failure, cardiovascular death

    5 years

Secondary Outcomes (3)

  • Individual cardiovascular events

    5 years

  • all cause mortality

    5 years

  • New on-set subclinical organ damage

    5 years

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All healthy subjects having cardiovascular health check-up and patients with cardiovascular diseases in the cardiovascular research clinic of our hospital are eligible for this study

You may qualify if:

  • aged 18 years or older
  • willing to participate the study and sign informed consent
  • available for long-term follow-up

You may not qualify if:

  • severe heart disease (NYHA IV)
  • stage 4 or 5 CKD
  • malignant tumors or with life expectancy less than 5 years
  • stroke within 3 months
  • refuse to participate the study or not available for long-term follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Tenth People's Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, 200072, China

Location

Related Publications (3)

  • Wang B, Gao Y, Zhao Y, Jia P, Han J, Li H, Zhang Y, Xu Y. Prognostic Value of Angiography-Derived Index of Microcirculatory Resistance in Patients with Coronary Artery Disease Undergoing Rotational Atherectomy. Rev Cardiovasc Med. 2023 Apr 27;24(5):131. doi: 10.31083/j.rcm2405131. eCollection 2023 May.

    PMID: 39076748DERIVED

  • Hou J, Li M, Han J, Yu S, Jia X, Sun F, Zhang Y. Northern Shanghai Study II: systematic assessment and management of early organ damage and its role in preventing and reducing cardiovascular risk-protocol of a prospective study. BMJ Open. 2023 Dec 30;13(12):e073423. doi: 10.1136/bmjopen-2023-073423.

    PMID: 38159946DERIVED

  • Wang B, Gao Y, Zhao Y, Xu C, Zhao S, Li H, Zhang Y, Xu Y. The spectrum of angiography-derived IMR according to morphological and physiological coronary stenosis in patients with suspected myocardial ischemia. Clin Cardiol. 2023 May;46(5):502-511. doi: 10.1002/clc.23999. Epub 2023 Mar 1.

    PMID: 36855931DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum, Stool sample and Urine sample

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary DiseaseHypertrophy, Left VentricularVentricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular DiseasesCardiomegalyHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsVentricular Dysfunction

Study Officials

  • Yi Zhang, PhD, MD

    Shanghai 10th People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Cardiac Center

Study Record Dates

First Submitted

June 23, 2022

First Posted

June 28, 2022

Study Start

October 1, 2022

Primary Completion (Estimated)

September 30, 2029

Study Completion (Estimated)

September 30, 2029

Last Updated

June 28, 2022

Record last verified: 2022-06

Locations

CN(1)