NCT06096922

Brief Summary

The main purpose of this study is to establish a frailty automatic evaluation index "AI frailty index" based on artificial intelligence multi-modal non-contact monitoring information analysis. At the same time, the study will explore the correlation between ' AI weakness index ' and perioperative and long-term prognosis and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
521

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

May 11, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

1.6 years

First QC Date

October 16, 2023

Last Update Submit

May 22, 2025

Conditions

Frailty

Keywords

FrailtyCardiac surgeryArtificial intelligenceNon-contact monitoring

Outcome Measures

Primary Outcomes (1)

  • One-dimensional matrix vector composed of five frailty scale results

    Consisting of five frailty scales: Edmonton frailty scale, FRAIL frailty scale, Fried frailty scale, Clinical frailty scale, and SPPB

    Before and after surgery, up to 2 weeks

Secondary Outcomes (11)

  • 30-day adverse events

    30 days post operative

  • 1-year adverse events

    1 year post operative

  • EQ-5D score

    1 year post operative

  • QOR-15 score

    1 year post operative

  • Edmonton frailty scale score

    1 year post operative

  • +6 more secondary outcomes

Study Arms (1)

AI frailty index establishment group

Individuals who undergo elective cardiac surgury

Other: No intervention

Interventions

No interventionOTHER

No intervention

AI frailty index establishment group

Eligibility Criteria

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

Patient aged 18 years or older, undergoing elective cardiac surgery.

You may qualify if:

  • Elective cardiac surgery

You may not qualify if:

  • Emergency surgery
  • Age ≤ 18 years
  • The clinical situation is unstable, such as frequent occurrence of coronary ischemia events, unstable heart failure, or acute events leading to severe discomfort symptoms or changes in vital signs
  • Unable to cooperate in completing research data collection due to severe neurological and psychiatric abnormalities or other reasons
  • Duration of postoperative ventilation \> 48 hours or inability to obtain scale data on the first day after surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai hospital

Beijing, Beijing Municipality, 100032, China

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Shen Lin, MD, PhD

    Chinese Academy of Medical Sciences, Fuwai Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2023

First Posted

October 24, 2023

Study Start

May 11, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

May 28, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)