FrailtyNCT06096922
AI-based Frailty Assessment Tool for Patients Undergoing Cardiac Surgery
An observational study of Frailty, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frailty
- How many people
- 521 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2023to 31 Dec 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patient aged 18 years or older, undergoing elective cardiac surgery.
Who may be able to join
- Elective cardiac surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Frailty Assessment Tool for Patients Undergoing Cardiac Surgery Based on Artificial Intelligence Multimodal Non-contact Monitoring.
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.
Read the detailed description
This is a prospective cohort study. Patients who undergoes elective cardiac surgery will be enrolled. We collect frailty scales, clinical information and multi-modal, non-contact monitoring information during hospitalization. One-year follow-up will be done. The non-contact monitoring information are used to predict the frailty scales to establish and validate an AI-based frailty assessment model "AI frailty index". The AI frailty index will be further used to predict perioperative and long-term outcomes.
- Conditions
- Frailty
- Being tested
- No intervention
- Keywords
- Frailty, Cardiac surgery, Artificial intelligence, Non-contact monitoring
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| AI frailty index establishment group | Individuals who undergo elective cardiac surgury Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Before and after surgery, up to 2 weeks
Secondary outcomes (11)
30-day adverse events
Including death, readmission, stroke, myocardial infarction, renal insufficiency or renal failure, dialysis, atrial fibrillation, peripheral vascular embolism, bleeding events, heart failure
Measured: 30 days post operative
1-year adverse events
Including death, readmission, stroke, myocardial infarction, renal insufficiency or renal failure, dialysis, atrial fibrillation, peripheral vascular embolism, bleeding events, heart failure
Measured: 1 year post operative
EQ-5D score
The score of EQ-5D questionnaire
Measured: 1 year post operative
QOR-15 score
The score of QOR-15 questionnaire
Measured: 1 year post operative
Edmonton frailty scale score
The Edmonton frailty scale consists of 11 items for a composite score of 0 to 17, and higher scores mean a worse outcome.
Measured: 1 year post operative
FRAIL frailty scale score
The FRAIL frailty scale consists of 5 items, with 3 of 5 required to diagnose frailty.
Measured: 1 year post operative
Fried frailty scale score
The Fried frailty scale consists of 5 items, with 3 of 5 required to diagnose frailty.
Measured: 1 year post operative
Clinical frailty scale score
The Clinical frailty scale is scored 1 to 9 based on a semiquantitative evaluation of the patient's symptoms, mobility, inactivity, exhaustion, and disability for basic activities of daily living and instrumental activities of daily living, and higher scores mean a worse outcome.
Measured: 1 year post operative
Short Physical Performance Battery scale score
The Short Physical Performance Battery scale consists of 3 physical tests, with each scored 0 to 4 for a composite score of 0 to 12, and higher scores mean a better outcome.
Measured: 1 year post operative
Perioperative adverse events
Including all cause death, stroke, renal insufficiency, deep sternal wound infection, and reoperation
Measured: From surgery to discharge, up to 7 days
Area under receiver operating curve (AUC)
Area under receiver operating curve of algorithm in predicting frailty scales and outcomes
Measured: At the end of follow-up (1 mouth)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start11 May 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- Prospective
- Enrolment
- 521 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shen Lin, MD, PhD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096922
- Sponsor's protocol ID
- 2023-GSP-RC-10
- Status last verified
- May 2025
- First submitted
- 16 Oct 2023
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty Assessment Tool for Patients Undergoing Cardiac Surgery Based on Artificial Intelligence Multimodal Non-contact Monitoring.
- ClinicalTrials.gov ID
- NCT06096922
- Acronym / sponsor ID
- 2023-GSP-RC-10
- Conditions
- Frailty
- Keywords
- Frailty, Cardiac surgery, Artificial intelligence, Non-contact monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 521 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 11 May 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 24 Oct 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 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.
Detailed description
This is a prospective cohort study. Patients who undergoes elective cardiac surgery will be enrolled. We collect frailty scales, clinical information and multi-modal, non-contact monitoring information during hospitalization. One-year follow-up will be done. The non-contact monitoring information are used to predict the frailty scales to establish and validate an AI-based frailty assessment model "AI frailty index". The AI frailty index will be further used to predict perioperative and long-term outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AI frailty index establishment group | – | Other: No interventionIndividuals who undergo elective cardiac surgury |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient aged 18 years or older, undergoing elective cardiac surgery.
Key inclusion criteria (1 listed)
- Elective cardiac surgery
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | AI frailty index establishment group |
Primary outcome
One-dimensional matrix vector composed of five frailty scale results
Time frame: Before and after surgery, up to 2 weeks
Consisting of five frailty scales: Edmonton frailty scale, FRAIL frailty scale, Fried frailty scale, Clinical frailty scale, and SPPB
11 secondary outcomes
30-day adverse events
Time frame: 30 days post operative
1-year adverse events
Time frame: 1 year post operative
EQ-5D score
Time frame: 1 year post operative
QOR-15 score
Time frame: 1 year post operative
Edmonton frailty scale score
Time frame: 1 year post operative
FRAIL frailty scale score
Time frame: 1 year post operative
Fried frailty scale score
Time frame: 1 year post operative
Clinical frailty scale score
Time frame: 1 year post operative
Short Physical Performance Battery scale score
Time frame: 1 year post operative
Perioperative adverse events
Time frame: From surgery to discharge, up to 7 days
Area under receiver operating curve (AUC)
Time frame: At the end of follow-up (1 mouth)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
Related trials for Frailty
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Not yet recruiting
Adapting an Evidence-Based Physical Activity Intervention to Prevent Frailty and Functional Decline in Older Women Living With HIV
Mobility Impairment, Frailty
Recruiting
Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
Mobility Limitation, Frailty
Not yet recruiting
Virtual Reality Multidomain Training for Older Adults With Cognitive Frailty
Cognitive Frailty
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.
Shen Lin, MD, PhD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
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 Frailty, run by China National Center for Cardiovascular Diseases 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 5 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: finished, as of the sponsor's last update on 28 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-dimensional matrix vector composed of five frailty scale results (time frame: Before and after surgery, up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2025.