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Study on Cardiac Output Evaluation Based on Wearable Monitoring Data

Study on Cardiac Output Evaluation Based on Wearable Monitoring Data

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06938893
Enrollment
300
Registered
2025-04-22
Start date
2025-04-20
Completion date
2026-12-31
Last updated
2025-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Output

Brief summary

Based on the monitoring data of wearable devices, with cardiac output (CO) as the gold standard, this study intends to develop a non-invasive evaluation model of CO based on wearable data, and optimize the parameters to realize the cardiac capacity detection function in resting and exercise states on the wearable device.

Interventions

OTHERExercise

Cardiac output (CO) was measured after exercise intervention in patients with normal cardiac function

Sponsors

Navy General Hospital, Beijing
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Over 18 years old * Left ventricular ejection fraction (Left ventricular ejection fraction, LVEF) \< 50%(200 subjects) * Left ventricular ejection fraction (Left ventricular ejection fraction, LVEF) ≥50% (100 subjects) * Able to use smart phones and operate wearable devices such as wristbands/watches

Exclusion criteria

* Patients with pacemaker implantation * No smartphone * Currently participating in other clinical trials * Lactating women * Pregnant Women * Unable to run and ride due to personal physical and external reasons (subjects participating in the exercise state cardiac output model study) * Physical examination results in the past year have clear cardiovascular, metabolic, bone and joint related diseases that have exercise risk, or have diseases and related potential health risks confirmed by the self-examination form of physical status before exercise (participants in the exercise state cardiac output model study) * No informed consent was obtained

Design outcomes

Primary

MeasureTime frameDescription
cardiac outputFrom enrollment to the end of follow-up at 1 monthTaking cardiac function indicators such as cardiac output by echocardiography as the gold standard, using wearable device monitoring data(Photoplethysmographic pulse wave), the resting state cardiac output artificial intelligence machine learning model was established, and the sensitivity, specificity, positive predictive value, negative predictive value, F1 score, diagnostic efficiency Area Under Curve (AUC), and the sensitivity, specificity, positive predictive value, negative predictive value, F1 score, diagnostic efficiency of the model were calculated. AUC), precision and precision-recall curves were used to evaluate the performance of the model.

Secondary

MeasureTime frameDescription
Heart failureFrom enrollment to the end of follow-up at 1 monthHeart failure symptoms, acute heart failure episodes, rehospitalization rates, and cardiovascular mortality

Contacts

Primary ContactYutao Guo
zhanghuiay08@sian.com+86 13683176151

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026