Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-31 @ 4:42 AM
Study NCT ID:
NCT06995495
Status:
RECRUITING
Last Update Posted:
2025-05-29
First Post:
2025-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wearable Devices Faciliate the Management of AMI Patients
Sponsor:
RenJi Hospital
Organization:
Study Overview
Official Title:
Wearable Device for Characterizing AMI Patients After Primary PCI and Predicting the Clinical Outcomes
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will explore the use of wearable technology to consistently monitor patients with acute myocardial infarction (AMI) receiving primary percutaneous coronary intervention (PCI). Parameters such as heart rate, sleep time, physical activity, and blood pressure will be collected and analyzed to characterize the patients and predict clinical outcomes.
Detailed Description:
The aim of this study is to explore in-hospital patient management and predict clinical outcomes in AMI patients receiving primary PCI through wearable technology (e.g., smart watches and wristband devices). The investigators expect to involve patients diagnosed with AMI, including ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI), who are admitted to the cardiac Cardiac Intensive Care Unit (CICU) after primary PCI.
With written consent, eligible participants will be consistently monitored by a wearable device during the CICU stay, in addition to a conventional monitoring system. Vital signs including heart rate (beats/minute), oxygen saturation (%) blood pressure (mmHg), and other crucial parameters such as sleep patterns will be recorded. The collected data will be analyzed using AI-assisted and machine learning techniques, integrated with other clinical data to construct models that support risk stratification, guide clinical decision-making, improve the quality of nursing care, and predict long-term prognosis for these patients. Serial follow-ups (6-month, annual, and long-term) will be performed, and important information such as cardiac function assessed by echocardiography, the incidence of major adverse cardiovascular events, and life qualities will be collected for each follow-up.
With written consent, eligible participants will be consistently monitored by a wearable device during the CICU stay, in addition to a conventional monitoring system. Vital signs including heart rate (beats/minute), oxygen saturation (%) blood pressure (mmHg), and other crucial parameters such as sleep patterns will be recorded. The collected data will be analyzed using AI-assisted and machine learning techniques, integrated with other clinical data to construct models that support risk stratification, guide clinical decision-making, improve the quality of nursing care, and predict long-term prognosis for these patients. Serial follow-ups (6-month, annual, and long-term) will be performed, and important information such as cardiac function assessed by echocardiography, the incidence of major adverse cardiovascular events, and life qualities will be collected for each follow-up.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: