Acute Myocardial InfarctionNCT06995495
Wearable Devices Faciliate the Management of AMI Patients
An observational study of Acute Myocardial Infarction, run by RenJi Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myocardial Infarction
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 1 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are diagnosed with AMI, including ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI), and admitted to cardiac Cardiac Intensive Care Unit (CICU) after primary PCI.
Who may be able to join
- Aged 18-75 years old
- Diagnosed with STEMI or NSTEMI (ACC/AHA guidelines)
- Half male and half female
- Undergo CAG and PCI treatment;
- Written informed consent.
Who cannot join
- People under the age of 18 years old;
- Patients who are pregnant/breastfeeding;
- Patients who are allergic to the metallic or plastic components of the wearable devices
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, 200127
ZHIGUO ZOU, MD, PhD, +86 13524596108, zouzhiguo@renji.com
About this study
Official title: Wearable Device for Characterizing AMI Patients After Primary PCI and Predicting the Clinical Outcomes
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.
Read the 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.
- Conditions
- Acute Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Pattern assessed artificial intelligence (AI)-assisted analysis
The dynamic trajectory or trend of a patient's heart rate measurements over the course of hospital stay. Time series data will be analyzed by AI-assisted machine learning model.
Measured: Throughout the full course of hospitalization, with an average of 1 week.
Secondary outcomes (5)
Cardiac function assessed by echocardiography
Cadiac function is evaluated as left ventricular ejection fraction (LVEF, %) by echocardiography
Measured: At 1-month, 6-month and 1-year follow-ups.
The event rate of coronary revascularization
The proportion (%) of participants who undergo an unplanned coronary revascularization procedure-either percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
Measured: From date of enrollment until the date of follow-ups at 1-month, 6-month and 1-year post discharge.
The event rate of heart failure
The proportion (%) of participants who experience symptomatic heart failure. Heart failure is diagnosed based on symptoms such as shortness of breath and excess fluid, in the presence of a reduced LVEF (<60%) as assessed by echocardiography.
Measured: From date of enrollment until the date of follow-ups at 1-month, 6-month and 1-year post discharge.
The event rate of re-infarction
The proportion (%) of participants who experience recurrent myocardial infarction, refers to a new or additional heart attack that occurs after the myocardial infarction diagnosed at enrollment.
Measured: From date of enrollment until the date of follow-ups at 1-month, 6-month and 1-year post discharge.
Cardiovascular mortality (%)
Cardiovascular mortality (%) is defined as the proportion of participants who die due to cardiovascular causes during the follow-up period. Cardiovascular causes include myocardial infarction, heart failure, stroke, sudden cardiac death, or other documented cardiac or vascular events.
Measured: From date of enrollment until date of death from cardiovascular causes, or assessed up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Apr 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiguo Zou, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995495
- Sponsor's protocol ID
- EARLY-MYO Wearable Devices
- Status last verified
- May 2025
- First submitted
- 21 Jan 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Device for Characterizing AMI Patients After Primary PCI and Predicting the Clinical Outcomes
- ClinicalTrials.gov ID
- NCT06995495
- Acronym / sponsor ID
- EARLY-MYO Wearable Devices
- Conditions
- Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 29 May 2025 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are diagnosed with AMI, including ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI), and admitted to cardiac Cardiac Intensive Care Unit (CICU) after primary PCI.
Key inclusion criteria (5 listed)
- Aged 18-75 years old
- Diagnosed with STEMI or NSTEMI (ACC/AHA guidelines)
- Half male and half female
- Undergo CAG and PCI treatment;
- Written informed consent.
Key exclusion criteria (3 listed)
- People under the age of 18 years old;
- Patients who are pregnant/breastfeeding;
- Patients who are allergic to the metallic or plastic components of the wearable devices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Heart Rate Pattern assessed artificial intelligence (AI)-assisted analysis
Time frame: Throughout the full course of hospitalization, with an average of 1 week.
The dynamic trajectory or trend of a patient's heart rate measurements over the course of hospital stay. Time series data will be analyzed by AI-assisted machine learning model.
5 secondary outcomes
Cardiac function assessed by echocardiography
Time frame: At 1-month, 6-month and 1-year follow-ups.
The event rate of coronary revascularization
Time frame: From date of enrollment until the date of follow-ups at 1-month, 6-month and 1-year post discharge.
The event rate of heart failure
Time frame: From date of enrollment until the date of follow-ups at 1-month, 6-month and 1-year post discharge.
The event rate of re-infarction
Time frame: From date of enrollment until the date of follow-ups at 1-month, 6-month and 1-year post discharge.
Cardiovascular mortality (%)
Time frame: From date of enrollment until date of death from cardiovascular causes, or assessed up to 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
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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.
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 Acute Myocardial Infarction, run by RenJi Hospital 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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 29 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhiguo Zou, MD, PhD (+86 13524596108, zouzhiguo@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Pattern assessed artificial intelligence (AI)-assisted analysis (time frame: Throughout the full course of hospitalization, with an average of 1 week.). 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 29 May 2025.