Acute Coronary SyndromeNCT03738930
Effectiveness of Artificial Intelligent Based mHealth System to Reduce ACS Patients Bleeding Events After PCI
A study testing AI based mHealth system in people with Acute Coronary Syndrome and Percutaneous Coronary Intervention, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The present study was designed to observe the effectiveness of artificial intelligent based mHealth system(Chronic disease management system) to reduce bleeding events in ACS patients undergoing PCI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Percutaneous Coronary Intervention, Bleeding
- What is being tested?
- AI based mHealth system
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2018to 1 Jan 2020
- Phase
- Interventional
- 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
Who may be able to join
- age≥18 years, male or female; confirmed acute coronary syndrome patients; undergo percutaneous coronary intervention (PCI) treatment; good command of smart phones agree to participate in this clinical study and sign a written consent form.
Who cannot join
- ACS admission deemed secondary to other cause such as traffic accidents, trauma, severe upper gastrointestinal bleeding, surgery, or procedure; patients who are not intend to attend 1 year of follow-up study or investigators find that patients are not able to comply with the study's requirements; pregnant women or lactating women; investigators consider patients who were not suitable for participation with other reasons
Trial locations and contacts
1 site in 1 country.
Yundai Chen, Master contact
China1 site, 1 recruiting
- Recruiting
The General Hospital of PLA
Beijing, Beijing Municipality
Dandan Li, Master, +86 15711017209, cardio_lidandan@163.com
About this study
Official title: Effectiveness of Artificial Intelligent Based mHealth System(Chronic Disease Management System) to Reduce ACS Patients Bleeding Events After PCI: Parallel Randomized Controlled Trial
The present study was designed to observe the effectiveness of artificial intelligent based mHealth system(Chronic disease management system) to reduce bleeding events in ACS patients undergoing PCI.
- Being tested
- AI based mHealth system
- Keywords
- Acute Coronary Syndrome, Percutaneous coronary intervention, Bleeding
- Medical subject headings
- Acute Coronary Syndrome, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI based mHealth systemBehavioural
AI based mHealth system is used to deliver self-management contral message and health education message to make patients take notice of bleeding events after PCI.
| Study group | Role | What they receive |
|---|---|---|
| normal follow-up group | No intervention | normal follow-up in ACS patients after PCI |
| AI based mHealth system follow-up group | Experimental | AI based mHealth system follow-up in ACS patients after PCI. ACS patients in this group will receive message to take more notice to bleeding events. Receives: Behavioral: AI based mHealth system |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of major bleeding during each visit between normal group and smartphone based group
Bleeding definition：According to the bleeding Academic Research Congress (BARC) standard
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start10 Nov 2018 (estimated)
- Primary completion1 Apr 2019 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yun Dai Chen, Chinese PLA General Hospital
- Investigators
- Yundai Chen, Master, Principal investigator, The General Hospital of PLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738930
- Sponsor's protocol ID
- AI-mHealth-pilot
- Status last verified
- Nov 2018
- First submitted
- 8 Nov 2018
- Last updated
- 13 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Artificial Intelligent Based mHealth System(Chronic Disease Management System) to Reduce ACS Patients Bleeding Events After PCI: Parallel Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03738930
- Acronym / sponsor ID
- AI-mHealth-pilot
- Keywords
- Acute Coronary Syndrome, Percutaneous coronary intervention, Bleeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 10 Nov 2018 (estimated)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 13 Nov 2018 (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 present study was designed to observe the effectiveness of artificial intelligent based mHealth system(Chronic disease management system) to reduce bleeding events in ACS patients undergoing PCI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal follow-up group | No intervention | –normal follow-up in ACS patients after PCI |
| AI based mHealth system follow-up group | Experimental | Behavioral: AI based mHealth systemAI based mHealth system follow-up in ACS patients after PCI. ACS patients in this group will receive message to take more notice to bleeding events. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age≥18 years, male or female; confirmed acute coronary syndrome patients; undergo percutaneous coronary intervention (PCI) treatment; good command of smart phones agree to participate in this clinical study and sign a written consent form.
Key exclusion criteria (1 listed)
- ACS admission deemed secondary to other cause such as traffic accidents, trauma, severe upper gastrointestinal bleeding, surgery, or procedure; patients who are not intend to attend 1 year of follow-up study or investigators find that patients are not able to comply with the study's requirements; pregnant women or lactating women; investigators consider patients who were not suitable for participation with other reasons
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 |
|---|---|---|
| AI based mHealth systemAI based mHealth system is used to deliver self-management contral message and health education message to make patients take notice of bleeding events after PCI. | Behavioural | AI based mHealth system follow-up group |
Primary outcome
the incidence of major bleeding during each visit between normal group and smartphone based group
Time frame: 3 months
Bleeding definition：According to the bleeding Academic Research Congress (BARC) standard
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Yundai Chen, Master contact
Yundai Chen, Master principal investigator
The General Hospital of PLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI based mHealth system in people with Acute Coronary Syndrome and Percutaneous Coronary Intervention, run by Chinese PLA General 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Nov 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dandan Li, Master (+86 15711017209, cardio_lidandan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of major bleeding during each visit between normal group and smartphone based group (time frame: 3 months). 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 13 Nov 2018.