Artificial IntelligentAINCT04885088
Smart Home Care of Cloud Base ECG on the Cardiotoxicity Prevention on the Cancer Patients.
An observational study of Artificial Intelligent and Cardiotoxicity, run by Ju-Chi Liu.
Trial summary
Thoracic malignancy is the most commonly diagnosed cancer worldwide.1,2 The incidence of thoracic malignancy has decreased in North America, but not in Asia, where it continues to show an increasing trend. A notable manifestation of the bimodal age distribution of thoracic malignancy has been observed in women. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Artificial Intelligent, Cardiotoxicity, Cardiac Monitor
- What is being tested?
- Wisdom bracelet
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2021to 30 Jun 2023
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Age>=20,Physician diagnosed with Patients who had received radiotherapy (RT) or anthracycline-based CT or cancer immunotherapy or Targeted Therapy.
Who may be able to join
- ≥ 20-year-old
- Patients who had received radiotherapy (RT) or anthracycline-based CT or cancer immunotherapy or Targeted Therapy
- Diagnosis of Thoracic malignancy or breast cancer.
- Willing to sign the consent form of the subject and cooperate with the return visit
- Those who are admitted to the hospital and enter the general ward can receive the first ECG heart sound examination
Who cannot join
- <20-year-old
- Can't received radiotherapy (RT) or anthracycline-based CT or cancer immunotherapy or Targeted Therapy
- Those who cannot perform the first examination after being admitted to the hospital and entering the general ward
- It is impossible to measure the group of ECG and heart sounds. For example, when using Pacemaker, the ECG showed ventricular tachycardia (VT) and Dextrocardia on admission.
- Patients who are bedridden and have difficulty in cooperating with return visits
- Any subject that the physician believes is at high risk for future uncooperative tracking
- Direct participants in this program
Trial locations and contacts
No sites are listed yet.
About this study
Thoracic malignancy is the most commonly diagnosed cancer worldwide.1,2 The incidence of thoracic malignancy has decreased in North America, but not in Asia, where it continues to show an increasing trend. A notable manifestation of the bimodal age distribution of thoracic malignancy has been observed in women. The occurrence of early-onset thoracic malignancy in the Asian population is earlier than that in the Western population, resulting in a higher incidence of thoracic malignancy in young Asian women. Moreover, the late onset age distribution of patients with thoracic malignancy in Asia (40-50 years) is earlier than that in Western countries (60-70 years), peaking at the age of 45-50 years in most women. The age-specific incidence rates of thoracic malignancy increase sharply until the menopausal stage.
Cardiovascular morbidity is higher among women with thoracic malignancy involving the thorax who had received radiotherapy (RT) compared with those not involving the thorax but receiving the same treatment. Thus far, the risks and time to onset of cardiac complications have been unclear in both young and old women. The proportion of young women with thoracic malignancy is higher in Asia than in Western countries. Furthermore, whether Asian women with thoracic malignancy are susceptible to RT remains unclear.
Read more
Anthracyclines are important therapeutic agents for breast cancer. Anthracycline-based regimens have similar or improved outcomes relative to the standard treatment regimen of cyclophosphamide, methotrexate, and fluorouracil. However, cardiotoxicity is a long-term toxicity associated with these regimens. The combined use of adjuvant anthracycline-based chemotherapy (CT) and RT may result in high cardiotoxicity. Nonetheless, no clear information on the effects of this combined therapy on the time to onset of both cardiac complications and cardiotoxicity is available. Furthermore, whether the cardiotoxicity of adjuvant RT and anthracycline-based CT is associated with age and ethnicity in women with thoracic malignancy remains unclear.
Therefore, cardiovascular disease is undoubtedly one of the most challenging health problems in the world. More efforts are needed to prevent and better control of this disease. Our proposed monitoring program is to use AI to monitor the basal value variation of personalized cardiovascular disease in cancer patients before and after chemoradiation. In the first year, our team focused on cardiotoxicity associated with cardiovascular disease models and cancer treatments. In the second year, we will apply knowledge in a clinical setting and calculate the severity of cardiac toxicity and its incidence and time response after cancer treatment. In the third year, high-risk groups will be identified to provide preventive intervention to reduce the risk of cancer-treatment related cardiotoxicity.
Read the detailed description
This study is open, prospective study, multi-center, randomized controlled trial, unobtrusive research. This study is start on June 1 2021. And will include 400 patients who have just cardiotoxicity of adjuvant RT and anthracycline-based CT patients who diagnosis of Thoracic malignancy. And random allocation 200 experimental group (Non-invasive Wearable Device) and 200 control group (routine medical).
Ask whether the patients who meet the exclusion criteria are willing to participate in the screening (Screening), if they are willing to join and sign the consent of the subject, and after the patient's condition is stable, conduct an electrocardiogram (V0) before discharge from the hospital. On day 7 (±2 weeks), day 84 (±4 weeks), 168 days (±4 weeks), 252 days (±4 weeks), 336 days (±8 weeks) during routine clinical referral (V1-V5) Both are done once. The results of these two tests and other basic information of the patient, including Demography, Vital Signs, High, Weight, Medication, and European and Taiwan Cardiology Association recommended routine test results of high-risk patients, including Blood Chemistry Panel, NT-proBNP, Echocardiography, Myocardial Perfusion Scan, etc., will record the information of the logged-in subjects on the paper case report form. The CRF only displays the study number, and no subject is available. In addition to the examination of each return visit, the subjects also took the ECG bracelet home at the time of discharge (V0) and wore it every day. After the discharge, the ECG was measured every morning and evening, and their personal activity and sleep were collected. Relevant information. After the subject was discharged from the hospital, the subject tracked the date of all adverse events due to cardiovascular disease within one year, including: heart failure, restenosis due to blood vessel, and non-fatal myocardial infarction , To do blood vessel-related surgery again, and data on the occurrence of death.
- Conditions
- Artificial Intelligent, Cardiotoxicity, Cardiac Monitor, Cancer Treatment, ECG
- Being tested
- Wisdom bracelet
- Keywords
- Artificial Intelligent, cardiotoxicity, Cardiac monitor, cancer treatment, ECG
- Medical subject headings
- Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wisdom braceletDevice
Wisdom bracelet
| Study group | Role | What they receive |
|---|---|---|
| Interventions | Device: Wisdom bracelet
Other Names:
control group (routine medical) Receives: Device: Wisdom bracelet | |
| control | routine medical Non-invasive Wearable Device Receives: Device: Wisdom bracelet |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
death, divided into yes or no
Measured: Within a year
heart failure
Come back to the hospital for heart failure (Judged by the physician) after discharge, divided into yes or no
Measured: Within a year
Acute Coronary Syndrome, Coronary Artery Disease
Come back to the hospital for Acute Coronary Syndrome, Coronary Artery Disease (Judged by the physician) after discharge, divided into yes or no
Measured: Within a year
Myocarditis
Come back to the hospital for Myocarditis (Judged by the physician) after discharge, divided into yes or no
Measured: Within a year
Secondary outcomes (6)
Arrhythmia
Re-hospitalization for Arrhythmia (Judged by the physician) after discharge, divided into yes or no
Measured: Within a year
Valvular Heart Disease
Re-hospitalization for Valvular Heart Disease (Judged by the physician) after discharge, divided into yes or no
Measured: Within a year
Physician adjusts medicine
According to the medicine order issued by the doctor, if there is any adjustment of the medicine, make a record,divided into yes or no
Measured: Within a year
Physician arranges examination early
If the doctor has arranged to do Cardiac ultrasound or stress \& redistribution myocardial perfusion scan with SPECT During non-table period, divided into yes or no
Measured: Within a year
Compliance
Judged by the physician, when the patient returns to the consultation, the patient is asked about the compliance with the drug in the past, divided into yes or no
Measured: Within a year
Medical cost
The sum of all medical and health insurance expenses of the patient in the past year
Measured: Within a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start1 Jul 2021 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artificial IntelligentStudies of the same condition, open and under way.
- 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
- Ju-Chi Liu
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University WanFang Hospital, Taipei Medical University Hospital, Lotung Poh-Ai Hospital
- Responsible party
- Sponsor-investigator, Ju-Chi Liu, Taipei Medical University Shuang Ho Hospital
- Investigators
- Ju-Chi Liu, PHD, MD, Study chair, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885088
- Sponsor's protocol ID
- ShuangHoH
- Acronym
- AI
- Status last verified
- May 2021
- First submitted
- 9 May 2021
- Last updated
- 13 May 2021
- 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 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Home Care of Cloud Base ECG on the Cardiotoxicity Prevention on the Cancer Patients.
- ClinicalTrials.gov ID
- NCT04885088
- Acronym / sponsor ID
- AI / ShuangHoH
- Conditions
- Artificial Intelligent, Cardiotoxicity, Cardiac Monitor, Cancer Treatment, ECG
- Keywords
- Artificial Intelligent, cardiotoxicity, Cardiac monitor, cancer treatment, ECG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ju-Chi LiuUniversity, hospital or other
- Collaborators
- Taipei Medical University WanFang Hospital, Taipei Medical University Hospital, Lotung Poh-Ai Hospital
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 13 May 2021 (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.
Thoracic malignancy is the most commonly diagnosed cancer worldwide.1,2 The incidence of thoracic malignancy has decreased in North America, but not in Asia, where it continues to show an increasing trend. A notable manifestation of the bimodal age distribution of thoracic malignancy has been observed in women. The occurrence of early-onset thoracic malignancy in the Asian population is earlier than that in the Western population, resulting in a higher incidence of thoracic malignancy in young Asian women. Moreover, the late onset age distribution of patients with thoracic malignancy in Asia (40-50 years) is earlier than that in Western countries (60-70 years), peaking at the age of 45-50 years in most women. The age-specific incidence rates of thoracic malignancy increase sharply until the menopausal stage.
Cardiovascular morbidity is higher among women with thoracic malignancy involving the thorax who had received radiotherapy (RT) compared with those not involving the thorax but receiving the same treatment. Thus far, the risks and time to onset of cardiac complications have been unclear in both young and old women. The proportion of young women with thoracic malignancy is higher in Asia than in Western countries. Furthermore, whether Asian women with thoracic malignancy are susceptible to RT remains unclear.
Anthracyclines are important therapeutic agents for breast cancer. Anthracycline-based regimens have similar or improved outcomes relative to the standard treatment regimen of cyclophosphamide, methotrexate, and fluorouracil. However, cardiotoxicity is a long-term toxicity associated with these regimens. The combined use of adjuvant anthracycline-based chemotherapy (CT) and RT may result in high cardiotoxicity. Nonetheless, no clear information on the effects of this combined therapy on the time to onset of both cardiac complications and cardiotoxicity is available. Furthermore, whether the cardiotoxicity of adjuvant RT and anthracycline-based CT is associated with age and ethnicity in women with thoracic malignancy remains unclear.
Therefore, cardiovascular disease is undoubtedly one of the most challenging health problems in the world. More efforts are needed to prevent and better control of this disease. Our proposed monitoring program is to use AI to monitor the basal value variation of personalized cardiovascular disease in cancer patients before and after chemoradiation. In the first year, our team focused on cardiotoxicity associated with cardiovascular disease models and cancer treatments. In the second year, we will apply knowledge in a clinical setting and calculate the severity of cardiac toxicity and its incidence and time response after cancer treatment. In the third year, high-risk groups will be identified to provide preventive intervention to reduce the risk of cancer-treatment related cardiotoxicity.
Detailed description
This study is open, prospective study, multi-center, randomized controlled trial, unobtrusive research. This study is start on June 1 2021. And will include 400 patients who have just cardiotoxicity of adjuvant RT and anthracycline-based CT patients who diagnosis of Thoracic malignancy. And random allocation 200 experimental group (Non-invasive Wearable Device) and 200 control group (routine medical).
Ask whether the patients who meet the exclusion criteria are willing to participate in the screening (Screening), if they are willing to join and sign the consent of the subject, and after the patient's condition is stable, conduct an electrocardiogram (V0) before discharge from the hospital. On day 7 (±2 weeks), day 84 (±4 weeks), 168 days (±4 weeks), 252 days (±4 weeks), 336 days (±8 weeks) during routine clinical referral (V1-V5) Both are done once. The results of these two tests and other basic information of the patient, including Demography, Vital Signs, High, Weight, Medication, and European and Taiwan Cardiology Association recommended routine test results of high-risk patients, including Blood Chemistry Panel, NT-proBNP, Echocardiography, Myocardial Perfusion Scan, etc., will record the information of the logged-in subjects on the paper case report form. The CRF only displays the study number, and no subject is available. In addition to the examination of each return visit, the subjects also took the ECG bracelet home at the time of discharge (V0) and wore it every day. After the discharge, the ECG was measured every morning and evening, and their personal activity and sleep were collected. Relevant information. After the subject was discharged from the hospital, the subject tracked the date of all adverse events due to cardiovascular disease within one year, including: heart failure, restenosis due to blood vessel, and non-fatal myocardial infarction , To do blood vessel-related surgery again, and data on the occurrence of death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventions | – | Device: Wisdom braceletDevice: Wisdom bracelet Other Names: control group (routine medical) |
| control | – | Device: Wisdom braceletroutine medical Non-invasive Wearable Device |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Age>=20,Physician diagnosed with Patients who had received radiotherapy (RT) or anthracycline-based CT or cancer immunotherapy or Targeted Therapy.
Key inclusion criteria (5 listed)
- ≥ 20-year-old
- Patients who had received radiotherapy (RT) or anthracycline-based CT or cancer immunotherapy or Targeted Therapy
- Diagnosis of Thoracic malignancy or breast cancer.
- Willing to sign the consent form of the subject and cooperate with the return visit
- Those who are admitted to the hospital and enter the general ward can receive the first ECG heart sound examination
Key exclusion criteria (7 listed)
- <20-year-old
- Can't received radiotherapy (RT) or anthracycline-based CT or cancer immunotherapy or Targeted Therapy
- Those who cannot perform the first examination after being admitted to the hospital and entering the general ward
- It is impossible to measure the group of ECG and heart sounds. For example, when using Pacemaker, the ECG showed ventricular tachycardia (VT) and Dextrocardia on admission.
- Patients who are bedridden and have difficulty in cooperating with return visits
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 |
|---|---|---|
| Wisdom braceletWisdom bracelet | Device | Interventions, control |
Primary outcome
death
Time frame: Within a year
death, divided into yes or no
heart failure
Time frame: Within a year
Come back to the hospital for heart failure (Judged by the physician) after discharge, divided into yes or no
Acute Coronary Syndrome, Coronary Artery Disease
Time frame: Within a year
Come back to the hospital for Acute Coronary Syndrome, Coronary Artery Disease (Judged by the physician) after discharge, divided into yes or no
Myocarditis
Time frame: Within a year
Come back to the hospital for Myocarditis (Judged by the physician) after discharge, divided into yes or no
6 secondary outcomes
Arrhythmia
Time frame: Within a year
Valvular Heart Disease
Time frame: Within a year
Physician adjusts medicine
Time frame: Within a year
Physician arranges examination early
Time frame: Within a year
Compliance
Time frame: Within a year
Medical cost
Time frame: Within a year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Individual participant dataSharing planned: No
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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.
Ju-Chi Liu, PHD, MD study chair
Taipei Medical University Shuang Ho Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Artificial Intelligent and Cardiotoxicity, run by Ju-Chi Liu.
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 7 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 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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 YU ANN FANG, MS (886-2-22490088 ext. 8891, runawayyu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: Within a year). The study lists 4 primary outcomes in all. 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 May 2021.