Machine LearningNCT05905874
Machine Learning-based Models in Prediction of DVT and PTE in AECOPD Patients
An observational study of Machine Learning and Chronic Obstructive Pulmonary Disease, run by West China Hospital at 1 site in China.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is a common respiratory system disease characterized by persistent respiratory symptoms and irreversible airflow restriction, which seriously endangers people's health. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Machine Learning, Chronic Obstructive Pulmonary Disease, Chronic Obstructive Pulmonary Disease With Acute Exacerbation, Unspecified
- What is being tested?
- Machine learning-based prediction model
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2024
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The AECOPD patients since January 2015 to January 2022 from University of Chinese Academy of Sciences Shenzhen Hospital, Shenzhen, People's Republic of China \& The first Affiliated Hospital of Jinan University were assigned as the training set, and The AECOPD patients from Affiliated Hospital of North Sichuan Medical College and Nanchong Central Hospital during the same period were assigned as the validation sets.
Who may be able to join
- Diagnosis in accordance with AECOPD;
- Perform CT pulmonary angiography examination in present institutions;
- The relevant information to be analyzed is complete.
Who cannot join
- Patients who already had PTE before the diagnosis of AECOPD;
- Patients with concomitant bronchial asthma, interstitial lung disease, and other lung diseases;
- Patients with other thrombotic related diseases;
- Those who received anticoagulant treatment before enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
University of Chinese Academy of Sciences Shenzhen Hospital, Shenzhen, People's Republic of China & The first Affiliated Hospital of Jinan University
Shenzhen, Guangdong
Tao Wang, 8613258389788, wt20dy@163.com
About this study
Official title: Machine Learning-based Models in Prediction of DVT and PTE in AECOPD Patients: a Multi-institution Study
Chronic Obstructive Pulmonary Disease (COPD) is a common respiratory system disease characterized by persistent respiratory symptoms and irreversible airflow restriction, which seriously endangers people's health. Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) refers to individuals who experience continuous deterioration beyond their daily condition and need to change their routine medication. AECOPD is usually caused by viruses and bacteria, and patients require hospitalization, which brings a huge economic burden to society. AECOPD patients often have limited activities. Because long-term chronic hypoxia causes venous blood stasis, siltation causes secondary red blood cell increase, and blood hypercoagulability, AECOPD patients have a high risk of pulmonary embolism (PE).
Pulmonary Thrombo Embolism (PTE) refers to a disease caused by blockage of the pulmonary artery or its branches caused by a thrombus from the venous system or right heart. AECOPD patients experience elevated hemoglobin levels and increased blood viscosity due to long-term hypoxia. At the same time, such patients have decreased activity, venous congestion, and are prone to thrombosis. After the thrombus falls off, it can travel up the vein, causing PTE to occur in the right heart PTE is often secondary to low deep vein thrombosis (DVT). About 70% of patients were diagnosed as deep vein thrombosis in lower limb color ultrasound examination. SteinPD conducted a survey on COPD patients and general patients from multiple hospitals. The results showed that by comparing adult COPD patients with non COPD patients, the relative risk of DVT was 1.30, providing evidence for AECOPD being more likely to combine with PTE AECOPD patients with PTE have similarities in their clinical manifestations. It is difficult to distinguish between the two based solely on symptoms, such as cough, increased sputum production, increased shortness of breath, and difficulty breathing. They lack specificity and are difficult to distinguish between the two based solely on symptoms, which can easily lead to missed diagnosis. CT pulmonary angiography (CTPA) is the gold standard for the diagnosis of PTE, but due to the high cost of testing and high equipment prices, its popularity in grassroots hospitals is not high. Therefore, analyzing the risk factors of AECOPD patients complicated with PTE is of great significance for early identification of PTE. At present, although there are reports on the risk factors for concurrent PTE in AECOPD patients, there is no specific predictive model for predicting PTE in AECOPD patients. In clinical practice, risk assessment tools such as the Caprini risk assessment model and the modified Geneva scale are commonly used for VTE, while the Wells score is the PTE diagnostic likelihood score. The evaluation indicators of these tools are mostly clinical symptoms, and laboratory indicators are less involved, It is difficult to comprehensively reflect the patient's condition, so the specificity of AECOPD patients with PTE is not strong.
The column chart model established in this study presents a visual prediction model, which is convenient for clinical use and has positive help for the early detection of AECOPD patients with PTE. In addition, medical staff can present the calculation results of the column chart model to patients, making it easier for patients to understand. It helps improve the early identification and treatment of AECOPD combined with PTE patients, thereby improving prognosis.
- Conditions
- Machine Learning, Chronic Obstructive Pulmonary Disease, Chronic Obstructive Pulmonary Disease With Acute Exacerbation, Unspecified, Pulmonary Thromboembolisms, Deep Vein Thrombosis
- Being tested
- Machine learning-based prediction model
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Pulmonary Embolism, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Machine learning-based prediction modelOther
The machine learning-based prediction model will be used to forecast whether the presence of DVT and/or PTE or not in AECOPD patients after standardized treatment.
| Study group | Role | What they receive |
|---|---|---|
| AECOPD patients present with DVT and/or PTE | Not described Receives: Other: Machine learning-based prediction model | |
| AECOPD patients absent with DVT and/or PTE | Not described Receives: Other: Machine learning-based prediction model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients present with DVT and/or PTE
Number of patients present with DVT and/or PTE
Measured: 1 year
Secondary outcomes (2)
In-hospital mortality
The occurrence of death due to AECOPD or DVT/PTE
Measured: 1 year
ICU admission
Patients admitted to ICU due to AECOPD severity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Machine LearningStudies of the same condition, open and under way.
- More trials run by West China 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
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Hospital (Guangming), University of Chinese Academy of Sciences, Affiliated Hospital of North Sichuan Medical College, Nanchong Central Hospital
- Responsible party
- Principal investigator, Yuhan Yang, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905874
- Sponsor's protocol ID
- LL-KT-2023018
- Status last verified
- Jun 2023
- First submitted
- 9 May 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- 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 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Machine Learning-based Models in Prediction of DVT and PTE in AECOPD Patients: a Multi-institution Study
- ClinicalTrials.gov ID
- NCT05905874
- Acronym / sponsor ID
- LL-KT-2023018
- Conditions
- Machine Learning, Chronic Obstructive Pulmonary Disease, Chronic Obstructive Pulmonary Disease With Acute Exacerbation, Unspecified, Pulmonary Thromboembolisms, Deep Vein Thrombosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- Shenzhen Hospital (Guangming), University of Chinese Academy of Sciences, Affiliated Hospital of North Sichuan Medical College, Nanchong Central Hospital
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Jun 2023 (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.
Chronic Obstructive Pulmonary Disease (COPD) is a common respiratory system disease characterized by persistent respiratory symptoms and irreversible airflow restriction, which seriously endangers people's health. Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) refers to individuals who experience continuous deterioration beyond their daily condition and need to change their routine medication. AECOPD is usually caused by viruses and bacteria, and patients require hospitalization, which brings a huge economic burden to society. AECOPD patients often have limited activities. Because long-term chronic hypoxia causes venous blood stasis, siltation causes secondary red blood cell increase, and blood hypercoagulability, AECOPD patients have a high risk of pulmonary embolism (PE).
Pulmonary Thrombo Embolism (PTE) refers to a disease caused by blockage of the pulmonary artery or its branches caused by a thrombus from the venous system or right heart. AECOPD patients experience elevated hemoglobin levels and increased blood viscosity due to long-term hypoxia. At the same time, such patients have decreased activity, venous congestion, and are prone to thrombosis. After the thrombus falls off, it can travel up the vein, causing PTE to occur in the right heart PTE is often secondary to low deep vein thrombosis (DVT). About 70% of patients were diagnosed as deep vein thrombosis in lower limb color ultrasound examination. SteinPD conducted a survey on COPD patients and general patients from multiple hospitals. The results showed that by comparing adult COPD patients with non COPD patients, the relative risk of DVT was 1.30, providing evidence for AECOPD being more likely to combine with PTE AECOPD patients with PTE have similarities in their clinical manifestations. It is difficult to distinguish between the two based solely on symptoms, such as cough, increased sputum production, increased shortness of breath, and difficulty breathing. They lack specificity and are difficult to distinguish between the two based solely on symptoms, which can easily lead to missed diagnosis. CT pulmonary angiography (CTPA) is the gold standard for the diagnosis of PTE, but due to the high cost of testing and high equipment prices, its popularity in grassroots hospitals is not high. Therefore, analyzing the risk factors of AECOPD patients complicated with PTE is of great significance for early identification of PTE. At present, although there are reports on the risk factors for concurrent PTE in AECOPD patients, there is no specific predictive model for predicting PTE in AECOPD patients. In clinical practice, risk assessment tools such as the Caprini risk assessment model and the modified Geneva scale are commonly used for VTE, while the Wells score is the PTE diagnostic likelihood score. The evaluation indicators of these tools are mostly clinical symptoms, and laboratory indicators are less involved, It is difficult to comprehensively reflect the patient's condition, so the specificity of AECOPD patients with PTE is not strong.
The column chart model established in this study presents a visual prediction model, which is convenient for clinical use and has positive help for the early detection of AECOPD patients with PTE. In addition, medical staff can present the calculation results of the column chart model to patients, making it easier for patients to understand. It helps improve the early identification and treatment of AECOPD combined with PTE patients, thereby improving prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AECOPD patients present with DVT and/or PTE | – | Other: Machine learning-based prediction model |
| AECOPD patients absent with DVT and/or PTE | – | Other: Machine learning-based prediction model |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The AECOPD patients since January 2015 to January 2022 from University of Chinese Academy of Sciences Shenzhen Hospital, Shenzhen, People's Republic of China \& The first Affiliated Hospital of Jinan University were assigned as the training set, and The AECOPD patients from Affiliated Hospital of North Sichuan Medical College and Nanchong Central Hospital during the same period were assigned as the validation sets.
Key inclusion criteria (3 listed)
- Diagnosis in accordance with AECOPD;
- Perform CT pulmonary angiography examination in present institutions;
- The relevant information to be analyzed is complete.
Key exclusion criteria (4 listed)
- Patients who already had PTE before the diagnosis of AECOPD;
- Patients with concomitant bronchial asthma, interstitial lung disease, and other lung diseases;
- Patients with other thrombotic related diseases;
- Those who received anticoagulant treatment before enrollment.
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 |
|---|---|---|
| Machine learning-based prediction modelThe machine learning-based prediction model will be used to forecast whether the presence of DVT and/or PTE or not in AECOPD patients after standardized treatment. | Other | AECOPD patients absent with DVT and/or PTE, AECOPD patients present with DVT and/or PTE |
Primary outcome
Number of patients present with DVT and/or PTE
Time frame: 1 year
Number of patients present with DVT and/or PTE
2 secondary outcomes
In-hospital mortality
Time frame: 1 year
ICU admission
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- 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.
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 Machine Learning and Chronic Obstructive Pulmonary Disease, run by West China 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 3 inclusion and 4 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 15 Jun 2023. 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 Tao Wang (+8613456902508, wt20dy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients present with DVT and/or PTE (time frame: 1 year). 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 15 Jun 2023.