Prognostic model for long-term heart function after pulmonary embolism using ECG and biomarkers
Prognostic Model for Long-Term Cardiac Function After Pulmonary Embolism Based on Dynamic Electrocardial Signal and Circulating Biomarkers
This study is trying to see if a new method using heart signals and blood tests can help predict long-term heart problems in people who have had a pulmonary embolism.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | China-Japan Friendship Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06541353 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a prognostic model to predict long-term right ventricular dysfunction (RVD) in patients who have experienced acute pulmonary embolism (PE). It will involve the collection of ECG signals using a wearable device during hospitalization and follow-up for one year post-discharge. Blood and urine samples will also be collected to analyze biomarkers related to inflammation and cardiac function. The study will utilize artificial intelligence to identify patterns in the ECG data and biomarkers that may indicate the progression of RVD after PE.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of acute pulmonary embolism within the last 14 days.
Not a fit: Patients with a previous diagnosis of venous thromboembolism without recurrence or those unable to complete the follow-up may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a predictive tool for monitoring heart function in PE patients, potentially improving long-term outcomes.
How similar studies have performed: While studies have explored the use of AI and wearable devices in cardiac monitoring, this specific approach to predicting long-term RVD after PE is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 years; 2. Patients with confirmed diagnosis of PE (refer to the 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism); 3. Onset ≤14 days from diagnosis; (4) Risk stratification of intermediate-low risk, intermediate-high risk, and high-risk according to the 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism; 5\) Patients agree to sign informed consent. Exclusion Criteria: 1. A previous diagnosis of VTE with no evidence of recurrence, re-hospitalisation or treatment. 2. Unable to attach the cardiac acquisition system due to chest surgery, localised damage, allergy, etc. 3. Unable to complete the 1-year follow-up. 4. Unable to operate portable mapping due to cognitive impairment, lack of a smartphone, etc.
Where this trial is running
Beijing, Beijing Municipality
- China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Zhenguo Zhai, Ph.D — China-Japan Friendship Hospital
- Study coordinator: Zhenguo Zhai, Ph.D
- Email: zhaizhenguo2011@126.com
- Phone: 18611706133
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.