Atrial FibrillationNCT05454878
Atrial Fibrillation Monitoring on Patients With Lymphoma After Chemotherapy
An observational study of Atrial Fibrillation, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This prospective cohort study is to investigate the incidence of atrial fibrillation after chemotherapy by aplying wearable ECG recoder and the risk factors on patients with newly diagonsed lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2022to 1 Dec 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 18 years and older
- All sexes
- Adult, Older adult
Study population: The new-onset lymphoma patient who was scheduled for chemotherapy
Who may be able to join
- At least 18 years old;
- Concurrent chemotherapy on patients with new-onset lymphoma: chemotherapy regimens containing anthracyclines;
- The subject voluntarily signed the informed consent.
Who cannot join
- With heart failure, acute stroke or acute coronary syndrome within 3 months before admission
- With Atrial fibrillation on admission
- Patient after pacemaker surgery
- With mental illness or mentally disabled
- Patients that the investigator considers as unsuitable for this test
Trial locations and contacts
1 site in 1 country.
China1 site
General hospital of PLA
Beijing, Beijing Municipality, 100853
Jingjing Wang
About this study
Official title: A Cohort Study of Atrial Fibrillation Monitoring on Patients With Lymphoma After Chemotherapy by Applying Wearable Electrocardiogram
This prospective cohort study is to investigate the incidence of atrial fibrillation after chemotherapy by aplying wearable ECG recoder and the risk factors on patients with newly diagonsed lymphoma
Read the detailed description
This prospective, single-centre, observational cohort study is disigned to enroll 100 newly diagnosed lymphoma patients who met the inclusion and exclusion criteria to monitor the onset of atrial fibrillation and other arrhythmias during chemotherapy by using wearable ECG recorder, and to evaluate the incidence of atrial fibrillation and related risk factors.
- Conditions
- Atrial Fibrillation
- Keywords
- lymphoma, chemotherapy, atrial fibrillation
- Medical subject headings
- Atrial Fibrillation, Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence
Incidence of atrial fibrillation after chemotherapy
Measured: 1 year after the first course of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start15 Jul 2022 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 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, MD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454878
- Sponsor's protocol ID
- LAF-20220523
- Status last verified
- Jun 2022
- First submitted
- 7 Jul 2022
- Last updated
- 12 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study of Atrial Fibrillation Monitoring on Patients With Lymphoma After Chemotherapy by Applying Wearable Electrocardiogram
- ClinicalTrials.gov ID
- NCT05454878
- Acronym / sponsor ID
- LAF-20220523
- Conditions
- Atrial Fibrillation
- Keywords
- lymphoma, chemotherapy, atrial fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 15 Jul 2022 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 12 Jul 2022 (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.
This prospective cohort study is to investigate the incidence of atrial fibrillation after chemotherapy by aplying wearable ECG recoder and the risk factors on patients with newly diagonsed lymphoma
Detailed description
This prospective, single-centre, observational cohort study is disigned to enroll 100 newly diagnosed lymphoma patients who met the inclusion and exclusion criteria to monitor the onset of atrial fibrillation and other arrhythmias during chemotherapy by using wearable ECG recorder, and to evaluate the incidence of atrial fibrillation and related risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The new-onset lymphoma patient who was scheduled for chemotherapy
Key inclusion criteria (3 listed)
- At least 18 years old;
- Concurrent chemotherapy on patients with new-onset lymphoma: chemotherapy regimens containing anthracyclines;
- The subject voluntarily signed the informed consent.
Key exclusion criteria (5 listed)
- With heart failure, acute stroke or acute coronary syndrome within 3 months before admission
- With Atrial fibrillation on admission
- Patient after pacemaker surgery
- With mental illness or mentally disabled
- Patients that the investigator considers as unsuitable for this test
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
Incidence
Time frame: 1 year after the first course of chemotherapy
Incidence of atrial fibrillation after chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
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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, MD principal investigator
Chinese PLA General Hospital
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 Atrial Fibrillation, 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 3 inclusion and 5 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 12 Jul 2022. 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 Yundai Chen (+86 01055499135, cyundai@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence (time frame: 1 year after the first course of chemotherapy). 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 12 Jul 2022.