- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05454878
Atrial Fibrillation Monitoring on Patients With Lymphoma After Chemotherapy
July 7, 2022 updated by: Yun Dai Chen, Chinese PLA General Hospital
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
Study Overview
Status
Not yet recruiting
Conditions
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 Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yundai Chen
- Phone Number: +86 01055499135
- Email: cyundai@vip.163.com
Study Locations
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Beijing
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Beijing, Beijing, China, 100853
- General Hospital of PLA
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Contact:
- Jingjing Wang
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The new-onset lymphoma patient who was scheduled for chemotherapy
Description
Inclusion Criteria:
- At least 18 years old;
- Concurrent chemotherapy on patients with new-onset lymphoma: chemotherapy regimens containing anthracyclines;
- The subject voluntarily signed the informed consent.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence
Time Frame: 1 year after the first course of chemotherapy
|
Incidence of atrial fibrillation after chemotherapy
|
1 year after the first course of chemotherapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 15, 2022
Primary Completion (Anticipated)
July 1, 2023
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
July 7, 2022
First Submitted That Met QC Criteria
July 7, 2022
First Posted (Actual)
July 12, 2022
Study Record Updates
Last Update Posted (Actual)
July 12, 2022
Last Update Submitted That Met QC Criteria
July 7, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LAF-20220523
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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