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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05181774
Other study ID # AF and stroke 2
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 20, 2021
Est. completion date December 31, 2023

Study information

Verified date December 2021
Source First Affiliated Hospital of Harbin Medical University
Contact Haiyu Zhang, MD
Phone +8645185555009
Email zhanghaiyu819@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Objectives: Atrial fibrillation (AF) is the most common arrhythmia. Anticoagulation with warfarin or new oral anticoagulants in patients with AF can significantly reduce thromboembolic events. However, due to the lack of bleeding risk predictors of oral anticoagulants, the bleeding risk of patients with AF cannot be accurately evaluated. The purpose of this study is to screen biomarkers that can predict bleeding in patients with AF through proteomics and metabolomics, and construct the protein metabolic network pathway of anticoagulant bleeding in patients with AF. Design: AF patients treated with oral anticoagulants were enrolled in this study. Blood samples were centrifuged and the supernatant was stored in the refrigerator at - 80 ℃. All patients were followed up for one year to determine whether bleeding occurred after oral anticoagulants. Proteomic data were obtained by LC-MS/MS Analysis-DIA platform. Metabolomic data were obtained by UPLC-QTOF/MS platform. All of the omics data were used to compare proteins/enzymes with metabolic pathways. Quantitative changes of individual metabolites and proteins were calculated and graphed using the KEGG mapping tools.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age 18 years or above 2. Admission with atrial fibrillation or clinic visit for atrial fibrillation 3. Receive routine anticoagulant therapy; 4. Signing the consent form Exclusion Criteria: 1. Pregnant women; 2. Lactating women; 3. Severe mitral stenosis; 4. Severe impairment of liver function; 5. Severe renal insufficiency; 6. Thyroid dysfunction requiring treatment; 7. Have a history of severe bleeding within five years, such as intracerebral hemorrhage and gastrointestinal bleeding.

Study Design


Intervention

Diagnostic Test:
Proteomics
Proteomic data were obtained by LC-MS/MS Analysis-DIA platform.
Metabolomics
Metabolomic data were obtained by UPLC-QTOF/MS platform.

Locations

Country Name City State
China Yan Harbin Heilongjiang

Sponsors (1)

Lead Sponsor Collaborator
Yue LI

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Biomarkers predicting bleeding in AF patients through proteomics and metabolomics. Proteomic data were obtained by LC-MS/MS Analysis-DIA platform. Metabolomic data were obtained by UPLC-QTOF/MS platform. 1 year
Secondary Protein metabolic network pathway of anticoagulant bleeding in patients with AF. All of the omics data were used to compare proteins/enzymes with metabolic pathways. 1 year
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