Prediction of Bleeding Risk After Anticoagulant Therapy for Atrial Fibrillation Based on Proteomics and Metabolomics

• Conditions: Bleeding; Atrial Fibrillation; Anticoagulant Therapy
• Interventions: Diagnostic Test: Proteomics; Diagnostic Test: Metabolomics

• Registration Number: NCT05181774
• Lead Sponsor: Yue LI

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-12
• Study Start: 2021-12-20
• Study First Submitted: 2021-12-20
• Study First Submitted QC: 2021-12-20
• Last Update Submitted: 2021-12-20
• Study First Posted: 2022-01-06
• Last Update Posted: 2022-01-06
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bleeding	Metabolomics	After one-year follow-up, AF patients with anticoagulation-related bleeding complications were enrolled in this group.
Non-bleeding	Proteomics	After one-year follow-up, AF patients without anticoagulation-related bleeding complications were enrolled in this group.
Non-bleeding	Metabolomics	After one-year follow-up, AF patients without anticoagulation-related bleeding complications were enrolled in this group.
Bleeding	Proteomics	After one-year follow-up, AF patients with anticoagulation-related bleeding complications were enrolled in this group.

Primary Outcome Measures

Name	Time	Method
Biomarkers predicting bleeding in AF patients through proteomics and metabolomics.	1 year	Proteomic data were obtained by LC-MS/MS Analysis-DIA platform. Metabolomic data were obtained by UPLC-QTOF/MS platform.

Secondary Outcome Measures

Name	Time	Method
Protein metabolic network pathway of anticoagulant bleeding in patients with AF.	1 year	All of the omics data were used to compare proteins/enzymes with metabolic pathways.

Trial Locations

Locations (1)

Yan; 🇨🇳 Harbin, Heilongjiang, China