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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Bleeding; Anticoagulant Therapy
• Intervention / Treatment: Diagnostic test: Proteomics; Diagnostic test: Metabolomics

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Haiyu Zhang, MD; Phone Number: +8645185555009; Email: zhanghaiyu819@163.com

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • Recruiting
      • Yan
      • Contact: Yan Shi, MD; Phone Number: +8645185555671; Email: yidashijing@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bleeding; After one-year follow-up, AF patients with anticoagulation-related bleeding complications were enrolled in this group.	Diagnostic test: Proteomics; Proteomic data were obtained by LC-MS/MS Analysis-DIA platform.; Diagnostic test: Metabolomics; Metabolomic data were obtained by UPLC-QTOF/MS platform.
Non-bleeding; After one-year follow-up, AF patients without anticoagulation-related bleeding complications were enrolled in this group.	Diagnostic test: Proteomics; Proteomic data were obtained by LC-MS/MS Analysis-DIA platform.; Diagnostic test: Metabolomics; Metabolomic data were obtained by UPLC-QTOF/MS platform.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yue LI

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): January 6, 2022

Study Record Updates

• Last Update Posted (Actual): January 6, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Bleeding; Anticoagulant therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Hemorrhage
• Other Study ID Numbers: AF and stroke 2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No