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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05181774
• Other study ID #: AF and stroke 2
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Anticoagulant Therapy
• Atrial Fibrillation
• Bleeding
• Hemorrhage

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