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

NCT05181774 | Unknown

• 1 other identifier: AF and stroke 2
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Bleeding; Anticoagulant Therapy

Keywords

Atrial Fibrillation; Bleeding; Anticoagulant therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Protein metabolic network pathway of anticoagulant bleeding in patients with AF.

  1 year

Study Arms (2)

Bleeding

After one-year follow-up, AF patients with anticoagulation-related bleeding complications were enrolled in this group.

Diagnostic Test: Proteomics; Diagnostic Test: Metabolomics

Non-bleeding

After one-year follow-up, AF patients without anticoagulation-related bleeding complications were enrolled in this group.

Diagnostic Test: Proteomics; Diagnostic Test: Metabolomics

Interventions

Proteomics DIAGNOSTIC_TEST

Proteomic data were obtained by LC-MS/MS Analysis-DIA platform.

Bleeding; Non-bleeding

Metabolomics DIAGNOSTIC_TEST

Metabolomic data were obtained by UPLC-QTOF/MS platform.

Bleeding; Non-bleeding

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age 18 years or above
• Admission with atrial fibrillation or clinic visit for atrial fibrillation
• Receive routine anticoagulant therapy;
• Signing the consent form

You may not qualify if:

• Pregnant women;
• Lactating women;
• Severe mitral stenosis;
• Severe impairment of liver function;
• Severe renal insufficiency;
• Thyroid dysfunction requiring treatment;
• Have a history of severe bleeding within five years, such as intracerebral hemorrhage and gastrointestinal bleeding.

Sponsors & Collaborators

• Yue LI: lead

Study Sites (1)

Yan

Harbin, Heilongjiang, 150001, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Hemorrhage

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Haiyu Zhang, MD

CONTACT

+8645185555009; zhanghaiyu819@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 6, 2022
• Study Start: December 20, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 6, 2022

Record last verified: 2021-12

Locations

CN (1)