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

NCT ID: NCT05181774

Last Updated: 2022-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-20

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Atrial Fibrillation Bleeding Anticoagulant Therapy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Bleeding

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

Proteomics

Intervention Type DIAGNOSTIC_TEST

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

Metabolomics

Intervention Type DIAGNOSTIC_TEST

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.

Proteomics

Intervention Type DIAGNOSTIC_TEST

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

Metabolomics

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Proteomics

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

Intervention Type DIAGNOSTIC_TEST

Metabolomics

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yue LI

OTHER

Sponsor Role lead

Responsible Party

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Yue LI

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Yan

Harbin, Heilongjiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Haiyu Zhang, MD

Role: CONTACT

+8645185555009

Facility Contacts

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Yan Shi, MD

Role: primary

+8645185555671

Other Identifiers

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AF and stroke 2

Identifier Type: -

Identifier Source: org_study_id

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