NCT05181787

Brief Summary

Thrombus shedding in patients with atrial fibrillation (AF) can lead to cerebral artery embolism. Stroke caused by AF is very dangerous, which not only threatens the life of patients, but also seriously affects the quality of life. This study aims to explore the biomarkers of stroke in patients with AF by integrating proteomics and metabolomics data, and establish the network relationship of stroke in patients with AF, so as to reveal the molecular mechanism of stroke in patients with AF.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

December 20, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

2 years

First QC Date

December 20, 2021

Last Update Submit

January 8, 2022

Conditions

Keywords

Atrial FibrillationStrokemetabolomicsproteomicsBiomarkers

Outcome Measures

Primary Outcomes (1)

  • Biomarkers of atrial fibrillation complicated with stroke based on proteomics and metabolomics

    By combining proteomics and metabolomics data, the investigators were able to identify the common pathways involved in AF with stroke.

    1 day

Secondary Outcomes (3)

  • Quantitative changes of individual metabolites and proteins were calculated and graphed using the KEGG mapping tools.

    1 day

  • By combining proteomics and metabolomics data, the investigators were able to identify the common pathways involved in AF with stroke.

    1 day

  • All of the omics data were used to compare proteins/enzymes with metabolic pathways.

    1 day

Study Arms (2)

AF

Patients with AF

Diagnostic Test: ProteomicsDiagnostic Test: Metabolomics

AF and stroke

Patients with AF complicated with stroke

Diagnostic Test: ProteomicsDiagnostic Test: Metabolomics

Interventions

ProteomicsDIAGNOSTIC_TEST

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

AFAF and stroke
MetabolomicsDIAGNOSTIC_TEST

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

AFAF and stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The blood samples of patients with AF and patients with AF complicated with stroke were taken. The supernatant was centrifuged and put into - 80 ℃ refrigerator for storage.

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yan

Harbin, Heilongjiang, 150001, China

RECRUITING

MeSH Terms

Conditions

Atrial FibrillationStroke

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
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 25, 2022

Record last verified: 2022-01

Locations