Investigation of Specific Biomarkers in Patients With Atrial Fibrillation Who Undergo Interventional Treatment

NCT05170607 | Unknown

• 1 other identifier: 121122200154-7
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The two main mechanisms for atrial fibrillation (AF) recurrence after cryoablation include Pulmonary vein (PV) reconnection and the presence of non-PV associated arrhythmic focuses. The aim of this study is to reveal the specific biomarkers by antibody microarrays.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; protein microarray; proteomic biomarkers; PV dependent atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• proteins after validation

  number of protein which will be specific for non-PV associated arrhythmic focuses group after validation

  1 year

Secondary Outcomes (1)

• proteins after screening

  1 year

Study Arms (3)

PV associated atrial fibrillation

Diagnostic Test: Proteomic analysis by antibody microarrays

non-PV associated arrhythmic focuses

Diagnostic Test: Proteomic analysis by antibody microarrays

Healthy volunteers

Diagnostic Test: Proteomic analysis by antibody microarrays

Interventions

Proteomic analysis by antibody microarrays DIAGNOSTIC_TEST

Proteomic analysis by antibody microarrays can be used to identify novel biomarkers and to investigate various signaling pathways including protein phosphorylation and protein-protein interactions. Microchips are manufactured as a matrix of a number of immobilized antibodies covalently bound to the glass, membrane, or gel surfaces. Microchips are used for serum proteomic studies in patients with cardiovascular diseases and cancer

Healthy volunteers; PV associated atrial fibrillation; non-PV associated arrhythmic focuses

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 18-85 years old with s paroxismal or persistant atrial fibrillation and prior interventional treatment

You may qualify if:

• Patient with paroxysmal/persistent atrial fibrillation who underwent interventional treatment

You may not qualify if:

• permanent AF
• contraindications to oral anticoagulation or heparin
• chronic kidney disease requiring dialysis
• untreated hypo- or hyperthyroidism
• breast feeding
• pregnancy
• chronic kidney disease requiring dialysis
• decompensated heart failure
• stroke within the last 3 months
• myocardial infarction within the last 3 months
• Percutaneous coronary intervention or Coronary Artery Bypass Grafting within the last 3 months
• active myocarditis
• artificial valve replacement surgery
• severe mitral or aortic stenosis
• coronary artery disease requiring revascularization

Sponsors & Collaborators

• National Medical Research Center for Therapy and Preventive Medicine: lead

Study Sites (1)

National Research Center for Preventive Medicine

Moscow, 101990, Russia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: December 28, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

RU (1)