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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05170607
• Other study ID #: 121122200154-7
• Status: Active, not recruiting
• Start date: January 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: National Medical Research Center for Therapy and Preventive Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

One hundred twenty patients with atrial fibrillation will participate in the study.

They will be divided into three groups.

1. Patients with AF recurrence after the first procedure but with isolated pulmonary veins at the beginning of the second AF ablation b)patients with AF recurrence after repeat PV ablation.

2. Patients with PV-associated atrial fibrillation. The group will be included patients with freedom of atrial fibrillation after PV isolation (first or repeat procedure).

3. Healthy volunteers

Groups would be formed from patients who previously underwent atrial fibrillation ablations and whose blood samples have been taken and placed in a biobank before interventional treatment. The first step will include proteomic serum profiling using antibody microarrays in ten subjects will be split into 3 groups. The second step will include validation of selected protein biomarkers, in the total cohort (N=120).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

• heart transplant

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Diagnostic Test:
• Proteomic analysis by antibody microarrays
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

Locations

Country	Name	City	State
Russian Federation	National Research Center for Preventive Medicine	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
National Medical Research Center for Therapy and Preventive Medicine

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proteins after validation	number of protein which will be specific for non-PV associated arrhythmic focuses group after validation	1 year
Secondary	proteins after screening	number of protein which will be specific for non-PV associated arrhythmic focuses group after screening	1 year