Clinical trial NCT05170607: Investigation of Specific Biomarkers in Patients With Atrial Fibrillation Who Undergo Interventional Treatment
Official title: Investigation of Specific Biomarkers in Patients With Atrial Fibrillation Who Undergo Interventional Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
protein microarray
proteomic biomarkers
PV dependent atrial fibrillation
Lead sponsor: National Medical Research Center for Therapy and Preventive Medicine
Sponsor class: OTHER_GOV
First posted: 2021-12-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18-85 years old with s paroxismal or persistant atrial fibrillation and prior interventional treatment

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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: proteins after validation
timeFrame: 1 year
Secondary outcomes:
measure: proteins after screening
timeFrame: 1 year
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: National Research Center for Preventive Medicine
Study officials:
References: