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cliNIcal sCEnarios and Pathophysiology of Atrial Fibrillation

CliNIcal SCEnarios and Pathophysiological Features of Patients With Atrial Fibrillation: a Long Term Prospective Study (NICE-AF Study)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04320134
Acronym
NICE-AF
Enrollment
5000
Registered
2020-03-24
Start date
2020-04-15
Completion date
2025-04-15
Last updated
2020-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation, pathophysiology, triggers, substrates, autonomic system

Brief summary

Atrial fibrillation (AF) remains the most common sustained cardiac arrhythmia with prevalence and incidence continuously increasing worldwide. Current guidelines propose an etiological, symptom-based classification of the arrhythmia and mainly focused on its duration with consequent rhythm or rate-control strategies. Moreover, risk scores for atherothrombotic systemic or hemorrhagic events related to atrial fibrillation are principally based on patients cardiovascular history and risk factors. This approach do not consider relevant pathophysiological aspects that may play a pivotal role in triggering or perpetuating the arrhythmia, especially at its first occurrence. At this point, a crucial step would be deeply investigating AF clinical and pathophysiological features to guide a tailored diagnostical and therapeutic approach. Indeed, early recognition and proper characterization of triggers, substrates, autonomic system imbalance and modulating factors (drugs, electrolytes, etc) are of the utmost importance for AF care and management. Therefore, this large scale prospective observational study aims to evaluate clinical and pathophysiological features of patients with symptomatic and asymptomatic atrial fibrillation in different scenarios to understand possible distinctive characteristics warranting a personalized approach to the arrhythmia.

Interventions

None listed

Sponsors

Policlinico Casilino ASL RMB
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with electrocardiographic diagnosis of Atrial Fibrillation (New Onset, Paroxysmal, Persistent, Long Standing Persistent and Permanent) admitted to the Emergency Room and/or Cardiology Department /ambulatory care center of our Hospital * Age \>18 years old * Patients who can give their written informed consent.

Exclusion criteria

* Age \<18 years old * Patients who cannot give their written informed consent.

Design outcomes

Primary

MeasureTime frameDescription
Rate of Atrial Fibrillation recurrences5 yearsfrequency distribution
Number of participants with Major Adverse Cardiac Events (MACE)5 yearsfrequency distribution
Rate of thromboembolic events5 yearsfrequency distribution
Rate of bleeding events5 yearsfrequency distribution of minor, major and fatal bleedings

Secondary

MeasureTime frameDescription
Describe imaging parameters (echocardiogram and cardiac magnetic resonance)baseline and 5 yearsLeft ventricle, right ventricle, right and left atrium and valves: morphologies, volumes, dimensions and function
Rate of participants socio-demographic characteristicsbaseline and 5 yearsFrequency distribution: age, gender, race, occupation, life-style, diet, physical activity, alcohol consumption
Concentration of laboratory biomarkersbaseline and 5 yearsComplete Blood cell count with differential; Interleukin-1, Interleukin-6, High sensitivity C Reactive protein
Rate of participants with comorbiditiesbaseline and 5 yearsFrequency distribution: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia, lung diseases, thyroid disorders, gastrointestinal and liver disorders, hematological diseases, neoplasms, autoimmune disorders
Rate of participants with Heart diseasesbaseline and 5 yearsfrequency distribution: vascular diseases, valvular problems, cardiomyopathies, arrhythmias, family/genetic history of cardiovascular disease
Rate of patients with Atrial Fibrillation secondary to triggers and/or autonomic system imbalance and/or modifiable factorsbaseline and 5 yearsFrequency distribution of patients in which atrial fibrillation was clearly related to adrenergic tone imbalance and/or vagal tone imbalance and/or secondary to modifiable factors

Contacts

Primary ContactLeonardo Calò
leonardocalo.doc@gmail.com+390623188406
Backup ContactLeonardo Calò
+390623188406

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026