Clinical trial NCT04320134: cliNIcal sCEnarios and Pathophysiology of Atrial Fibrillation
Official title: CliNIcal SCEnarios and Pathophysiological Features of Patients With Atrial Fibrillation: a Long Term Prospective Study (NICE-AF Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
pathophysiology
triggers
substrates
autonomic system
Lead sponsor: Policlinico Casilino ASL RMB
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In this prospective observational study we consider to enroll patients with diagnosis of Atrial Fibrillation (new onset, paroxysmal, persistent, long-persistent and permanent) admitted to our Hospital in the Emergency Room and/or Cardiology Department/Ambulatory Care Center.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Atrial Fibrillation recurrences
timeFrame: 5 years
measure: Number of participants with Major Adverse Cardiac Events (MACE)
timeFrame: 5 years
measure: Rate of thromboembolic events
timeFrame: 5 years
measure: Rate of bleeding events
timeFrame: 5 years
Secondary outcomes:
measure: Rate of participants socio-demographic characteristics
timeFrame: baseline and 5 years
measure: Rate of participants with comorbidities
timeFrame: baseline and 5 years
measure: Rate of participants with Heart diseases
timeFrame: baseline and 5 years
measure: Rate of patients with Atrial Fibrillation secondary to triggers and/or autonomic system imbalance and/or modifiable factors
timeFrame: baseline and 5 years
measure: Describe imaging parameters (echocardiogram and cardiac magnetic resonance)
timeFrame: baseline and 5 years
measure: Concentration of laboratory biomarkers
timeFrame: baseline and 5 years
Other outcomes:
Locations:
Study officials:
References:
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citation: Rienstra M, Vermond RA, Crijns HJ, Tijssen JG, Van Gelder IC; RACE Investigators. Asymptomatic persistent atrial fibrillation and outcome: results of the RACE study. Heart Rhythm. 2014 Jun;11(6):939-45. doi: 10.1016/j.hrthm.2014.03.016. Epub 2014 Mar 13.
citation: Frykman V, Frick M, Jensen-Urstad M, Ostergren J, Rosenqvist M. Asymptomatic versus symptomatic persistent atrial fibrillation: clinical and noninvasive characteristics. J Intern Med. 2001 Nov;250(5):390-7. doi: 10.1046/j.1365-2796.2001.00893.x.
citation: Chung MK, Eckhardt LL, Chen LY, Ahmed HM, Gopinathannair R, Joglar JA, Noseworthy PA, Pack QR, Sanders P, Trulock KM; American Heart Association Electrocardiography and Arrhythmias Committee and Exercise, Cardiac Rehabilitation, and Secondary Prevention Committee of the Council on Clinical Cardiology; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular and Stroke Nursing; and Council on Lifestyle and Cardiometabolic Health. Lifestyle and Risk Factor Modification for Reduction of Atrial Fibrillation: A Scientific Statement From the American Heart Association. Circulation. 2020 Apr 21;141(16):e750-e772. doi: 10.1161/CIR.0000000000000748. Epub 2020 Mar 9.
citation: Slomski A. Alcohol Abstinence Lowers Atrial Fibrillation Recurrence Risk. JAMA. 2020 Feb 25;323(8):701. doi: 10.1001/jama.2020.1005. No abstract available.
citation: Stiell IG, Sivilotti MLA, Taljaard M, Birnie D, Vadeboncoeur A, Hohl CM, McRae AD, Rowe BH, Brison RJ, Thiruganasambandamoorthy V, Macle L, Borgundvaag B, Morris J, Mercier E, Clement CM, Brinkhurst J, Sheehan C, Brown E, Nemnom MJ, Wells GA, Perry JJ. Electrical versus pharmacological cardioversion for emergency department patients with acute atrial fibrillation (RAFF2): a partial factorial randomised trial. Lancet. 2020 Feb 1;395(10221):339-349. doi: 10.1016/S0140-6736(19)32994-0.