cliNIcal sCEnarios and Pathophysiology of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— NICE-AF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04320134
• Other study ID #: PoliclinicoCasilino1-2020
• Status: Not yet recruiting
• Start date: April 15, 2020
• Est. completion date: April 15, 2025

Study information

• Verified date: March 2020
• Source: Policlinico Casilino ASL RMB
• Contact: Leonardo Calò
• Phone: +390623188406
• Email: leonardocalo.doc[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: April 15, 2025
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Policlinico Casilino ASL RMB

References & Publications (8)

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 Mar 9:CIR0000000000000748. doi: 10.1161/CIR.0000000000000748. [Epub ahead of print] — View Citation

Curtis AB, Gersh BJ, Corley SD, DiMarco JP, Domanski MJ, Geller N, Greene HL, Kellen JC, Mickel M, Nelson JD, Rosenberg Y, Schron E, Shemanski L, Waldo AL, Wyse DG; AFFIRM Investigators. Clinical factors that influence response to treatment strategies in atrial fibrillation: the Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) study. Am Heart J. 2005 Apr;149(4):645-9. — View 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. — View Citation

Heijman J, Guichard JB, Dobrev D, Nattel S. Translational Challenges in Atrial Fibrillation. Circ Res. 2018 Mar 2;122(5):752-773. doi: 10.1161/CIRCRESAHA.117.311081. Review. — View 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. — View Citation

Siontis KC, Gersh BJ, Killian JM, Noseworthy PA, McCabe P, Weston SA, Roger VL, Chamberlain AM. Typical, atypical, and asymptomatic presentations of new-onset atrial fibrillation in the community: Characteristics and prognostic implications. Heart Rhythm. 2016 Jul;13(7):1418-24. doi: 10.1016/j.hrthm.2016.03.003. Epub 2016 Mar 4. — View Citation

Slomski A. Alcohol Abstinence Lowers Atrial Fibrillation Recurrence Risk. JAMA. 2020 Feb 25;323(8):701. doi: 10.1001/jama.2020.1005. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Atrial Fibrillation recurrences	frequency distribution	5 years
Primary	Number of participants with Major Adverse Cardiac Events (MACE)	frequency distribution	5 years
Primary	Rate of thromboembolic events	frequency distribution	5 years
Primary	Rate of bleeding events	frequency distribution of minor, major and fatal bleedings	5 years
Secondary	Rate of participants socio-demographic characteristics	Frequency distribution: age, gender, race, occupation, life-style, diet, physical activity, alcohol consumption	baseline and 5 years
Secondary	Rate of participants with comorbidities	Frequency distribution: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia, lung diseases, thyroid disorders, gastrointestinal and liver disorders, hematological diseases, neoplasms, autoimmune disorders	baseline and 5 years
Secondary	Rate of participants with Heart diseases	frequency distribution: vascular diseases, valvular problems, cardiomyopathies, arrhythmias, family/genetic history of cardiovascular disease	baseline and 5 years
Secondary	Rate of patients with Atrial Fibrillation secondary to triggers and/or autonomic system imbalance and/or modifiable factors	Frequency 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	baseline and 5 years
Secondary	Describe imaging parameters (echocardiogram and cardiac magnetic resonance)	Left ventricle, right ventricle, right and left atrium and valves: morphologies, volumes, dimensions and function	baseline and 5 years
Secondary	Concentration of laboratory biomarkers	Complete Blood cell count with differential; Interleukin-1, Interleukin-6, High sensitivity C Reactive protein	baseline and 5 years