cliNIcal sCEnarios and Pathophysiology of Atrial Fibrillation

NCT04320134 | Unknown

• 1 other identifier: PoliclinicoCasilino1-2020
• Study Type: observational
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; pathophysiology; triggers; substrates; autonomic system

Outcome Measures

Primary Outcomes (4)

• Rate of Atrial Fibrillation recurrences

  frequency distribution

  5 years

• Number of participants with Major Adverse Cardiac Events (MACE)

  frequency distribution

  5 years

• Rate of thromboembolic events

  frequency distribution

  5 years

• Rate of bleeding events

  frequency distribution of minor, major and fatal bleedings

  5 years

Secondary Outcomes (6)

• Rate of participants socio-demographic characteristics

  baseline and 5 years

• Rate of participants with comorbidities

  baseline and 5 years

• Rate of participants with Heart diseases

  baseline and 5 years

• Rate of patients with Atrial Fibrillation secondary to triggers and/or autonomic system imbalance and/or modifiable factors

  baseline and 5 years

• Describe imaging parameters (echocardiogram and cardiac magnetic resonance)

  baseline and 5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Policlinico Casilino ASL RMB: lead

Related Publications (8)

• 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. doi: 10.1016/j.ahj.2004.09.038.

  PMID: 15990747 BACKGROUND

• 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.

  PMID: 26961300 BACKGROUND

• 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.

  PMID: 29496798 BACKGROUND

• 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.

  PMID: 24632222 BACKGROUND

• 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.

  PMID: 11887973 BACKGROUND

• 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.

  PMID: 32148086 BACKGROUND

• 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.

  PMID: 32096848 BACKGROUND

• 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.

  PMID: 32007169 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Leonardo Calò

CONTACT

+390623188406; leonardocalo.doc@gmail.com

Leonardo Calò

CONTACT

+390623188406

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, FESC

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: March 24, 2020
• Study Start: April 15, 2020
• Primary Completion: April 15, 2022
• Study Completion: April 15, 2025
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share