cliNIcal sCEnarios and Pathophysiology of Atrial Fibrillation (NICE-AF)

March 22, 2020 updated by: Leonardo Calò, MD, Policlinico Casilino ASL RMB

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Leonardo Calò
  • Phone Number: +390623188406

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Atrial Fibrillation recurrences
Time Frame: 5 years
frequency distribution
5 years
Number of participants with Major Adverse Cardiac Events (MACE)
Time Frame: 5 years
frequency distribution
5 years
Rate of thromboembolic events
Time Frame: 5 years
frequency distribution
5 years
Rate of bleeding events
Time Frame: 5 years
frequency distribution of minor, major and fatal bleedings
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of participants socio-demographic characteristics
Time Frame: baseline and 5 years
Frequency distribution: age, gender, race, occupation, life-style, diet, physical activity, alcohol consumption
baseline and 5 years
Rate of participants with comorbidities
Time Frame: baseline and 5 years
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
Rate of participants with Heart diseases
Time Frame: baseline and 5 years
frequency distribution: vascular diseases, valvular problems, cardiomyopathies, arrhythmias, family/genetic history of cardiovascular disease
baseline and 5 years
Rate of patients with Atrial Fibrillation secondary to triggers and/or autonomic system imbalance and/or modifiable factors
Time Frame: baseline and 5 years
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
Describe imaging parameters (echocardiogram and cardiac magnetic resonance)
Time Frame: baseline and 5 years
Left ventricle, right ventricle, right and left atrium and valves: morphologies, volumes, dimensions and function
baseline and 5 years
Concentration of laboratory biomarkers
Time Frame: baseline and 5 years
Complete Blood cell count with differential; Interleukin-1, Interleukin-6, High sensitivity C Reactive protein
baseline and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Policlinico Casilino ASL RMB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 15, 2020

Primary Completion (Anticipated)

April 15, 2022

Study Completion (Anticipated)

April 15, 2025

Study Registration Dates

First Submitted

March 19, 2020

First Submitted That Met QC Criteria

March 22, 2020

First Posted (Actual)

March 24, 2020

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 22, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PoliclinicoCasilino1-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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