7-day Holter Monitoring in Adult Patients With Recent IS or TIA, to Measure the Prevalence of Paroxysmal Atrial Fibrillation Including Episodes Less Than 30 Seconds: Transversal Study

NCT04963647 | Unknown

• 1 other identifier: 605-2020-OSS-AUSLBO
• Study Type: observational
• Target: 660
• Locations: 1 country
• Sites: 1

Brief Summary

The main outcome of this study will be to compare the prevalence of PA AF episodes longer than 30 seconds versus the prevalence of PA AF episodes including episodes shorter than 30 seconds, in adult patients who survived IS or TIA with no previous history of AF, after 7-day Holter monitoring. Based on the previous assumptions, the secondary objectives of the project will be:

1. 1.To compare the prevalence of patients diagnosed with BAF after 24-hour, 72-hour, and 7-day Holter monitoring.
2. 2.To study the feasibility of using information obtained from the ECG during sinus rhythm, for example the characteristics of the P-wave, to predict the presence of PA AF and BAF.
3. 3.To Collect a new database of multi-monitored, high-resolution, long-term ECG signals. The data will be used by the My-Atria consortium for research purposes, for the development and validation of arrhythmia detection algorithms.

Conditions

Atrial Fibrillation

Keywords

7 day holter monitoring; tia; Atrial Fibrillation; IS; stroke; Brief atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Absolute number of AF episodes

  Absolute number of AF episodes (i.e. all AF episodes shorter than seven days) and BAF in adult patients with recent IS or TIA with no previous history of AF, in order to identify and compare prevalence rates to determine the clinical relevance of a possible screening process for BAF. Atrial flutter episodes will be considered as AF episodes for the purpose of finding the results, as they both have similar risk factors and therapy.

  7 days

Secondary Outcomes (1)

• Absolute number of BAF

  7 days

Interventions

Adult subjects diagnosed with IS or TIA DIAGNOSTIC_TEST

From the moment the person decides to participate, the patient will undergo the first 24-hour cycle of monitoring with a high-resolution 12-lead Holter. The following day, the Holter report generated will be analyzed by an expert electrocardiographic. After the removal of the first Holter, the study subject will undergo a second monitoring with a 3-lead Holter device for a duration of 6 days, followed by decontamination of the device and archiving of data The electronic data relating to the monitoring periods with Holter will be analyzed with various high-sensitivity AF detection algorithms in order to identify the outcome of the study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population concerns adult subjects admitted to the Neurology and Stroke Network UOC, diagnosed with IS or TIA (confirmed through standardized clinical practice). The enrollments will be made for a total number of about 660 patients. Considering that, in the UOC of Neurology and Metropolitan Stroke Network at the Ospedale Maggiore in Bologna there is an absolute number of patients with stroke or TIA episodes that is equivalent to about 800 per year, the study considers an enrollment phase lasting about a year.

You may qualify if:

• I. Patients admitted to the UOC of Neurology and Metropolitan Stroke Network diagnosed with IS or TIA. The diagnosis will be confirmed through standardized clinical practice which may include one or more of the following diagnostic tests:
• imaging tests such as computed tomography (CT),
• magnetic resonance imaging (MRI),
• computed tomographic angiography (ANGIOTC),
• magnetic resonance angiography (MRA),
• blood flow tests such as cerebral angiography or cerebral arteriography. II. Patients with IS or TIA within 7 days of the clinical episode. III. Obtaining informed consent (signed and dated). IV. Adult patients (over 18 years of age).

You may not qualify if:

• I. Patients with PM o ICD. II. Patients diagnosed with hemorrhagic stroke. III. Patients who have undergone cardiac surgery in the 30 days prior to enrollment.
• IV. More than 7 days between the IS or TIA episode and patient enrollment. V. Patient diagnosed with AF based on a resting ECG performed at the time of enrollment.
• VI. Patient with a previous diagnosis of permanent AF or persistent AF. VII. Patient previously enrolled in this clinical study. VIII. Pregnancy.

Sponsors & Collaborators

• Azienda Usl di Bologna: lead
• Mortara Instrument Europe S.r.l.: collaborator

Study Sites (1)

IRCCS Istituto delle Scienze Neurologiche di Bologna

Bologna, Italy

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Ischemic Attack, Transient; Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Central Study Contacts

Zini Andrea, Md

CONTACT

051 6478481; a.zini@ausl.bologna.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 15, 2021
• Study Start: June 16, 2021
• Primary Completion: July 16, 2022
• Study Completion: June 16, 2023
• Last Updated: July 15, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)