Detection of Silent Atrial Fibrillation aFter Ischemic StrOke

NCT02684825 | Completed DMC

• 1 other identifier: APUmbertoI
• Study Type: interventional
• Target: 317
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate whether, in patients with first-ever atherothrombotic or lacunar stroke without any previous history of atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT), the detection of AF/AFL/AT (silent or symptomatic) by using a continuous cardiac rhythm monitoring with implantable loop recorder (ILR) during the first 12 months of observation is higher than the detection by using a standard cardiac monitoring (physical exam, 12-lead electrocardiogram \[ECG\] at baseline, 3, 6, and 12 months and Holter ECG at 3 months) in the same period of time.

Conditions

Ischemic Stroke; Cerebral Infarction; Brain Ischemia; Brain Infarction; Cerebrovascular Disorders; Brain Disease; Central Nervous System Diseases; Nervous System Diseases; Cardiac Arrhythmias

Keywords

Stroke; ischemic stroke; atrial fibrillation; continuous cardiac monitoring; insertable cardiac monitoring; implantable loop recorder; antithrombotics; anticoagulants; stroke subtype; atherothrombotic stroke; lacunar stroke

Outcome Measures

Primary Outcomes (1)

• Detection rate of AF/AFL/AT within 12 months

  Episodes of AF/AFL/AT will be adjudicated by an independent committee of cardiologists blinded to randomization arm

  12 months

Secondary Outcomes (2)

• Incidence of ischemic stroke recurrence and incidence of the different ischemic stroke subtypes

  36 months

• Reduction of the risk of ischemic stroke and death from all causes

  36 months

Other Outcomes (8)

• Rate of asymptomatic/symptomatic episodes of AF/AFL/AT

  36 months

• Use of oral anticoagulant (OAC) drugs

  36 months

• Use of antiarrhythmic drugs

  36 months

Study Arms (2)

Continuous plus standard cardiac monitoring

EXPERIMENTAL

Continuous cardiac monitoring by Reveal LINQTM- LNQ11 Internal Loop Recorder (ILR) plus standard cardiac monitoring

Device: Reveal LINQTM- LNQ11 Internal Loop Recorder plus standard cardiac monitoring

Standard cardiac monitoring

NO INTERVENTION

Routine cardiac monitoring with follow-up at the same frequency, but with no Implantable Loop Recorder

Interventions

Reveal LINQTM- LNQ11 Internal Loop Recorder plus standard cardiac monitoring DEVICE

Reveal LINQTM- LNQ11 continuously monitors cardiac electric activity for up to three years.

Also known as: Reveal LINQTM- LNQ11

Continuous plus standard cardiac monitoring

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥65 years old in the presence of at least one of the following vascular risk factors: hypertension; diabetes; vascular disease (previous myocardial infarction, peripheral arteriopathy).
• Age between 60 and 64 years old in the presence of at least two of the following vascular risk factors: hypertension; diabetes; vascular disease (previous myocardial infarction, peripheral arteriopathy); smoking.
• Recent (30-60 days after symptom onset) diagnosis of first-ever ischemic stroke. Ischemic stroke is defined as an event characterized by the sudden onset of acute focal neurological symptoms, MR or CT findings consistent with ischemic stroke, and no evidence of other neurological disorders clinically or radiographically to explain. Patients with reversible neurological deficit within 24 hours (clinical TIA), but with a cerebral injury of ischemic origin visible on neuroimages and corresponding to patient symptoms, have to be classified as having an ischemic stroke and considered for the study.
• Diagnosis of atherothrombotic and lacunar etiology, defined according to the TOAST classification criteria and standard diagnostic protocols that have to be fulfilled before randomization (medical history; risk factors; symptoms; cerebral MR and/or CT; 12-lead ECG and/or Holter ECG and/or other standard heart rhythm monitoring procedure; transthoracic and/or transoesophageal echocardiogram; intra- and extracranial vessel ultrasonography and/or CT-Angiography and/or MR-Angiography, also in order to rule out non-atherosclerotic vasculopathies; thrombophilic/hematologic screening if hypercoagulability states or other hematologic disorders are suspected).
• Neurological severity in terms of functional dependency defined as mRS (modified Rankin Scale) score ≤3.
• Written informed consent.

You may not qualify if:

• TIA without evidence of cerebral infarction on neuroimaging corresponding to patient symptoms.
• Diagnosis of cardioembolic stroke based on medical history and cerebral/cardiological/vascular diagnostic evaluation (e.g., evidence of a high-risk emboligenic source from the heart or aortic arch such as: left ventricle or atrium thrombus or "smoke", emboligenic valvular lesions, or emboligenic tumor, patent foramen ovale \[PFO\] associated with a possible venous thromboembolic source and hence eligible for oral anticoagulant \[OAC\] therapy, aortic arch plaques having \>3 mm thickness or containing mobile components, or any other high-risk embolic lesion).
• Diagnosis of ischemic stroke of different etiopathogenesis, for example due to non-atherosclerotic vasculopathies, hypercoagulability states (diagnosed by a thrombophilic screening) or other hematologic disorders; or diagnosis of cryptogenic stroke.
• Previous documented history of atrial fibrillation (AF) or atrial flutter (AFL)
• History of untreated hyperthyroidism
• History of myocardial infarction \<1 month before the study screening visit
• Valvular disease requiring immediate surgical intervention
• Recent (\<6 months before the study screening visit) cardiac surgery
• Other conditions associated with an increased risk of AF: sick sinus syndrome, recent (\<14 days before the study Screening visit) surgery; current infections
• Permanent indication for anticoagulation
• Contraindications to OAC therapy
• Stroke associated with severe functional disability defined as mRS\>3
• Hear failure associated with severe ventricular dysfunction and ejection fraction ≤40%
• Indication for pacemaker or defibrillator implant
• Any condition that, in the opinion of the investigator, could make non feasible or hazardous patient's participation in the study or any condition that could compromise the completion of patient's participation in terms of follow-up visits (for example, diseases associated with a poor prognosis and life expectancy \<1 year).

Sponsors & Collaborators

• Danilo Toni: lead
• Associazione Italiana Aritmologia e Cardiostimolazione (A.I.A.C.) - Stefano Strano, MD: collaborator
• Boehringer Ingelheim: collaborator
• Medtronic Italia S.p.A.: collaborator
• Bayer S.p.A: collaborator

Study Sites (1)

Azienda Policlinico Umberto I

Rome, 00161, Italy

Location

MeSH Terms

Conditions

Ischemic Stroke; Cerebral Infarction; Brain Ischemia; Brain Infarction; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Stroke; Atrial Fibrillation; Stroke, Lacunar

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Heart Diseases; Cerebral Small Vessel Diseases; Thrombotic Stroke

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Emergency Department Stroke Unit - Associate Professor of Neurology

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: February 18, 2016
• Study Start: October 1, 2015
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: June 29, 2023

Record last verified: 2023-06

Locations

IT (1)