Ischemic StrokeSAFFONCT02684825
Detection of Silent Atrial Fibrillation aFter Ischemic StrOke
A study testing Reveal LINQTM- LNQ11 Internal Loop Recorder plus standard cardiac monitoring in people with Ischemic Stroke and Cerebral Infarction, run by Danilo Toni at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Ischemic Stroke, Cerebral Infarction, Brain Ischemia
- What is being tested?
- Reveal LINQTM- LNQ11 Internal Loop Recorder plus standard cardiac monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 317 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2015to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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).
- Severe renal failure or liver disease
- Participation in any other clinical trial that can interfere with the objectives of the study
- Poor patient's compliance that could compromise his/her correct participation in the study
- Patient's refusal to give his/her informed consent for the participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Silent Atrial Fibrillation aFter Ischemic StrOke (SAFFO) Guided by Implantable Loop Recorder. Multicentre Italian Trial Based on Stroke Unit Network With Paired Cardio-Arrhythmology Units (Italian Neurocardiology Unit Network)
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.
Read the detailed description
Atrial fibrillation (AF) is associated with a high risk of stroke and its prevalence increases in subjects aged ≥65 years. After an ischemic stroke, the use of standard monitoring methods may underestimate the detection rate of AF. Recent studies demonstrated a fourfold to sixfold increase in the detection of AF with prolonged ECG monitoring as compared to standard cardiac monitoring in patients with cryptogenic stroke. Hence, it is very likely that even patients having a first atherothrombotic or lacunar stroke with high burden of vascular risk factors are exposed to increased risk of developing AF in the subsequent years and AF may be the cause underlying possible recurrent strokes.
SAFFO trial has the objective to evaluate the detection of AF or atrial flutter (AFL) as first diagnosis by implantable loop recorder (ILR) in patients with first-ever atherothrombotic or lacunar stroke. Patients with recent (30-60 days after symptom onset) diagnosis of first-ever atherothrombotic or lacunar ischemic stroke who fulfill inclusion criteria will be randomized to either continuous cardiac monitoring using an ILR plus standard cardiac monitoring (intervention arm) or standard cardiac monitoring alone (control arm) with a ratio of 1:1. The hypothesis is that the detection of of AF/AFL by using ILR will be higher than that observed by using standard cardiac monitoring. Secondary and tertiary objectives of the study include exploratory analyses on the incidence of recurrent strokes and different stroke subtypes and on the reduction of stroke risk and death from all causes in all study patients, in the two randomization groups and, in particular, in patients treated with antiplatelet therapy versus those treated with oral anticoagulant (OAC) therapy, the latter being implemented and guided by the detection of clinically meaningful episodes of AF/AFL/AT using ILR compared with standard cardiac monitoring. Moreover, this study has the objective to evaluate a clinical, neuroimaging, and echocardiographic profile predictive of AF/AFL/AT first diagnosis and stroke recurrence.
SAFFO is a prospective, multicenter, randomized, controlled, open-label trial with blinded assessment of outcome measures. Diagnosis of atherothrombotic and lacunar etiology will be defined according to TOAST (trial of ORG 10172 in acute stroke treatment) / CCS (Causative Classification System for ischemic stroke) classification criteria and standard diagnostic protocols that have to be fulfilled before randomization (medical history; risk factors; symptoms; cerebral magnetic resonance [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).
ILR (Medtronic Reveal LINQTM- LNQ11REVEAL LinQ) implantation will be performed within 8 days after randomization and will allow a continuous monitoring by single-lead ECG registration for 3 years. Standard cardiac rhythm monitoring includes: detailed data collection on any possible patient's symptom suggestive of AF/AFL/AT, physical exam including cardiovascular examination, 12-lead ECG, and 24-hour Holter ECG performed at 3-month follow-up visit.
If positive, SAFFO trial could have important clinical implications in terms of changing the standard diagnostic protocol in patients with atherothrombotic and lacunar stroke, and of increasing the shift of secondary prevention treatment from antiplatelet to anticoagulant therapy when indicated.
- Conditions
- Ischemic Stroke, Cerebral Infarction, Brain Ischemia, Brain Infarction, Cerebrovascular Disorders, Brain Disease
- Being tested
- Reveal LINQTM- LNQ11 Internal Loop Recorder plus standard cardiac monitoring
- Keywords
- Stroke, ischemic stroke, atrial fibrillation, continuous cardiac monitoring, insertable cardiac monitoring, implantable loop recorder, antithrombotics, anticoagulants, stroke subtype, atherothrombotic stroke, lacunar stroke
- Medical subject headings
- Ischemic Stroke, Cerebral Infarction, Brain Ischemia, Brain Infarction, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reveal LINQTM- LNQ11 Internal Loop Recorder plus standard cardiac monitoringDevice
Also called Reveal LINQTM- LNQ11
Reveal LINQTM- LNQ11 continuously monitors cardiac electric activity for up to three years.
| Study group | Role | What they receive |
|---|---|---|
| Continuous plus standard cardiac monitoring | Experimental | Continuous cardiac monitoring by Reveal LINQTM- LNQ11 Internal Loop Recorder (ILR) plus standard cardiac monitoring Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (2)
Incidence of ischemic stroke recurrence and incidence of the different ischemic stroke subtypes
Stroke subtypes will be adjudicated by an independent committee of neurologists blinded to randomization arm
Measured: 36 months
Reduction of the risk of ischemic stroke and death from all causes
Reduction of the risk of ischemic stroke and death from all causes will be evaluated in particular in patients treated with antiplatelet therapy versus those treated with OAC therapy, the latter being implemented and guided by the detection of clinically meaningful episodes of AF/AFL/AT using ILR compared with standard cardiac monitoring
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startOct 2015
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danilo Toni
- Sponsor type
- University, hospital or other
- Collaborators
- Associazione Italiana Aritmologia e Cardiostimolazione (A.I.A.C.) - Stefano Strano, MD, Boehringer Ingelheim, Medtronic Italia S.p.A., Bayer S.p.A
- Responsible party
- Sponsor-investigator, Danilo Toni, Azienda Policlinico Umberto I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684825
- Sponsor's protocol ID
- APUmbertoI
- Acronym
- SAFFO
- Status last verified
- Jun 2023
- First submitted
- 2 Feb 2016
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Silent Atrial Fibrillation aFter Ischemic StrOke (SAFFO) Guided by Implantable Loop Recorder. Multicentre Italian Trial Based on Stroke Unit Network With Paired Cardio-Arrhythmology Units (Italian Neurocardiology Unit Network)
- ClinicalTrials.gov ID
- NCT02684825
- Acronym / sponsor ID
- SAFFO / APUmbertoI
- Conditions
- Ischemic Stroke, Cerebral Infarction, Brain Ischemia, Brain Infarction, Cerebrovascular Disorders, Brain Disease
- Keywords
- Stroke, ischemic stroke, atrial fibrillation, continuous cardiac monitoring, insertable cardiac monitoring, implantable loop recorder, antithrombotics, anticoagulants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Danilo ToniUniversity, hospital or other
- Collaborators
- Associazione Italiana Aritmologia e Cardiostimolazione (A.I.A.C.) - Stefano Strano, MD, Boehringer Ingelheim, Medtronic Italia S.p.A., Bayer S.p.A
- Study start
- Oct 2015
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 18 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Atrial fibrillation (AF) is associated with a high risk of stroke and its prevalence increases in subjects aged ≥65 years. After an ischemic stroke, the use of standard monitoring methods may underestimate the detection rate of AF. Recent studies demonstrated a fourfold to sixfold increase in the detection of AF with prolonged ECG monitoring as compared to standard cardiac monitoring in patients with cryptogenic stroke. Hence, it is very likely that even patients having a first atherothrombotic or lacunar stroke with high burden of vascular risk factors are exposed to increased risk of developing AF in the subsequent years and AF may be the cause underlying possible recurrent strokes.
SAFFO trial has the objective to evaluate the detection of AF or atrial flutter (AFL) as first diagnosis by implantable loop recorder (ILR) in patients with first-ever atherothrombotic or lacunar stroke. Patients with recent (30-60 days after symptom onset) diagnosis of first-ever atherothrombotic or lacunar ischemic stroke who fulfill inclusion criteria will be randomized to either continuous cardiac monitoring using an ILR plus standard cardiac monitoring (intervention arm) or standard cardiac monitoring alone (control arm) with a ratio of 1:1. The hypothesis is that the detection of of AF/AFL by using ILR will be higher than that observed by using standard cardiac monitoring. Secondary and tertiary objectives of the study include exploratory analyses on the incidence of recurrent strokes and different stroke subtypes and on the reduction of stroke risk and death from all causes in all study patients, in the two randomization groups and, in particular, in patients treated with antiplatelet therapy versus those treated with oral anticoagulant (OAC) therapy, the latter being implemented and guided by the detection of clinically meaningful episodes of AF/AFL/AT using ILR compared with standard cardiac monitoring. Moreover, this study has the objective to evaluate a clinical, neuroimaging, and echocardiographic profile predictive of AF/AFL/AT first diagnosis and stroke recurrence.
SAFFO is a prospective, multicenter, randomized, controlled, open-label trial with blinded assessment of outcome measures. Diagnosis of atherothrombotic and lacunar etiology will be defined according to TOAST (trial of ORG 10172 in acute stroke treatment) / CCS (Causative Classification System for ischemic stroke) classification criteria and standard diagnostic protocols that have to be fulfilled before randomization (medical history; risk factors; symptoms; cerebral magnetic resonance [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).
ILR (Medtronic Reveal LINQTM- LNQ11REVEAL LinQ) implantation will be performed within 8 days after randomization and will allow a continuous monitoring by single-lead ECG registration for 3 years. Standard cardiac rhythm monitoring includes: detailed data collection on any possible patient's symptom suggestive of AF/AFL/AT, physical exam including cardiovascular examination, 12-lead ECG, and 24-hour Holter ECG performed at 3-month follow-up visit.
If positive, SAFFO trial could have important clinical implications in terms of changing the standard diagnostic protocol in patients with atherothrombotic and lacunar stroke, and of increasing the shift of secondary prevention treatment from antiplatelet to anticoagulant therapy when indicated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous plus standard cardiac monitoring | Experimental | Device: Reveal LINQTM- LNQ11 Internal Loop Recorder plus standard cardiac monitoringContinuous cardiac monitoring by Reveal LINQTM- LNQ11 Internal Loop Recorder (ILR) 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reveal LINQTM- LNQ11 Internal Loop Recorder plus standard cardiac monitoringAlso: Reveal LINQTM- LNQ11Reveal LINQTM- LNQ11 continuously monitors cardiac electric activity for up to three years. | Device | Continuous plus standard cardiac monitoring |
Primary outcome
Detection rate of AF/AFL/AT within 12 months
Time frame: 12 months
Episodes of AF/AFL/AT will be adjudicated by an independent committee of cardiologists blinded to randomization arm
2 secondary outcomes
Incidence of ischemic stroke recurrence and incidence of the different ischemic stroke subtypes
Time frame: 36 months
Reduction of the risk of ischemic stroke and death from all causes
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reveal LINQTM- LNQ11 Internal Loop Recorder plus standard cardiac monitoring in people with Ischemic Stroke and Cerebral Infarction, run by Danilo Toni at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of AF/AFL/AT within 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023; AzTrials last refreshed its copy on 7 Nov 2026.