Ischemic StrokeAF-SPICENCT05134454
Atrial Fibrillation Screening Post Ischemic Cerebrovascular Events
A study testing Extended ECG investigation in people with Ischemic Stroke and TIA, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Stroke is one of the leading causes behind death and permanent disability in adults. Atrial fibrillation (AF) is the most common clinical arrhythmia and its prevalence is steeply increasing with age. Atrial fibrillation is associated with a manifold increase in the risk for stroke. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Ischemic Stroke, TIA
- What is being tested?
- Extended ECG investigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,300 participants
- Where
- 1 siteSweden
- Study dates
- 20 Jan 2022to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients aged ≥ 70 years
- A diagnosis of ischemic stroke or TIA within 14 days from inclusion.
Who cannot join
- Previously diagnosed atrial fibrillation
- Contraindication to oral anticoagulant treatment according to Summary of Product Characteristics.
- Indication for anticoagulant treatment other than atrial fibrillation, e.g. venous thromboembolism or mechanical heart valve prosthesis
- Dual antiplatelet therapy not interchangeable to oral anticoagulation
- Patients with pacemaker, implantable cardioverter defibrillator or implantable cardiac monitor.
- Patients who, according to the investigator, will not be able to comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet Danderyds University Hospital
Stockholm, Stockholm County, 18288
About this study
Official title: A Multicenter, National, Investigator-initiated, Randomized, Parallel-group, Registerbased Superiority Study to Compare Extended ECG Monitoring Versus Standard ECG Monitoring of 1-2 Days in Elderly Patients With Ischemic Stroke or TIA.
Stroke is one of the leading causes behind death and permanent disability in adults. Atrial fibrillation (AF) is the most common clinical arrhythmia and its prevalence is steeply increasing with age. Atrial fibrillation is associated with a manifold increase in the risk for stroke.
It is considered important to investigate the heart rhythm in stroke survivors without previously known AF, because detection of AF will prompt a change in antithrombotic treatment with subsequent lowering of the risk of recurrent stroke.
Read more
There are so far very few studies on the prognostic impact of ECG investigations post stroke. Despite this knowledge gap, ECG investigation post stroke is given high priority in national and international guidelines.
Considerable clinical resources are currently invested in these ECG investigations without knowledge of its utility.
The investigators plan a nationwide, randomised, register-based study (RRCT) including patients aged at least 70 years receiving in-hospital care for stroke or TIA (Transient Ischemic Attack). Included patients will be randomised to standard investigation (1-2 days of ECG ) or extended ECG investigation (14 days of ECG performed at least twice). Patients diagnosed AF will be offered anticoagulation treatment. Long-term follow-up will be performed via swedish health care registers.
The result of this trial will have major impact on the ECG screening recommendations for patients who have had stroke, a large group of patients with dismal prognosis.
Read the detailed description
Purpose and aims
The purpose of the trial is to study the prognostic impact of ECG investigation after stroke or TIA.
The aim is to investigate if extended ECG screening after stroke as compared to standard ECG screening reduces the occurrence of the primary composite endpoint of stroke, death and intracranial bleeding in patients with stroke or transient ischemic attack (TIA). Secondary aims include effects on major bleeding, myocardial infarction, pacemaker implantation, atrial fibrillation prevalence, oral anticoagulation (OAC) treatment and cost effectiveness.
Survey of the field Ischemic stroke is one of the leading causes of mortality worldwide, and a major cause behind permanent disability in adults. Atrial fibrillation (AF) is the most prevalent permanent clinically relevant arrhythmia with a steeply increasing incidence with advancing age. Atrial fibrillation is also one of the strongest risk factors for stroke. The increased stroke risk associated with AF can be markedly reduced by OAC treatment.
Unfortunately, AF is paroxysmal and asymptomatic in a significant proportion of patients, leading to lower detection rates and a similar proportion of stroke survivors with an untreated risk factor and higher risk of stroke recurrence. For this reason, it is widely recommended to make ECG recordings in patients suffering from stroke and TIA in order to detect previously undiagnosed AF.
Despite this, no study so far has been reported to bring evidence on the benefit of ECG AF screening in terms of reduced stroke recurrence and mortality after a stroke event. However, several studies have reported the yield of new AF diagnosis in stroke/TIA patients using different ECG recording strategies in different populations.
The knowledge gap on the possible benefits and cost effectiveness of ECG investigation after stroke/TIA has led to a large variation in international recommendations, a situation bringing uncertainty among policy makers, the profession and patients. The variation in recommendations from different societies have unusual proportions. There is also a large variation in clinical practice between different stroke units in Sweden.
Furthermore, since the magnitude of the net benefit (or net harm) of the ECG investigation is not yet known, extensive clinical resources as well as patient effort are today put into these ECG investigations without knowing about the benefit for the patient or cost effectiveness.
Research Idea
The study will compare current standard ECG investigation after stroke/TIA with an extended ECG investigation strategy and compare long-term prognosis in terms of hard clinical endpoints among participants.
P: Patients aged at least 70 years treated in Swedish stroke units for ischemic stroke/TIA who after 24-48 hours of standard ECG investigation have shown no signs of atrial fibrillation
I: Extended ECG ambulatory recording, at least 2 separate recordings of 14 days each 2-4 months apart
C: standard Swedish ECG investigation, continuous ECG for 24-48 hours
O: Composite endpoint of recurrent stroke, all-cause mortality and intracerebral bleeding
For the year 2020, the mean age of Swedish stroke patients was 75 years, with a higher mean age among women. Incidence of AF is strongly related to age as confirmed in epidemiological studies and in screening studies. The selected cut-off age of 70 years for this study will include three fourths of stroke patients targeting those at highest risk for AF. However, higher age implies a risk for lower compliance to ECG recordings. This has been taken into account when choosing ECG device. Hence, the chosen cut-off age for inclusion is deemed to balance the yield of the ECG investigation, the benefit from OAC treatment and stroke risk if AF is detected and the expected level of compliance to procedures and treatment related to the study.
The ECG investigation in the control arm is based on the minimum recommendations for stroke care issued by the Swedish board of health and welfare. There are however several guidelines from international societies recommending higher ambitions for this investigation, i.e longer ECG recordings. Several Swedish stroke units are implementing ECG investigations after stroke/TIA with ambitions higher than those stated by national minimum recommendations, assuming that these investigations will give more benefit to the patient. The study design is calculated to give a marked difference between the control and intervention groups to overcome the possible problem with an underpowered result reported from a previous study in the field.
Plans and methods for pilot study The pilot study will engage five to six patient-including stroke units which are already recruited. The pilot study is planned to include 200-300 patients with the aim to evaluate feasibility of study management, patient inclusion, inclusion rate, ECG recordings, flow of ECG data and short-term follow-up of positive ECG findings.
Parallel to the pilot study, a comprehensive, digital survey on ECG investigation practice covering all Swedish stroke units will be undertaken. This survey will be sent to the stroke units commencing in september 2021. The outcome of the survey will give a complete and up-to-date view of clinical practice and a possibility to identify suitable sites for the main trial.
During 2020, there were 28 000 patients included in national stroke register for stroke or TIA and three fourths of these patients were aged 70 years or older. The pilot and main study are planned to include 3300 patients during 2021-2024.
- Conditions
- Ischemic Stroke, TIA
- Being tested
- Extended ECG investigation
- Keywords
- stroke, TIA, atrial fibrillation, ECG, oral anticoagulation
- Medical subject headings
- Ischemic Stroke, Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended ECG investigationDiagnostic test
At least two long-term ambulatory ECG recordings with a duration of 14 days each using Philips ePatch (https://www.myheartmonitor.com/device/epatch/). The two recordings should be 2-4 months apart.
| Study group | Role | What they receive |
|---|---|---|
| Extended ECG investigation | Experimental | Participants will undergo 0-48 hours of continuous ECG recording and at least two long-term continuous ambulatory ECG recordings with a duration of 14 days each. Receives: Diagnostic Test: Extended ECG investigation |
| Standard of care | No intervention | Participants will undergo 24-48 hours of continuous ECG recording. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of stroke, death and intracerebral bleeding
Stroke is defined as the occurence of International Classification of Diseases (ICD) 10 codes I63 in swedish health care registers. Intracranial bleeding is defined as the occurence of ICD 10 codes I61 in swedish health care registers. Mortality is defined as death reported by the swedish registers on cause of death.
Measured: at least 36 months of follow-up (study event driven)
Secondary outcomes (8)
Individual components of the primary endpoint
Stroke is defined as the occurence of ICD 10 codes I63 in swedish health care registers. Intracranial bleeding is defined as the occurence of ICD 10 codes I61 in swedish health care registers. Mortality is defined as death reported by the swedish registers on cause of death.
Measured: at least 36 months of follow-up (study event driven)
Major bleeding
Defined as the occurence of any of the following ICD 10 codes in swedish health care registers: I60, I62, I850, I983, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K284, K286, K290, K625, K661, K920-921, K922, N02, R04, R58, T810, D629, D50-64,D65-69
Measured: at least 36 months of follow-up (study event driven)
Myocardial infarction
Defined as the occurence of any of the following ICD 10 codes in swedish health care registers: I21
Measured: at least 36 months of follow-up (study event driven)
Pacemaker implantation
Defined as the occurence of any of the following measures in swedish health care registers: FPE00-96
Measured: at least 36 months of follow-up (study event driven)
Anticoagulation treatment
Defined as the occurence of any of the following ICD 10 codes in swedish health care registers: Z921 or the prescription of any of the following Anatomical Therapeutic Chemical Classification System (ATC) codes: B01AA, B01AE, B01AF
Measured: at least 36 months of follow-up (study event driven)
Atrial fibrillation prevalence
The proportion of participants with the ICD 10 code I48 in swedish health care registers divided by the total number of participants.
Measured: at least 36 months of follow-up (study event driven)
Adherence to long-term ECG recording
For each participant, the duration of the actual ECG signal acquired during long-term ECG recording will be divided by the theoretical maximum duration of ECG signal which is 14 days. The resulting proportion is the adherence.
Example: A participant discontinues the ECG recording after 7 days and the investigators will receive 7 days of ECG of the expected 14 days of ECG signal for interpretation. In this case, adherence will be 7/14 = 50%.
Measured: at least 36 months of follow-up (study event driven)
Incidence of other prognostic arrhythmia during long-term ECG recording.
The incidence of atrioventricular block degree 2 or 3, ventricular tachycardia, >5% premature ventricular ectopic beats, pauses > 3 seconds and bradycardia slower than 40/min and during long-term ECG recording.
Measured: at least 36 months of follow-up (study event driven)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start20 Jan 2022
- Primary completion31 Dec 2025
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Model description
- multicenter, national, investigator-initiated, randomized, parallel-group, register based superiority study
- Masking
- None (open label)
- Enrolment
- 3,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University, Örebro University, Sweden, Lund University, Umeå University, The Swedish Research Council, Swedish Heart Lung Foundation
- Responsible party
- Principal investigator, Johan Engdahl, Karolinska Institutet
- Investigators
- Johan Engdahl, MD, PhD, Study chair, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134454
- Acronym
- AF-SPICE
- Status last verified
- Aug 2026
- First submitted
- 20 Sep 2021
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant datat will be shared upon reasonable request.
Publications
Engdahl J, Straat K, Isaksson E, Rooth E, Svennberg E, Norrving B, Euler MV, Hellqvist K, Gu W, Strom JO, Sjalander S, Eriksson M, Asberg S, Wester P. Multicentre, national, investigator-initiated, randomised, parallel-group, register-based superiority trial to compare extended ECG monitoring versus standard ECG monitoring in elderly patients with ischaemic stroke or transient ischaemic attack and the effect on stroke, death and intracerebral bleeding: the AF SPICE protocol. BMJ Open. 2023 Nov 23;13(11):e073470. doi: 10.1136/bmjopen-2023-073470.
PubMed 37996238
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, National, Investigator-initiated, Randomized, Parallel-group, Registerbased Superiority Study to Compare Extended ECG Monitoring Versus Standard ECG Monitoring of 1-2 Days in Elderly Patients With Ischemic Stroke or TIA.
- ClinicalTrials.gov ID
- NCT05134454
- Acronym / sponsor ID
- AF-SPICE
- Conditions
- Ischemic Stroke, TIA
- Keywords
- stroke, TIA, atrial fibrillation, ECG, oral anticoagulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,300 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Uppsala University, Örebro University, Sweden, Lund University, Umeå University, The Swedish Research Council, Swedish Heart Lung Foundation
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- Dec 2028 (estimated)
- First posted
- 26 Nov 2021 (actual)
- 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.
Stroke is one of the leading causes behind death and permanent disability in adults. Atrial fibrillation (AF) is the most common clinical arrhythmia and its prevalence is steeply increasing with age. Atrial fibrillation is associated with a manifold increase in the risk for stroke.
It is considered important to investigate the heart rhythm in stroke survivors without previously known AF, because detection of AF will prompt a change in antithrombotic treatment with subsequent lowering of the risk of recurrent stroke.
There are so far very few studies on the prognostic impact of ECG investigations post stroke. Despite this knowledge gap, ECG investigation post stroke is given high priority in national and international guidelines.
Considerable clinical resources are currently invested in these ECG investigations without knowledge of its utility.
The investigators plan a nationwide, randomised, register-based study (RRCT) including patients aged at least 70 years receiving in-hospital care for stroke or TIA (Transient Ischemic Attack). Included patients will be randomised to standard investigation (1-2 days of ECG ) or extended ECG investigation (14 days of ECG performed at least twice). Patients diagnosed AF will be offered anticoagulation treatment. Long-term follow-up will be performed via swedish health care registers.
The result of this trial will have major impact on the ECG screening recommendations for patients who have had stroke, a large group of patients with dismal prognosis.
Detailed description
Purpose and aims
The purpose of the trial is to study the prognostic impact of ECG investigation after stroke or TIA.
The aim is to investigate if extended ECG screening after stroke as compared to standard ECG screening reduces the occurrence of the primary composite endpoint of stroke, death and intracranial bleeding in patients with stroke or transient ischemic attack (TIA). Secondary aims include effects on major bleeding, myocardial infarction, pacemaker implantation, atrial fibrillation prevalence, oral anticoagulation (OAC) treatment and cost effectiveness.
Survey of the field Ischemic stroke is one of the leading causes of mortality worldwide, and a major cause behind permanent disability in adults. Atrial fibrillation (AF) is the most prevalent permanent clinically relevant arrhythmia with a steeply increasing incidence with advancing age. Atrial fibrillation is also one of the strongest risk factors for stroke. The increased stroke risk associated with AF can be markedly reduced by OAC treatment.
Unfortunately, AF is paroxysmal and asymptomatic in a significant proportion of patients, leading to lower detection rates and a similar proportion of stroke survivors with an untreated risk factor and higher risk of stroke recurrence. For this reason, it is widely recommended to make ECG recordings in patients suffering from stroke and TIA in order to detect previously undiagnosed AF.
Despite this, no study so far has been reported to bring evidence on the benefit of ECG AF screening in terms of reduced stroke recurrence and mortality after a stroke event. However, several studies have reported the yield of new AF diagnosis in stroke/TIA patients using different ECG recording strategies in different populations.
The knowledge gap on the possible benefits and cost effectiveness of ECG investigation after stroke/TIA has led to a large variation in international recommendations, a situation bringing uncertainty among policy makers, the profession and patients. The variation in recommendations from different societies have unusual proportions. There is also a large variation in clinical practice between different stroke units in Sweden.
Furthermore, since the magnitude of the net benefit (or net harm) of the ECG investigation is not yet known, extensive clinical resources as well as patient effort are today put into these ECG investigations without knowing about the benefit for the patient or cost effectiveness.
Research Idea
The study will compare current standard ECG investigation after stroke/TIA with an extended ECG investigation strategy and compare long-term prognosis in terms of hard clinical endpoints among participants.
P: Patients aged at least 70 years treated in Swedish stroke units for ischemic stroke/TIA who after 24-48 hours of standard ECG investigation have shown no signs of atrial fibrillation
I: Extended ECG ambulatory recording, at least 2 separate recordings of 14 days each 2-4 months apart
C: standard Swedish ECG investigation, continuous ECG for 24-48 hours
O: Composite endpoint of recurrent stroke, all-cause mortality and intracerebral bleeding
For the year 2020, the mean age of Swedish stroke patients was 75 years, with a higher mean age among women. Incidence of AF is strongly related to age as confirmed in epidemiological studies and in screening studies. The selected cut-off age of 70 years for this study will include three fourths of stroke patients targeting those at highest risk for AF. However, higher age implies a risk for lower compliance to ECG recordings. This has been taken into account when choosing ECG device. Hence, the chosen cut-off age for inclusion is deemed to balance the yield of the ECG investigation, the benefit from OAC treatment and stroke risk if AF is detected and the expected level of compliance to procedures and treatment related to the study.
The ECG investigation in the control arm is based on the minimum recommendations for stroke care issued by the Swedish board of health and welfare. There are however several guidelines from international societies recommending higher ambitions for this investigation, i.e longer ECG recordings. Several Swedish stroke units are implementing ECG investigations after stroke/TIA with ambitions higher than those stated by national minimum recommendations, assuming that these investigations will give more benefit to the patient. The study design is calculated to give a marked difference between the control and intervention groups to overcome the possible problem with an underpowered result reported from a previous study in the field.
Plans and methods for pilot study The pilot study will engage five to six patient-including stroke units which are already recruited. The pilot study is planned to include 200-300 patients with the aim to evaluate feasibility of study management, patient inclusion, inclusion rate, ECG recordings, flow of ECG data and short-term follow-up of positive ECG findings.
Parallel to the pilot study, a comprehensive, digital survey on ECG investigation practice covering all Swedish stroke units will be undertaken. This survey will be sent to the stroke units commencing in september 2021. The outcome of the survey will give a complete and up-to-date view of clinical practice and a possibility to identify suitable sites for the main trial.
During 2020, there were 28 000 patients included in national stroke register for stroke or TIA and three fourths of these patients were aged 70 years or older. The pilot and main study are planned to include 3300 patients during 2021-2024.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- multicenter, national, investigator-initiated, randomized, parallel-group, register based superiority study
| Arm | Type | Receives |
|---|---|---|
| Extended ECG investigation | Experimental | Diagnostic Test: Extended ECG investigationParticipants will undergo 0-48 hours of continuous ECG recording and at least two long-term continuous ambulatory ECG recordings with a duration of 14 days each. |
| Standard of care | No intervention | –Participants will undergo 24-48 hours of continuous ECG recording. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients aged ≥ 70 years
- A diagnosis of ischemic stroke or TIA within 14 days from inclusion.
Key exclusion criteria (6 listed)
- Previously diagnosed atrial fibrillation
- Contraindication to oral anticoagulant treatment according to Summary of Product Characteristics.
- Indication for anticoagulant treatment other than atrial fibrillation, e.g. venous thromboembolism or mechanical heart valve prosthesis
- Dual antiplatelet therapy not interchangeable to oral anticoagulation
- Patients with pacemaker, implantable cardioverter defibrillator or implantable cardiac monitor.
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 |
|---|---|---|
| Extended ECG investigationAt least two long-term ambulatory ECG recordings with a duration of 14 days each using Philips ePatch (https://www.myheartmonitor.com/device/epatch/). The two recordings should be 2-4 months apart. | Diagnostic test | Extended ECG investigation |
Primary outcome
Composite of stroke, death and intracerebral bleeding
Time frame: at least 36 months of follow-up (study event driven)
Stroke is defined as the occurence of International Classification of Diseases (ICD) 10 codes I63 in swedish health care registers. Intracranial bleeding is defined as the occurence of ICD 10 codes I61 in swedish health care registers. Mortality is defined as death reported by the swedish registers on cause of death.
8 secondary outcomes
Individual components of the primary endpoint
Time frame: at least 36 months of follow-up (study event driven)
Major bleeding
Time frame: at least 36 months of follow-up (study event driven)
Myocardial infarction
Time frame: at least 36 months of follow-up (study event driven)
Pacemaker implantation
Time frame: at least 36 months of follow-up (study event driven)
Anticoagulation treatment
Time frame: at least 36 months of follow-up (study event driven)
Atrial fibrillation prevalence
Time frame: at least 36 months of follow-up (study event driven)
Adherence to long-term ECG recording
Time frame: at least 36 months of follow-up (study event driven)
Incidence of other prognostic arrhythmia during long-term ECG recording.
Time frame: at least 36 months of follow-up (study event driven)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Derived from this study: PubMed 37996238Engdahl J, Straat K, Isaksson E, Rooth E, Svennberg E, Norrving B, Euler MV, Hellqvist K, Gu W, Strom JO, Sjalander S, Eriksson M, Asberg S, Wester P. Multicentre, national, investigator-initiated, randomised, parallel-group, register-based superiority trial to compare extended ECG monitoring versus standard ECG monitoring in elderly patients with ischaemic stroke or transient ischaemic attack and the effect on stroke, death and intracerebral bleeding: the AF SPICE protocol. BMJ Open. 2023 Nov 23;13(11):e073470. doi: 10.1136/bmjopen-2023-073470.
- Individual participant dataSharing planned: Yes. Individual participant datat will be shared upon reasonable request.
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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.
Johan Engdahl, MD, PhD study chair
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extended ECG investigation in people with Ischemic Stroke and TIA, run by Karolinska Institutet at 1 site in Sweden.
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 2 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
Composite of stroke, death and intracerebral bleeding (time frame: at least 36 months of follow-up (study event driven)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05134454, which also lists 1 linked publication.
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 5 Aug 2026.