StrokeSTARGATENCT05717504
Sweet spoT for cArdiac Rhythm monitorinG After sTrokE
A study testing Implantable Loop Recorder and Quality of life survey in people with Stroke and Atrial Fibrillation, run by Luciano A. Sposato.
Trial summary
The goal of this clinical trial is to compare the use of long-term vs. shorter-term heart monitoring to detect atrial fibrillation after stroke. Patients will be implanted with a loop recorder and will have study follow-up at 3-, 6- an 12-months after implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Atrial Fibrillation
- What is being tested?
- Implantable Loop Recorder and Quality of life survey
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Feb 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with cortical or subcortical, cryptogenic or non-cryptogenic acute ischemic stroke
Who cannot join
- AF on 24-h inpatient or Holter monitoring
- Atrial or ventricular thrombus
- Other major-risk cardioembolic sources (e.g., mechanical valve)
- Other indications (e.g., venous thromboembolism) or contraindications for OACs.
About this study
Official title: STARGATE (Sweet spoT for cArdiac Rhythm monitorinG After sTrokE) Pilot Trial: A Pilot-feasibility Randomized Controlled Trial
The goal of this clinical trial is to compare the use of long-term vs. shorter-term heart monitoring to detect atrial fibrillation after stroke.
Patients will be implanted with a loop recorder and will have study follow-up at 3-, 6- an 12-months after implantation.
The investigators will evaluate 24 patients, between the 3 centers, in the same way the investigators plan to evaluate a larger number of participants (>1000) in a future study. This will allow us to learn if such a study is possible, identify potential implementation challenges, and develop strategies to overcome those difficulties.
Read the detailed description
Atrial fibrillation (AF) is the most common heart rhythm disorder. Its name comes from the fibrillation (i.e. quivering) of the two upper chambers (atria) of the heart instead of a coordinated contraction, causing a rapid, irregular heart rate. This irregular contraction is ineffective, leading to the development clots in the heart. These clots can travel through the bloodstream until they get stuck in a brain artery. Millions of brain cells that depend on the oxygen supplied by the blocked artery die within minutes. This is known as a stroke. Strong blood thinners known as anticoagulants can lower stroke risk by 64% in AF patients when the AF is detected on an electrocardiogram (ECG) or if it lasts more than 24h on a heart monitor. Therefore, doctors use cardiac monitors to record the heartbeats of stroke patients for up to 3 years. It was historically thought, but not proven, that if AF was found in stroke patients, using anticoagulants could prevent a second stroke. However, recent information suggests that using cardiac monitors in stroke patients increases AF detection and anticoagulants prescription without a reduction in the number of new strokes. The failure to prevent a second stroke is likely the consequence of cardiac monitors sometimes detecting very short-duration AFs, which may have a low risk of stroke. If AFs last only for a few minutes or hours, anticoagulants may not be needed.
Patients with a stroke and not know atrial fibrillation will be implanted with a loop recorder and randomized in two groups (disclosure arm and non-disclosure arm). Patients will have phone follow-up visits at 3, 6 and 12 months after implantation. A quality-of-life survey will be performed at the last study visit.
This study will assess if it is possible to organize a large clinical trial comparing the use of long-term vs. shorter-term heart monitoring. The investigators will evaluate 24 patients, between the 3 centers, in the same way, the investigators plan to evaluate a larger number of participants (>1000) in a future study. This will allow us to learn if such a study is possible, identify potential implementation challenges, and develop strategies to overcome those difficulties.
- Conditions
- Stroke, Atrial Fibrillation
- Being tested
- Implantable Loop Recorder, Quality of life survey
- Keywords
- Implantable Loop Recorder, Anticoagulant, Stroke, Atrial fibrillation
- Medical subject headings
- Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Loop RecorderDevice
Patients will be implanted with a loop recorder. Patients will be given the choice of remove the loop recorder after the 12-months follow-up visit or at the end of its battery life (approximately 3 years)
Quality of life surveyOther
A quality of life survey will be performed at the end of the follow-up period. The survey will be done over the phone or in person if the follow-up visit is in person.
| Study group | Role | What they receive |
|---|---|---|
| Disclosure | Active comparator | Group A (disclosure arm): patients and physicians will be informed about all AF episodes identified on ILR lasting for ≥6 minutes. Receives: Device: Implantable Loop Recorder; Other: Quality of life survey |
| Non-Disclosure | Active comparator | Group B (non-disclosure arm): patients and physicians will be only informed about AF episodes identified on ILR lasting for ≥24h. This longer threshold is selected because of its association with increased risk of systemic embolism. Receives: Device: Implantable Loop Recorder; Other: Quality of life survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients enrolled at in 6 months
Median and interquartile range recruitment rate. We will use this rate to estimate the number of sites and enrollment duration required for a larger RCT.
Measured: 6 months
Secondary outcomes (9)
Screened, declined and dropouts.
- proportion and 95% confidence intervals (95% CI) of stroke patients needed to screen per patient invited to participate
- proportion and 95% CI of patients declining participation
- proportion and 95% CI of dropouts at the end of follow-up.
Measured: 2 years
Number of clinical endpoint events per diagnostic arm
The investigators will apply standard descriptive statistics to report the number of clinical endpoint events per diagnostic arm. The primary composite efficacy endpoint to be used in larger RCT is stroke recurrence (ischemic or hemorrhagic), systemic embolism, MACE (myocardial infarction and admission for decompensated AF or heart failure), and death. The primary safety endpoint will be major bleeding (ISTH definition).These data and results from prior studies will be used to estimate the final sample size and required number of sites for the larger RCT.
Measured: 2 years
Quality of life survey analysis
The investigators will perform a qualitative and quantitative analysis of the results of the ILR-specific quality of life survey. The analysis will be reviewed by the team and PWLE. We will use this information to improve patients' experiences in a larger RCT
Measured: 2 years
AF timing of diagnosis
The investigators will evaluate different measures of AF timing of diagnosis :Time to first AF diagnosis (DD:HH)
Measured: 2 years
AF burden (1)
The investigators will evaluate different measures of AF burden:
Total AF burden at 3, 6, and 12 months post-ILR insertion (sum of the duration of all AF episodes, HH:MM:SS).
Characterizing these measures will allow us to choose the best AF burden definition for a larger RCT.
Measured: 2 years
AF burden (2)
The investigators will evaluate different measures of AF burden:
Maximum duration of the longest AF episode. Characterizing these measures will allow us to choose the best AF burden definition for a larger RCT.
Measured: 2 years
AF burden (3)
The investigators will evaluate different measures of AF burden:
Relative AF burden (total AF burden/net monitoring time), (4) AF Pattern (number of AF episodes and time of occurrence), (5) Other ECG monitoring findings (premature atrial complexes, interatrial block, etc.). Characterizing these measures will allow us to choose the best AF burden definition for a larger RCT.
Measured: 2 years
AF burden (4)
The investigators will evaluate different measures of AF burden:
AF Pattern (number of AF episodes and time of occurrence). Characterizing these measures will allow us to choose the best AF burden definition for a larger RCT.
Measured: 2 years
AF burden (5)
The investigators will evaluate different measures of AF burden:
Other ECG monitoring findings (premature atrial complexes, interatrial block, etc.). Characterizing these measures will allow us to choose the best AF burden definition for a larger RCT.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study startNov 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionFeb 2025 (estimated)
Why it stopped: Withdrawn before enrollment because new clinical evidence made the study question no longer relevant.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luciano A. Sposato
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Responsible party
- Sponsor-investigator, Luciano A. Sposato, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Luciano A Sposato, MD, MBA, Principal investigator, LHSC - Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717504
- Sponsor's protocol ID
- 122103
- Acronym
- STARGATE
- Status last verified
- Sep 2026
- First submitted
- 13 Jan 2023
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STARGATE (Sweet spoT for cArdiac Rhythm monitorinG After sTrokE) Pilot Trial: A Pilot-feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05717504
- Acronym / sponsor ID
- STARGATE / 122103
- Conditions
- Stroke, Atrial Fibrillation
- Keywords
- Implantable Loop Recorder, Anticoagulant, Stroke, Atrial fibrillation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn before enrollment because new clinical evidence made the study question no longer relevant.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Luciano A. SposatoUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- Nov 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 8 Feb 2023 (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.
The goal of this clinical trial is to compare the use of long-term vs. shorter-term heart monitoring to detect atrial fibrillation after stroke.
Patients will be implanted with a loop recorder and will have study follow-up at 3-, 6- an 12-months after implantation.
The investigators will evaluate 24 patients, between the 3 centers, in the same way the investigators plan to evaluate a larger number of participants (>1000) in a future study. This will allow us to learn if such a study is possible, identify potential implementation challenges, and develop strategies to overcome those difficulties.
Detailed description
Atrial fibrillation (AF) is the most common heart rhythm disorder. Its name comes from the fibrillation (i.e. quivering) of the two upper chambers (atria) of the heart instead of a coordinated contraction, causing a rapid, irregular heart rate. This irregular contraction is ineffective, leading to the development clots in the heart. These clots can travel through the bloodstream until they get stuck in a brain artery. Millions of brain cells that depend on the oxygen supplied by the blocked artery die within minutes. This is known as a stroke. Strong blood thinners known as anticoagulants can lower stroke risk by 64% in AF patients when the AF is detected on an electrocardiogram (ECG) or if it lasts more than 24h on a heart monitor. Therefore, doctors use cardiac monitors to record the heartbeats of stroke patients for up to 3 years. It was historically thought, but not proven, that if AF was found in stroke patients, using anticoagulants could prevent a second stroke. However, recent information suggests that using cardiac monitors in stroke patients increases AF detection and anticoagulants prescription without a reduction in the number of new strokes. The failure to prevent a second stroke is likely the consequence of cardiac monitors sometimes detecting very short-duration AFs, which may have a low risk of stroke. If AFs last only for a few minutes or hours, anticoagulants may not be needed.
Patients with a stroke and not know atrial fibrillation will be implanted with a loop recorder and randomized in two groups (disclosure arm and non-disclosure arm). Patients will have phone follow-up visits at 3, 6 and 12 months after implantation. A quality-of-life survey will be performed at the last study visit.
This study will assess if it is possible to organize a large clinical trial comparing the use of long-term vs. shorter-term heart monitoring. The investigators will evaluate 24 patients, between the 3 centers, in the same way, the investigators plan to evaluate a larger number of participants (>1000) in a future study. This will allow us to learn if such a study is possible, identify potential implementation challenges, and develop strategies to overcome those difficulties.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disclosure | Active comparator | Device: Implantable Loop Recorder, Other: Quality of life surveyGroup A (disclosure arm): patients and physicians will be informed about all AF episodes identified on ILR lasting for ≥6 minutes. |
| Non-Disclosure | Active comparator | Device: Implantable Loop Recorder, Other: Quality of life surveyGroup B (non-disclosure arm): patients and physicians will be only informed about AF episodes identified on ILR lasting for ≥24h. This longer threshold is selected because of its association with increased risk of systemic embolism. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with cortical or subcortical, cryptogenic or non-cryptogenic acute ischemic stroke
Key exclusion criteria (4 listed)
- AF on 24-h inpatient or Holter monitoring
- Atrial or ventricular thrombus
- Other major-risk cardioembolic sources (e.g., mechanical valve)
- Other indications (e.g., venous thromboembolism) or contraindications for OACs.
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 |
|---|---|---|
| Implantable Loop RecorderPatients will be implanted with a loop recorder. Patients will be given the choice of remove the loop recorder after the 12-months follow-up visit or at the end of its battery life (approximately 3 years) | Device | Disclosure, Non-Disclosure |
| Quality of life surveyA quality of life survey will be performed at the end of the follow-up period. The survey will be done over the phone or in person if the follow-up visit is in person. | Other | Disclosure, Non-Disclosure |
Primary outcome
Number of patients enrolled at in 6 months
Time frame: 6 months
Median and interquartile range recruitment rate. We will use this rate to estimate the number of sites and enrollment duration required for a larger RCT.
9 secondary outcomes
Screened, declined and dropouts.
Time frame: 2 years
Number of clinical endpoint events per diagnostic arm
Time frame: 2 years
Quality of life survey analysis
Time frame: 2 years
AF timing of diagnosis
Time frame: 2 years
AF burden (1)
Time frame: 2 years
AF burden (2)
Time frame: 2 years
AF burden (3)
Time frame: 2 years
AF burden (4)
Time frame: 2 years
AF burden (5)
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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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.
Luciano A Sposato, MD, MBA principal investigator
LHSC - Western University
Questions about this trial
What is this clinical trial studying?
A study testing Implantable Loop Recorder and Quality of life survey in people with Stroke and Atrial Fibrillation, run by Luciano A. Sposato.
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 1 inclusion and 4 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: withdrawn, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Number of patients enrolled at in 6 months (time frame: 6 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 18 Sep 2026.