StrokeNCT04644679
Monitoring Strategies for the Detection of Atrial Fibrillation in Patients with Cryptogenic Stroke
A study testing 7-day electrocardiographic monitoring and 48-hr electrocardiographic monitoring in people with Stroke and Atrial Fibrillation, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
Randomized clinical trial comparing two monitoring strategies, the use of a 48-hour Holter (routine care branch) and an event recorder for 7 days (intervention branch). Patients admitted for cryptogenic stroke will be included. 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?
- 7-day electrocardiographic monitoring and 48-hr electrocardiographic monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteArgentina
- Study dates
- 2 Nov 2020to 7 Oct 2021
- 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
- All patients who have studies that classify stroke or TIA as cryptogenic and who can carry out monitoring for 48 hours or 7 days will be included.
- Age ≥ 18 years
Who cannot join
- History of atrial fibrillation (or atrial flutter) documented.
- Patients who already have an event recorder in place, permanent pacemaker, or implantable cardioverter-defibrillator
- Evidence of lacunar infarction.
- Hemorrhagic stroke
- Patient for palliative care
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Italiano de Buenos Aires
Buenos Aires, C.a.b.a, C1199
About this study
Official title: 48-hour Versus 7-day Monitoring for the Detection of Atrial Fibrillation in Patients with Cryptogenic Stroke
Randomized clinical trial comparing two monitoring strategies, the use of a 48-hour Holter (routine care branch) and an event recorder for 7 days (intervention branch).
Patients admitted for cryptogenic stroke will be included. Enrollment and randomization of patients will be carried out during the index case hospitalization, while follow-up will be done on an outpatient basis until day 7.
Read the detailed description
Once the diagnose of cryptogenic stroke have been carried out, informed consent will be taken and participants will be randomized to 48-hour monitoring arm or 7-day monitoring arm, followed by discharge from hospital.
- Conditions
- Stroke, Atrial Fibrillation
- Being tested
- 7-day electrocardiographic monitoring, 48-hr electrocardiographic monitoring
- 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.
7-day electrocardiographic monitoringDiagnostic test
7-day external electrocardiographic monitoring
48-hr electrocardiographic monitoringDiagnostic test
48-hr external electrocardiographic monitoring
| Study group | Role | What they receive |
|---|---|---|
| 48-hr | Active comparator | 48-hr electrocardiographic monitoring Receives: Diagnostic Test: 48-hr electrocardiographic monitoring |
| 7-day | Experimental | 7-day electrocardiographic monitoring Receives: Diagnostic Test: 7-day electrocardiographic monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation
Detection of one episode of atrial fibrillation or atrial flutter >30 seconds up to 7 days
Measured: 7 days
Secondary outcomes (1)
Supraventricular arrhythmia
Count of beats per day of non-sustained irregular atrial tachyarrhythmia or supraventricular extrasystoles up to 7 days
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start2 Nov 2020
- Primary completion30 Sep 2021
- Study completion7 Oct 2021
Why it stopped: Poor enrollment rate
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EMILIANO ROSSI, Hospital Italiano de Buenos Aires
- Investigators
- Gustavo Maid, MD, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644679
- Sponsor's protocol ID
- 5767
- Status last verified
- Nov 2020
- First submitted
- 30 Sep 2020
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 48-hour Versus 7-day Monitoring for the Detection of Atrial Fibrillation in Patients with Cryptogenic Stroke
- ClinicalTrials.gov ID
- NCT04644679
- Acronym / sponsor ID
- 5767
- Conditions
- Stroke, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment rate
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 7 Oct 2021 (actual)
- First posted
- 25 Nov 2020 (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.
Randomized clinical trial comparing two monitoring strategies, the use of a 48-hour Holter (routine care branch) and an event recorder for 7 days (intervention branch).
Patients admitted for cryptogenic stroke will be included. Enrollment and randomization of patients will be carried out during the index case hospitalization, while follow-up will be done on an outpatient basis until day 7.
Detailed description
Once the diagnose of cryptogenic stroke have been carried out, informed consent will be taken and participants will be randomized to 48-hour monitoring arm or 7-day monitoring arm, followed by discharge from hospital.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 48-hr | Active comparator | Diagnostic Test: 48-hr electrocardiographic monitoring48-hr electrocardiographic monitoring |
| 7-day | Experimental | Diagnostic Test: 7-day electrocardiographic monitoring7-day electrocardiographic monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients who have studies that classify stroke or TIA as cryptogenic and who can carry out monitoring for 48 hours or 7 days will be included.
- Age ≥ 18 years
Key exclusion criteria (5 listed)
- History of atrial fibrillation (or atrial flutter) documented.
- Patients who already have an event recorder in place, permanent pacemaker, or implantable cardioverter-defibrillator
- Evidence of lacunar infarction.
- Hemorrhagic stroke
- Patient for palliative care
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 |
|---|---|---|
| 7-day electrocardiographic monitoring7-day external electrocardiographic monitoring | Diagnostic test | 7-day |
| 48-hr electrocardiographic monitoring48-hr external electrocardiographic monitoring | Diagnostic test | 48-hr |
Primary outcome
Atrial fibrillation
Time frame: 7 days
Detection of one episode of atrial fibrillation or atrial flutter >30 seconds up to 7 days
1 secondary outcome
Supraventricular arrhythmia
Time frame: 7 days
Results and safety
The study was stopped early (reason given: Poor enrollment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Gustavo Maid, MD principal investigator
Hospital Italiano de Buenos Aires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 7-day electrocardiographic monitoring and 48-hr electrocardiographic monitoring in people with Stroke and Atrial Fibrillation, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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 5 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: stopped early, as of the sponsor's last update on 21 Nov 2024. 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 Argentina. 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 was stopped early (reason given: Poor enrollment rate). Results are not available in the source record.
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?
Atrial fibrillation (time frame: 7 days). 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 21 Nov 2024.