StrokeNCT01325545
Detection of Occult Paroxysmal Atrial Fibrillation After Stroke Using Prolonged Ambulatory Cardiac Monitoring
An observational study of Stroke and Atrial Fibrillation, run by Mayo Clinic.
Trial summary
About one-third of patients with stroke have no documented cause for the cerebrovascular event (known as cryptogenic strokes). Atrial fibrillation is a common cause of stroke, but when transient (paroxysmal) it may remain undiagnosed. 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?
- Mobile cardiac rhythm monitoring
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Mar 2011
- Phase
- Observational
- 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
Study population: Patients with stroke or TIA confirmed by a vascular neurologist within previous 3 months with complete evaluation for stroke causes according to current standards.
Who may be able to join
- Stroke or TIA within previous 3 months
- Stroke work up including: EKG, serum lipids, serum TSH, TTE or TEE, brain CT and/or MRI, Vascular Evaluation of head and neck using any combination of ultrasound, MRA, CTA, and conventional angiography
Who cannot join
- Documented history of atrial fibrillation or flutter
- PFO closure planned before conclusion of the monitoring period
- Incomplete stroke work up
About this study
Official title: Detection of Occult Paroxysmal Atrial Fibrillation in Patients With Cryptogenic Stroke or TIA Using 21-Day Mobile Cardiac Outpatient Telemetry
About one-third of patients with stroke have no documented cause for the cerebrovascular event (known as cryptogenic strokes). Atrial fibrillation is a common cause of stroke, but when transient (paroxysmal) it may remain undiagnosed. Recent data suggest that occult paroxysmal atrial fibrillation may be identified in patients with cryptogenic strokes using prolonged ambulatory cardiac rhythm monitors.
The investigators designed this study pursuing the following goals:
- To determine the prevalence of occult paroxysmal atrial fibrillation in patients with cryptogenic stroke using long-term mobile cardiac outpatient telemetry.
- To compare this prevalence to that found in a control group with stroke of known, non-cardioembolic cause.
- To look for clinical, laboratory, echocardiographic, and imaging data that serve as risk factors for occult paroxysmal atrial fibrillation in patients with cryptogenic stroke.
- To examine the utility of mobile cardiac outpatient telemetry, a relatively new diagnostic tool, in the evaluation of patients with cryptogenic stroke.
- Conditions
- Stroke, Atrial Fibrillation
- Being tested
- Mobile cardiac rhythm monitoring
- Keywords
- 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.
Mobile cardiac rhythm monitoringOther
Continuous ambulatory cardiac rhythm monitoring using the CardioNet MCOT device
| Study group | Role | What they receive |
|---|---|---|
| Cryptogenic stroke | Patients with stroke of unknown cause after comprehensive conventional evaluation Receives: Other: Mobile cardiac rhythm monitoring | |
| Stroke of known cause | Patients with stroke of known cause determined by comprehensive conventional evaluation Receives: Other: Mobile cardiac rhythm monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Atrial Fibrillation
Documented presence of atrial fibrillation detected by the monitoring device and independently confirmed by a board-certified cardiologist
Measured: 21 days
Secondary outcomes (5)
Time to first episode of atrial fibrillation
Measured: Within monitoring period (3 weeks)
Atrial Fibrillation Load
Total time that the patient had atrial fibrillation during the monitoring period
Measured: Within monitoring period (3 weeks)
Adverse events related to mobile cardiac monitoring
Measured: 21 days
Symptomatic status of episode of atrial fibrillation
Presence or absence of symptoms related to the occurrence of paroxysmal atrial fibrillation
Measured: 21 days
Longest duration of episode of atrial fibrillation
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startApr 2009
- Primary completionMar 2011
- Study completionMar 2011
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 StrokeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Cardionet
- Responsible party
- Principal investigator, Alejandro Rabinstein, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325545
- Sponsor's protocol ID
- 08-003788
- Status last verified
- Dec 2011
- First submitted
- 28 Mar 2011
- Last updated
- 23 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Baturova MA, Sheldon SH, Carlson J, Brady PA, Lin G, Rabinstein AA, Friedman PA, Platonov PG. Electrocardiographic and Echocardiographic predictors of paroxysmal atrial fibrillation detected after ischemic stroke. BMC Cardiovasc Disord. 2016 Nov 3;16(1):209. doi: 10.1186/s12872-016-0384-2.
PubMed 27809773
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Occult Paroxysmal Atrial Fibrillation in Patients With Cryptogenic Stroke or TIA Using 21-Day Mobile Cardiac Outpatient Telemetry
- ClinicalTrials.gov ID
- NCT01325545
- Acronym / sponsor ID
- 08-003788
- Conditions
- Stroke, Atrial Fibrillation
- Keywords
- Stroke, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Cardionet
- Study start
- Apr 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 29 Mar 2011 (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.
About one-third of patients with stroke have no documented cause for the cerebrovascular event (known as cryptogenic strokes). Atrial fibrillation is a common cause of stroke, but when transient (paroxysmal) it may remain undiagnosed. Recent data suggest that occult paroxysmal atrial fibrillation may be identified in patients with cryptogenic strokes using prolonged ambulatory cardiac rhythm monitors.
The investigators designed this study pursuing the following goals:
- To determine the prevalence of occult paroxysmal atrial fibrillation in patients with cryptogenic stroke using long-term mobile cardiac outpatient telemetry.
- To compare this prevalence to that found in a control group with stroke of known, non-cardioembolic cause.
- To look for clinical, laboratory, echocardiographic, and imaging data that serve as risk factors for occult paroxysmal atrial fibrillation in patients with cryptogenic stroke.
- To examine the utility of mobile cardiac outpatient telemetry, a relatively new diagnostic tool, in the evaluation of patients with cryptogenic stroke.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryptogenic stroke | – | Other: Mobile cardiac rhythm monitoringPatients with stroke of unknown cause after comprehensive conventional evaluation |
| Stroke of known cause | – | Other: Mobile cardiac rhythm monitoringPatients with stroke of known cause determined by comprehensive conventional evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stroke or TIA confirmed by a vascular neurologist within previous 3 months with complete evaluation for stroke causes according to current standards.
Key inclusion criteria (2 listed)
- Stroke or TIA within previous 3 months
- Stroke work up including: EKG, serum lipids, serum TSH, TTE or TEE, brain CT and/or MRI, Vascular Evaluation of head and neck using any combination of ultrasound, MRA, CTA, and conventional angiography
Key exclusion criteria (3 listed)
- Documented history of atrial fibrillation or flutter
- PFO closure planned before conclusion of the monitoring period
- Incomplete stroke work up
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 |
|---|---|---|
| Mobile cardiac rhythm monitoringContinuous ambulatory cardiac rhythm monitoring using the CardioNet MCOT device | Other | Cryptogenic stroke, Stroke of known cause |
Primary outcome
Detection of Atrial Fibrillation
Time frame: 21 days
Documented presence of atrial fibrillation detected by the monitoring device and independently confirmed by a board-certified cardiologist
5 secondary outcomes
Time to first episode of atrial fibrillation
Time frame: Within monitoring period (3 weeks)
Atrial Fibrillation Load
Time frame: Within monitoring period (3 weeks)
Adverse events related to mobile cardiac monitoring
Time frame: 21 days
Symptomatic status of episode of atrial fibrillation
Time frame: 21 days
Longest duration of episode of atrial fibrillation
Time frame: 21 days
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 23 Dec 2011.
- Derived from this study: PubMed 27809773Baturova MA, Sheldon SH, Carlson J, Brady PA, Lin G, Rabinstein AA, Friedman PA, Platonov PG. Electrocardiographic and Echocardiographic predictors of paroxysmal atrial fibrillation detected after ischemic stroke. BMC Cardiovasc Disord. 2016 Nov 3;16(1):209. doi: 10.1186/s12872-016-0384-2.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Atrial Fibrillation, run by Mayo Clinic.
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 3 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 23 Dec 2011. 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 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 of Atrial Fibrillation (time frame: 21 days). 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 NCT01325545, 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 23 Dec 2011.