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Atrial fibrillation (AF) is a common and treatable cause of ischemic stroke, but it can be paroxysmal and asymptomatic, and therefore difficult to detect. Patients with stroke routinely undergo 24 hours of continuous cardiac telemetry during hospitalization for stroke as a means of excluding AF. Small studies indicate that extending the duration of monitoring with portable outpatient telemetry devices detects more cases of AF. However, these studies are small and lack control groups, and cannot demonstrate that prolonged cardiac monitoring detects more cases of AF than routine clinical follow-up. The investigators therefore propose a pilot study to determine the feasibility of randomizing patients to prolonged cardiac monitoring or routine clinical follow-up. The investigators will enroll 40 consecutive adult patients seen at the University of California at San Francisco (UCSF) Neurovascular service with cryptogenic stroke or high-risk TIA (ABCD2 score 4 or greater). Enrolled patients will be randomized in a 1:1 fashion. Group A will be assigned to wear an ambulatory cardiac event monitor for 21 days. Group B will be discharged home without a monitor and will serve as controls during routine clinical follow-up. The investigators' primary outcome will be feasibility, defined as more than 80% of randomized patients completing full clinical follow-up and more than 70% of cardiac monitoring if applicable. The investigators' secondary outcomes will be diagnoses of AF at 90 days and 1 year and diagnoses of recurrent stroke at 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outpatient cardiac monitoring | Experimental | Patients will be assigned to wear a portable outpatient cardiac telemetry device for 21 days |
|
| Control | No Intervention | Patients will be discharged home with standard clinical follow-up |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardionet Mobile Cardiac Outpatient Telemetry (MCOT) | Device | Patients will be assigned to wear the telemetry device for 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Completion of Clinical Follow-up as a Measure of Feasibility | Feasibility was defined as 90% or more of randomized patients completing full clinical follow-up and 70% or more completion of assigned cardiac monitoring if applicable | 1 year |
| Completion of Assigned Monitoring as a Measure of Feasibility | Feasibility criteria included more than 70% completion of cardiac monitoring if applicable. Patients in the Monitoring arm were assigned to wear a Cardionet mobile cardiac outpatient telemetry monitor for 21 days. Outpatient monitoring began 22 days (+/- 12 days) after symptom onset. | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnosis of Atrial Fibrillation | 90 days | |
| Diagnosis of Atrial Fibrillation | 1 year | |
| Recurrent Stroke or TIA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wade Smith, MD, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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40 patients were enrolled between October 29, 2009 and May 24, 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Outpatient Cardiac Monitoring | Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days |
| FG001 | Control | Patients discharged home with standard clinical follow-up |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
per protocol
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| ID | Title | Description |
|---|---|---|
| BG000 | Outpatient Cardiac Monitoring | Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Completion of Clinical Follow-up as a Measure of Feasibility | Feasibility was defined as 90% or more of randomized patients completing full clinical follow-up and 70% or more completion of assigned cardiac monitoring if applicable | Posted | Number | participants | 1 year |
|
1 year
Participants were assessed for adverse events attributable to the intervention during the monitoring period, and for recurrent stroke or TIA at 3 months and 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Outpatient Cardiac Monitoring | Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Contact dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment | One participant in the monitoring group had contact dermatitis, which we classified as an AE attributable to the intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wade Smith, MD, PhD | University of California San Francisco | 415-353-8897 | smithw@neurology.ucsf.edu |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Patients and their primary physicians or neurologists were contacted at 3 months and 1 year after discharge and reported clinical diagnoses of recurrent stroke or TIA using validated questionnaires. Reported events were verified by review of relevant medical records. |
| 1 year |
Patients discharged home with standard clinical follow-up |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Diagnosis of Atrial Fibrillation | 2 patients in the control arm did not have a full 90 days of assessment (see Participant Flow) | Posted | Number | participants | 90 days |
|
|
|
| Secondary | Diagnosis of Atrial Fibrillation | 2 participants in the Control arm were followed for less than 90 days | Posted | Number | participants | 1 year |
|
|
|
| Secondary | Recurrent Stroke or TIA | Patients and their primary physicians or neurologists were contacted at 3 months and 1 year after discharge and reported clinical diagnoses of recurrent stroke or TIA using validated questionnaires. Reported events were verified by review of relevant medical records. | Posted | Number | participants | 1 year |
|
|
|
| Primary | Completion of Assigned Monitoring as a Measure of Feasibility | Feasibility criteria included more than 70% completion of cardiac monitoring if applicable. Patients in the Monitoring arm were assigned to wear a Cardionet mobile cardiac outpatient telemetry monitor for 21 days. Outpatient monitoring began 22 days (+/- 12 days) after symptom onset. | Only patients in the monitoring arm were assessed for compliance with assigned monitoring | Posted | Number | participants | 21 days |
|
|
|
| 1 |
| 20 |
| 1 |
| 20 |
| EG001 | Control | Patients discharged home with standard clinical follow-up | 3 | 18 | 0 | 0 |
| TIA | Vascular disorders | Systematic Assessment |
|
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |