Stroke
Conditions
Keywords
Stroke, Cryptogenic, Cardioembolic, Atrial Fibrillation
Brief summary
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.
Interventions
DEVICECardionet Mobile Cardiac Outpatient Telemetry (MCOT)
Patients will be assigned to wear the telemetry device for 21 days
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Seen at UCSF Medical Center for cryptogenic stroke or high-risk TIA * Onset of stroke or TIA symptoms within the previous 60 days
Exclusion criteria
* Definite small-vessel etiology by history or imaging * Source found on vascular imaging of possible culprit vessels * Source found by echocardiography (TEE not required) * History of atrial fibrillation * Atrial fibrillation on admission ECG * Atrial fibrillation detected by inpatient cardiac telemetry (at least 24 hours required) * Obvious culpable systemic illness such as endocarditis * Patient unable to provide written, informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of Clinical Follow-up as a Measure of Feasibility | 1 year | 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 |
| Completion of Assigned Monitoring as a Measure of Feasibility | 21 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnosis of Atrial Fibrillation | 90 days | — |
| Recurrent Stroke or TIA | 1 year | 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. |
Countries
United States
Participant flow
Recruitment details
40 patients were enrolled between October 29, 2009 and May 24, 2011
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Control Patients discharged home with standard clinical follow-up | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Outpatient Cardiac Monitoring | Control | Total |
|---|---|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 15 | 69 years STANDARD_DEVIATION 9 | 67 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 8 Participants | 9 Participants | 17 Participants |
| Sex: Female, Male Male | 12 Participants | 11 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 20 | 0 / 0 |
| serious Total, serious adverse events | 1 / 20 | 3 / 18 |
Outcome results
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.
Time frame: 21 days
Population: Only patients in the monitoring arm were assessed for compliance with assigned monitoring
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Outpatient Cardiac Monitoring | Completion of Assigned Monitoring as a Measure of Feasibility | 15 participants |
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
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Outpatient Cardiac Monitoring | Completion of Clinical Follow-up as a Measure of Feasibility | 20 participants |
| Control | Completion of Clinical Follow-up as a Measure of Feasibility | 18 participants |
Secondary
Diagnosis of Atrial Fibrillation
Time frame: 90 days
Population: 2 patients in the control arm did not have a full 90 days of assessment (see Participant Flow)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Outpatient Cardiac Monitoring | Diagnosis of Atrial Fibrillation | 0 participants |
| Control | Diagnosis of Atrial Fibrillation | 0 participants |
Secondary
Diagnosis of Atrial Fibrillation
Time frame: 1 year
Population: 2 participants in the Control arm were followed for less than 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Outpatient Cardiac Monitoring | Diagnosis of Atrial Fibrillation | 0 participants |
| Control | Diagnosis of Atrial Fibrillation | 0 participants |
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.
Time frame: 1 year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Outpatient Cardiac Monitoring | Recurrent Stroke or TIA | Stroke | 0 participants |
| Outpatient Cardiac Monitoring | Recurrent Stroke or TIA | TIA | 1 participants |
| Control | Recurrent Stroke or TIA | Stroke | 1 participants |
| Control | Recurrent Stroke or TIA | TIA | 2 participants |