StrokeCMACSNCT00932425
Long-term Cardiac Monitoring After Cryptogenic Stroke (CMACS)
A study testing Cardionet Mobile Cardiac Outpatient Telemetry (MCOT) in people with Stroke, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Long-term Cardiac Monitoring After Cryptogenic Stroke (CMACS): A Pilot Randomized Trial
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.
- Conditions
- Stroke
- Being tested
- Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)
- Keywords
- Stroke, Cryptogenic, Cardioembolic, 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.
Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)Device
Patients will be assigned to wear the telemetry device for 21 days
| Study group | Role | What they receive |
|---|---|---|
| Outpatient cardiac monitoring | Experimental | Patients will be assigned to wear a portable outpatient cardiac telemetry device for 21 days Receives: Device: Cardionet Mobile Cardiac Outpatient Telemetry (MCOT) |
| Control | No intervention | Patients will be discharged home with standard clinical follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 21 days
Secondary outcomes (3)
Diagnosis of Atrial Fibrillation
Measured: 90 days
Diagnosis of Atrial Fibrillation
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wade Smith, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932425
- Sponsor's protocol ID
- CMACS
- Acronym
- CMACS
- Status last verified
- Feb 2015
- First submitted
- 1 Jul 2009
- Last updated
- 27 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Cardiac Monitoring After Cryptogenic Stroke (CMACS): A Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT00932425
- Acronym / sponsor ID
- CMACS / CMACS
- Conditions
- Stroke
- Keywords
- Stroke, Cryptogenic, Cardioembolic, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 3 Jul 2009 (estimated)
- Results
- Posted 27 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outpatient cardiac monitoring | Experimental | Device: Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)Patients will be assigned to wear the telemetry device for 21 days | Device | Outpatient cardiac monitoring |
Primary outcome
Completion of Clinical Follow-up as a Measure of Feasibility
Time frame: 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
Time frame: 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.
3 secondary outcomes
Diagnosis of Atrial Fibrillation
Time frame: 90 days
Diagnosis of Atrial Fibrillation
Time frame: 1 year
Recurrent Stroke or TIA
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Wade Smith, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardionet Mobile Cardiac Outpatient Telemetry (MCOT) in people with Stroke, run by University of California, San Francisco at 1 site in United States.
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 3 inclusion and 8 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 27 Feb 2015. 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 United States. 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?
Yes. Results are posted in the registry (first posted 27 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Completion of Clinical Follow-up as a Measure of Feasibility (time frame: 1 year). The study lists 2 primary outcomes in all. 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 27 Feb 2015.