NeuropathologySPIDERFLASHNCT02778321
Prospective Study Evaluating the Interest of Long-term Cardiac Recording in Cerebral Infarction
A study testing Uses of SpiderFlash monitor in people with Neuropathology, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Cerebral infarction (CI) can be linked to atherosclerosis of large vessels, occlusion of small vessels intracerebral (gaps), a cardioembolic disease or other rare causes. However, up to 40% of CI remains unexplained after a thorough diagnostic workup. They are called cryptogenic IC. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Neuropathology
- What is being tested?
- Uses of SpiderFlash monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteFrance
- Study dates
- 17 Nov 2014to 24 Apr 2019
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ICU Neurovascular hospitalized for cerebral infarction CI
- No history of atrial fibrillation or flutter
- No hypercoagulable
- Patient unopposed and capable of carrying 21-day monitoring
Who cannot join
- Patients with severe cognitive impairment that can not keep SpiderFlash® for 21 days
- Previous history of AF or flutter
- Significant artery stenosis requiring specific treatment (endarterectomy or stenting)
- FA on arrival at the ICU Neurovascular
- Trucks of a pacemaker or cardiac defibrillator
- Deadline for the CI more than 10 days
- Other sources of cardiac embolism
- Pejorative prognosis (mRS≥5)
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Cerebral infarction (CI) can be linked to atherosclerosis of large vessels, occlusion of small vessels intracerebral (gaps), a cardioembolic disease or other rare causes. However, up to 40% of CI remains unexplained after a thorough diagnostic workup. They are called cryptogenic IC.
Atrial fibrillation (AF) is the cause of 25% of the CI but it is recognized that episodes of paroxysmal AF, asymptomatic and unnoticed, may be responsible for a portion of the IC cryptogenic pace. Recognition of these episodes is of great importance since they have the same risk embolic the FA continues [1, 2] and motivate anticoagulant therapy startup.
Read more
Several recording techniques heart rate were evaluated after the IC for detecting the AF. Their profitability increases with the duration of the recording: about 3% for a typical 24-hour Holter, the AF detection rate increases to 6% for a 7-day surveillance period, to 12-23% for 30 days and 17-26% with implantable recorders long.
Otherwise brief rhythmic heart abnormalities can be detected with the waning of an CI without the significance of these episodes is known.
Investigators decided to conduct this study because there is no prospective study of good quality with a sufficient number of patients that evaluated the interest of a non-invasive recording of long duration. The only randomized CRYSTAL AF is used for invasive subcutaneous implantable monitor (Reveal XT).
To clarify the significance of arrhythmias and because the presence of several causes is common after 65, investigators propose to record all patients hospitalized for HF.
Read the detailed description
Main objective / secondary The objectives of our study were to assess the prevalence of AF in patients hospitalized for an IC and to detect and describe all heart rhythmic abnormalities reported immediately to the waning of an IC cryptogenic (ie without cause or without obvious cause ) for non-invasive cardiac monitoring.
- The primary endpoint: number of patients in whom it was found AF
- Secondary Endpoints: typical patient subgroups in which it was discovered AF and other rhythm abnormalities; Description of the population under prescribed anticoagulation following SpiderFlash® recordings, cardiac ultrasound parameters (including the surface of the left atrium and the index of the function of the mitral annulus) and rhythmic anomalies in groups with atheromatous and cryptogenic stroke.
Inclusion / non inclusion Inclusion criteria
- Patients over 65 years, hospitalized for cerebral infarction ICU Neurovascular
- No history of atrial fibrillation or flutter
- No hypercoagulable
- Patient unopposed and capable of carrying 21-day monitoring Exclusion criteria
- Patients with severe cognitive impairment that can not keep SpiderFlash® for 21 days
- Previous history of AF or flutter
- Significant artery stenosis requiring specific treatment (endarterectomy or stenting)
- FA on arrival at the ICU Neurovascular
- Trucks of a pacemaker or cardiac defibrillator
- Deadline for the IC more than 10 days
- Other sources of cardiac embolism
- Pejorative prognosis (mRS≥5)
The IC is defined as a central focal neurological deficit of sudden onset and is confirmed by a CT scan or MRI.
The minimum workup includes ECG monitoring by continuous cardiac monitoring, transthoracic echocardiography (transesophageal +/-) and a Doppler ultrasound of the supra-aortic trunks and transcranial.
Methodology :
This is an interventional study in routine care, prospective, single-center, blinded for heart rhythm specialist.
Investigators will use the SpiderFlash®, Holter monitor (technology "Secure Data") to have a storage capacity enabling a registration up to 30 days with sufficient autonomy. The SpiderFlash® is currently registered in the GHPSJ for use in various directions including through cryptogenic cerebral infarction.
The data collected will (see Annex 2 CRF):
- Demographic data: age, sex, vascular risk factors, antithrombotic therapy at the entrance, history of Transient Ischemic Accident (TIA) or CI
- Data on the IC: arterial territory, side (right / left) or insular cortex reached severity (NIHSS score) made further examinations, echocardiography result, become during hospitalization (mRS)
- Monitoring Results scope ICU Neurovascular.
- Presence palpitations
- Treatment influencing the rate (beta-blockers or antiarrhythmic)
- Data on cardiac monitoring: time, duration, number of detected events
A questionnaire evaluating the safety of SpiderFlash® will be given to the patient (Appendix 3) and the results of Holter will be communicated at the end of the recording (as will be shown them in the Circular).
During a screening period of one month, 33 eligible patients over 65 admitted to CI 17 patients (51%) were identified including 9 with cryptogenic CI 8 and having either a non-significant atheroma is a rhythm disorder ( ESSV or atrial hyperexcitability). Among 16 ineligible patients, 4 had severe dementia, 11 had previous FA to 1 significant extracranial stenosis.
The patient recruitment period will be one year for one further year or two-year inclusion period to recruit 200 patients originally planned to study (the first year of inclusion has allowed us to include 73 patients) The data will be entered manually on paper CRF and Excel anonymized so not including the patient identifiers (name or IPP).
The originality of our study:
- Prospective study
- Inclusion of CI cryptogenic and non cryptogenic
- Laying SpiderFlash® early after CI
- Correlation with cardiac ultrasound parameters
- Analysis by the blind rhythm specialist (will not be aware of patient characteristics)
- Changing all events while recording (not just the passages FA)
- Questionnaire "comfort" given to the patient
Investigators specify that the data on the comfort of the patient questionnaire will not be transferred to the company Sorin; this questionnaire meets strict medical interest (including estimate the patient's ability to carry equipment during the full period).
Ethics / Regulatory:
The data processing will be carried out locally on the GHPSJ of anonymized way. The inclusion of patients will occur after patient information collection and its non-opposition traced in his medical records (Appendix 1). The data will be entered by the vascular neurologist anonymously. All patient information will remain confidential.
partnerships:
The Sorin company, manufacturer of SpiderFlash® provide (loan) material in sufficient quantity for the duration of the study.
The GHPSJ: neurologist time and CRA The SELARL rythmo: time heart rhythm specialists
- Conditions
- Neuropathology
- Being tested
- Uses of SpiderFlash monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uses of SpiderFlash monitorDevice
Investigators will use the SpiderFlash®, Holter monitor (technology "Secure Data") to have a storage capacity enabling a registration up to 30 days with sufficient autonomy.
The data collected :
- Demographic data: age, sex, vascular risk factors, antithrombotic therapy at the entrance, history of Transient Ischemic Accident (TIA) or Cerebral infarct (CI)
- Data on the CI:
- Monitoring Results scope ICU Neurovascular.
- Presence palpitations
- Treatment influencing the rate (beta-blockers or antiarrhythmic)
- Data on cardiac monitoring:
A questionnaire evaluating the safety of SpiderFlash® will be given to the patient and the results of Holter will be communicated at the end of the recording to the blinded rhythm specialist
| Study group | Role | What they receive |
|---|---|---|
| Uses of SpiderFlash monitor | Other | The intervention corresponds to the use of Spiderflash as Holter monitor. Investigators will use the SpiderFlash®, Holter monitor (technology "Secure Data") to have a storage capacity enabling a registration up to 30 days with sufficient autonomy.
A questionnaire evaluating the safety of SpiderFlash® will be given to the patient and the results of Holter will be communicated at the end of the recording to the blinded rhythm specialist. Receives: Device: Uses of SpiderFlash monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac monitoring
Data concerning cardiac monitoring: time, duration, number of detected events
Measured: During the 30 days of monitoring
Secondary outcomes (2)
NIHSS score
Diagnostic and stroke severity score measures the intensity of neurological signs to monitor their progress and estimate their severity.
Measured: Day 1
Treatment influencing the rate
Treatment influencing the rate (beta blockers or antiarrhythmic drugs)
Measured: During the 30 days of monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study start17 Nov 2014
- Primary completion31 Jul 2018
- Study completion24 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuropathologyStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathieu ZUBER, Principal investigator, Groupe Hospitalier Paris Saint-Joseph (FRANCE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778321
- Sponsor's protocol ID
- SPIDERFLASH
- Acronym
- SPIDERFLASH
- Status last verified
- Apr 2019
- First submitted
- 9 May 2016
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Evaluating the Interest of Long-term Cardiac Recording in Cerebral Infarction
- ClinicalTrials.gov ID
- NCT02778321
- Acronym / sponsor ID
- SPIDERFLASH / SPIDERFLASH
- Conditions
- Neuropathology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 17 Nov 2014 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 24 Apr 2019 (actual)
- First posted
- 19 May 2016 (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.
Cerebral infarction (CI) can be linked to atherosclerosis of large vessels, occlusion of small vessels intracerebral (gaps), a cardioembolic disease or other rare causes. However, up to 40% of CI remains unexplained after a thorough diagnostic workup. They are called cryptogenic IC.
Atrial fibrillation (AF) is the cause of 25% of the CI but it is recognized that episodes of paroxysmal AF, asymptomatic and unnoticed, may be responsible for a portion of the IC cryptogenic pace. Recognition of these episodes is of great importance since they have the same risk embolic the FA continues [1, 2] and motivate anticoagulant therapy startup.
Several recording techniques heart rate were evaluated after the IC for detecting the AF. Their profitability increases with the duration of the recording: about 3% for a typical 24-hour Holter, the AF detection rate increases to 6% for a 7-day surveillance period, to 12-23% for 30 days and 17-26% with implantable recorders long.
Otherwise brief rhythmic heart abnormalities can be detected with the waning of an CI without the significance of these episodes is known.
Investigators decided to conduct this study because there is no prospective study of good quality with a sufficient number of patients that evaluated the interest of a non-invasive recording of long duration. The only randomized CRYSTAL AF is used for invasive subcutaneous implantable monitor (Reveal XT).
To clarify the significance of arrhythmias and because the presence of several causes is common after 65, investigators propose to record all patients hospitalized for HF.
Detailed description
Main objective / secondary The objectives of our study were to assess the prevalence of AF in patients hospitalized for an IC and to detect and describe all heart rhythmic abnormalities reported immediately to the waning of an IC cryptogenic (ie without cause or without obvious cause ) for non-invasive cardiac monitoring.
- The primary endpoint: number of patients in whom it was found AF
- Secondary Endpoints: typical patient subgroups in which it was discovered AF and other rhythm abnormalities; Description of the population under prescribed anticoagulation following SpiderFlash® recordings, cardiac ultrasound parameters (including the surface of the left atrium and the index of the function of the mitral annulus) and rhythmic anomalies in groups with atheromatous and cryptogenic stroke.
Inclusion / non inclusion Inclusion criteria
- Patients over 65 years, hospitalized for cerebral infarction ICU Neurovascular
- No history of atrial fibrillation or flutter
- No hypercoagulable
- Patient unopposed and capable of carrying 21-day monitoring Exclusion criteria
- Patients with severe cognitive impairment that can not keep SpiderFlash® for 21 days
- Previous history of AF or flutter
- Significant artery stenosis requiring specific treatment (endarterectomy or stenting)
- FA on arrival at the ICU Neurovascular
- Trucks of a pacemaker or cardiac defibrillator
- Deadline for the IC more than 10 days
- Other sources of cardiac embolism
- Pejorative prognosis (mRS≥5)
The IC is defined as a central focal neurological deficit of sudden onset and is confirmed by a CT scan or MRI.
The minimum workup includes ECG monitoring by continuous cardiac monitoring, transthoracic echocardiography (transesophageal +/-) and a Doppler ultrasound of the supra-aortic trunks and transcranial.
Methodology :
This is an interventional study in routine care, prospective, single-center, blinded for heart rhythm specialist.
Investigators will use the SpiderFlash®, Holter monitor (technology "Secure Data") to have a storage capacity enabling a registration up to 30 days with sufficient autonomy. The SpiderFlash® is currently registered in the GHPSJ for use in various directions including through cryptogenic cerebral infarction.
The data collected will (see Annex 2 CRF):
- Demographic data: age, sex, vascular risk factors, antithrombotic therapy at the entrance, history of Transient Ischemic Accident (TIA) or CI
- Data on the IC: arterial territory, side (right / left) or insular cortex reached severity (NIHSS score) made further examinations, echocardiography result, become during hospitalization (mRS)
- Monitoring Results scope ICU Neurovascular.
- Presence palpitations
- Treatment influencing the rate (beta-blockers or antiarrhythmic)
- Data on cardiac monitoring: time, duration, number of detected events
A questionnaire evaluating the safety of SpiderFlash® will be given to the patient (Appendix 3) and the results of Holter will be communicated at the end of the recording (as will be shown them in the Circular).
During a screening period of one month, 33 eligible patients over 65 admitted to CI 17 patients (51%) were identified including 9 with cryptogenic CI 8 and having either a non-significant atheroma is a rhythm disorder ( ESSV or atrial hyperexcitability). Among 16 ineligible patients, 4 had severe dementia, 11 had previous FA to 1 significant extracranial stenosis.
The patient recruitment period will be one year for one further year or two-year inclusion period to recruit 200 patients originally planned to study (the first year of inclusion has allowed us to include 73 patients) The data will be entered manually on paper CRF and Excel anonymized so not including the patient identifiers (name or IPP).
The originality of our study:
- Prospective study
- Inclusion of CI cryptogenic and non cryptogenic
- Laying SpiderFlash® early after CI
- Correlation with cardiac ultrasound parameters
- Analysis by the blind rhythm specialist (will not be aware of patient characteristics)
- Changing all events while recording (not just the passages FA)
- Questionnaire "comfort" given to the patient
Investigators specify that the data on the comfort of the patient questionnaire will not be transferred to the company Sorin; this questionnaire meets strict medical interest (including estimate the patient's ability to carry equipment during the full period).
Ethics / Regulatory:
The data processing will be carried out locally on the GHPSJ of anonymized way. The inclusion of patients will occur after patient information collection and its non-opposition traced in his medical records (Appendix 1). The data will be entered by the vascular neurologist anonymously. All patient information will remain confidential.
partnerships:
The Sorin company, manufacturer of SpiderFlash® provide (loan) material in sufficient quantity for the duration of the study.
The GHPSJ: neurologist time and CRA The SELARL rythmo: time heart rhythm specialists
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Uses of SpiderFlash monitor | Other | Device: Uses of SpiderFlash monitorThe intervention corresponds to the use of Spiderflash as Holter monitor. Investigators will use the SpiderFlash®, Holter monitor (technology "Secure Data") to have a storage capacity enabling a registration up to 30 days with sufficient autonomy. A questionnaire evaluating the safety of SpiderFlash® will be given to the patient and the results of Holter will be communicated at the end of the recording to the blinded rhythm specialist. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- ICU Neurovascular hospitalized for cerebral infarction CI
- No history of atrial fibrillation or flutter
- No hypercoagulable
- Patient unopposed and capable of carrying 21-day monitoring
Key exclusion criteria (8 listed)
- Patients with severe cognitive impairment that can not keep SpiderFlash® for 21 days
- Previous history of AF or flutter
- Significant artery stenosis requiring specific treatment (endarterectomy or stenting)
- FA on arrival at the ICU Neurovascular
- Trucks of a pacemaker or cardiac defibrillator
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 |
|---|---|---|
| Uses of SpiderFlash monitorInvestigators will use the SpiderFlash®, Holter monitor (technology "Secure Data") to have a storage capacity enabling a registration up to 30 days with sufficient autonomy. The data collected : * Demographic data: age, sex, vascular risk factors, antithrombotic therapy at the entrance, history of Transient Ischemic Accident (TIA) or Cerebral infarct (CI) * Data on the CI: * Monitoring Results scope ICU Neurovascular. * Presence palpitations * Treatment influencing the rate (beta-blockers or antiarrhythmic) * Data on cardiac monitoring: A questionnaire evaluating the safety of SpiderFlash® will be given to the patient and the results of Holter will be communicated at the end of the recording to the blinded rhythm specialist | Device | Uses of SpiderFlash monitor |
Primary outcome
Cardiac monitoring
Time frame: During the 30 days of monitoring
Data concerning cardiac monitoring: time, duration, number of detected events
2 secondary outcomes
NIHSS score
Time frame: Day 1
Treatment influencing the rate
Time frame: During the 30 days of monitoring
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 25 Apr 2019.
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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.
Mathieu ZUBER principal investigator
Groupe Hospitalier Paris Saint-Joseph (FRANCE)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uses of SpiderFlash monitor in people with Neuropathology, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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 4 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 25 Apr 2019. 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 France. 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 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?
Cardiac monitoring (time frame: During the 30 days of monitoring). 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 25 Apr 2019.