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Trial record 2 of 4 for:    crystal af

Prospective Study Evaluating the Interest of Long-term Cardiac Recording in Cerebral Infarction (SPIDERFLASH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02778321
Recruitment Status : Completed
First Posted : May 19, 2016
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Neuropathology Device: Uses of SpiderFlash monitor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Prospective Study Evaluating the Interest of Long-term Cardiac Recording in Cerebral Infarction
Actual Study Start Date : November 17, 2014
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : April 24, 2019

Arm Intervention/treatment
Uses of SpiderFlash monitor

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.

Device: Uses of SpiderFlash 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.

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





Primary Outcome Measures :
  1. Cardiac monitoring [ Time Frame: During the 30 days of monitoring ]
    Data concerning cardiac monitoring: time, duration, number of detected events


Secondary Outcome Measures :
  1. NIHSS score [ Time Frame: Day 1 ]
    Diagnostic and stroke severity score measures the intensity of neurological signs to monitor their progress and estimate their severity.

  2. Treatment influencing the rate [ Time Frame: During the 30 days of monitoring ]
    Treatment influencing the rate (beta blockers or antiarrhythmic drugs)



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

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 CI more than 10 days
  • Other sources of cardiac embolism
  • Pejorative prognosis (mRS≥5)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02778321


Locations
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France
Groupe Hospitalier Paris Saint Joseph
Paris, Ile-de-France, France, 75014
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
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Principal Investigator: Mathieu ZUBER Groupe Hospitalier Paris Saint-Joseph (FRANCE)
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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT02778321    
Other Study ID Numbers: SPIDERFLASH
First Posted: May 19, 2016    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Cerebral Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases