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

NCT02778321 | Completed DMC

• 1 other identifier: SPIDERFLASH
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathology

Outcome Measures

Primary Outcomes (1)

• Cardiac monitoring

  Data concerning cardiac monitoring: time, duration, number of detected events

  During the 30 days of monitoring

Secondary Outcomes (2)

• NIHSS score

  Day 1

• Treatment influencing the rate

  During the 30 days of monitoring

Study Arms (1)

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.

Device: Uses of SpiderFlash monitor

Interventions

Uses of SpiderFlash monitor DEVICE

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

Uses of SpiderFlash monitor

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Study Officials

• Mathieu ZUBER

  Groupe Hospitalier Paris Saint-Joseph (FRANCE)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 19, 2016
• Study Start: November 17, 2014
• Primary Completion: July 31, 2018
• Study Completion: April 24, 2019
• Last Updated: April 25, 2019

Record last verified: 2019-04

Locations

FR (1)