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

NCT02778321 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2019-04-25

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Fondation Hôpital Saint-Joseph

    lead OTHER

Principal Investigators

  • Mathieu ZUBER · Groupe Hospitalier Paris Saint-Joseph (FRANCE)

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-17
Primary Completion
2018-07-31
Completion
2019-04-24

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02778321 on ClinicalTrials.gov