Microembolic Detection in Acute Ischemic Stroke Patients... | NCT06018090

Studies
Microembolic Detection in Acute Ischemic Stroke Patients With Atrial Fibrillation and Outcome

NCT06018090

Sponsor

Centro Hospitalar De São João, E.P.E.

Status

Completed

Last Update Posted

Aug 30, 2023Actual

Enrollment

61Actual

Phase

Not provided

Conditions

Infarction, Brain
Embolism
Atrial Fibrillation

Interventions

The presence and rate of MES measured by TCD monitoring

Countries

Portugal

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 6, 2019Actual

Primary Completion Date

Aug 31, 2022Actual

Completion Date

Oct 6, 2022Actual

First Submitted Date

Aug 25, 2023

First Submission Date that Met QC Criteria

Aug 25, 2023

First Posted Date

Aug 30, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2023

Last Update Posted Date

Aug 30, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pedro Castro, Professor, Centro Hospitalar De São João, E.P.E.Principal Investigator

Lead Sponsor

Centro Hospitalar De São João, E.P.E.OTHER

Collaborators

Name	Class
University of Giessen	OTHER
University of Padova	OTHER
University of Ostrava	OTHER
Clinical Hospital Centre Zagreb

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This multicenter international prospective cohort study will include patients with AIS with a known or newly diagnosed anticoagulant-naïve AF. All centers will use the same transcranial Doppler machine for one-hour monitoring with bilateral 2-MHz probes within 24 hours of symptom onset. Recordings will be analyzed for MES by a blinded central reader. The primary aim is to determine the proportion of patients with MES and the association of MES with functional outcomes assessed by a modified Rankin scale (mRS) score at 90 days.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

90 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acute Ischemic Stroke Patients with Atrial Fibrillation			Other: The presence and rate of MES measured by TCD monitoring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
The presence and rate of MES measured by TCD monitoring	Other	TCD monitoring within 24 hours from the last known well time. Bilateral M1 segments of middle cerebral artery were insonated at a single depth with 2-MHz transducers secured by a probe-holder.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of MES		Within 24 hours of symptom onset
Poor functional outcome		90-days after stroke

Secondary Outcomes

Measure	Description	Time Frame
Ordinal Shift Analysis of mRS scale score		90-days after stroke

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

acute ischemic stroke admitted to the Stroke Unit, history of AF/flutter or a new diagnosis of AF at the stroke, and with a possibility to be monitored within 24 hours after symptom onset.

Exclusion Criteria:

use of anticoagulants at stroke onset; prosthetic valves; inadequate temporal bone window; uncooperative patients.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Acute ischemic stroke admitted to the Stroke Unit, history of AF/flutter, or a new diagnosis of AF at the time of stroke, and able possibility to be monitored within 24 hours after symptom onset.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pedro Miguel Castro		Porto		4200-319	Portugal

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38149620	Derived	Castro P, Ferreira J, Malojcic B, Bazadona D, Baracchini C, Pieroni A, Skoloudik D, Azevedo E, Kaps M. Detection of microemboli in patients with acute ischaemic stroke and atrial fibrillation suggests poor functional outcome. Eur Stroke J. 2024 Jun;9(2):409-417. doi: 10.1177/23969873231220508. Epub 2023 Dec 27.

ID	Term
D020520	Brain Infarction
D004617	Embolism
D001281	Atrial Fibrillation
D007238	Infarction

ID	Term
D002545	Brain Ischemia
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases