Back to resultsMonitoring Strategies for the Detection of Atrial Fibrillation in Patients With Cryptogenic Stroke
Primary Purpose
Stroke, Atrial Fibrillation
Status
Terminated
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
7-day electrocardiographic monitoring
48-hr electrocardiographic monitoring
Sponsored by
About this trial
This is an interventional diagnostic trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- All patients who have studies that classify stroke or TIA as cryptogenic and who can carry out monitoring for 48 hours or 7 days will be included.
- Age ≥ 18 years
Exclusion criteria
- History of atrial fibrillation (or atrial flutter) documented.
- Patients who already have an event recorder in place, permanent pacemaker, or implantable cardioverter-defibrillator
- Evidence of lacunar infarction.
- Hemorrhagic stroke
- Patient for palliative care
Sites / Locations
- Hospital Italiano de Buenos Aires
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
48-hr
7-day
Arm Description
48-hr electrocardiographic monitoring
7-day electrocardiographic monitoring
Outcomes
Primary Outcome Measures
Atrial fibrillation
Detection of one episode of atrial fibrillation or atrial flutter >30 seconds up to 7 days
Secondary Outcome Measures
Supraventricular arrhythmia
Count of beats per day of non-sustained irregular atrial tachyarrhythmia or supraventricular extrasystoles up to 7 days
Full Information
NCT ID
NCT04644679
First Posted
September 30, 2020
Last Updated
August 29, 2022
Sponsor
Hospital Italiano de Buenos Aires
1. Study Identification
Unique Protocol Identification Number
NCT04644679
Brief Title
Monitoring Strategies for the Detection of Atrial Fibrillation in Patients With Cryptogenic Stroke
Official Title
48-hour Versus 7-day Monitoring for the Detection of Atrial Fibrillation in Patients With Cryptogenic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment rate
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
October 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Italiano de Buenos Aires
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Randomized clinical trial comparing two monitoring strategies, the use of a 48-hour Holter (routine care branch) and an event recorder for 7 days (intervention branch).
Patients admitted for cryptogenic stroke will be included. Enrollment and randomization of patients will be carried out during the index case hospitalization, while follow-up will be done on an outpatient basis until day 7.
Detailed Description
Once the diagnose of cryptogenic stroke have been carried out, informed consent will be taken and participants will be randomized to 48-hour monitoring arm or 7-day monitoring arm, followed by discharge from hospital.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Atrial Fibrillation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
48-hr
Arm Type
Active Comparator
Arm Description
48-hr electrocardiographic monitoring
Arm Title
7-day
Arm Type
Experimental
Arm Description
7-day electrocardiographic monitoring
Intervention Type
Diagnostic Test
Intervention Name(s)
7-day electrocardiographic monitoring
Intervention Description
7-day external electrocardiographic monitoring
Intervention Type
Diagnostic Test
Intervention Name(s)
48-hr electrocardiographic monitoring
Intervention Description
48-hr external electrocardiographic monitoring
Primary Outcome Measure Information:
Title
Atrial fibrillation
Description
Detection of one episode of atrial fibrillation or atrial flutter >30 seconds up to 7 days
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Supraventricular arrhythmia
Description
Count of beats per day of non-sustained irregular atrial tachyarrhythmia or supraventricular extrasystoles up to 7 days
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients who have studies that classify stroke or TIA as cryptogenic and who can carry out monitoring for 48 hours or 7 days will be included.
Age ≥ 18 years
Exclusion criteria
History of atrial fibrillation (or atrial flutter) documented.
Patients who already have an event recorder in place, permanent pacemaker, or implantable cardioverter-defibrillator
Evidence of lacunar infarction.
Hemorrhagic stroke
Patient for palliative care
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustavo Maid, MD
Organizational Affiliation
Hospital Italiano de Buenos Aires
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
State/Province
C.a.b.a
ZIP/Postal Code
C1199
Country
Argentina
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Monitoring Strategies for the Detection of Atrial Fibrillation in Patients With Cryptogenic Stroke
We'll reach out to this number within 24 hrs