Monitoring Strategies for the Detection of Atrial Fibrillation in Patients with Cryptogenic Stroke

NCT04644679 | Terminated DMC FDA Device

• 1 other identifier: 5767
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation

  Detection of one episode of atrial fibrillation or atrial flutter \>30 seconds up to 7 days

  7 days

Secondary Outcomes (1)

• Supraventricular arrhythmia

  7 days

Study Arms (2)

48-hr

ACTIVE COMPARATOR

48-hr electrocardiographic monitoring

Diagnostic Test: 48-hr electrocardiographic monitoring

7-day

EXPERIMENTAL

7-day electrocardiographic monitoring

Diagnostic Test: 7-day electrocardiographic monitoring

Interventions

7-day electrocardiographic monitoring DIAGNOSTIC_TEST

7-day external electrocardiographic monitoring

7-day

48-hr electrocardiographic monitoring DIAGNOSTIC_TEST

48-hr external electrocardiographic monitoring

48-hr

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, C.a.b.a, C1199, Argentina

Location

MeSH Terms

Conditions

Stroke; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gustavo Maid, MD

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: November 25, 2020
• Study Start: November 2, 2020
• Primary Completion: September 30, 2021
• Study Completion: October 7, 2021
• Last Updated: November 21, 2024

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)