## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** 5767
#### Organization
**Class:** OTHER
**Full Name:** Hospital Italiano de Buenos Aires
### Status Module
#### Completion Date
**Date:** 2021-10-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-09-01

**Type:** ACTUAL

**Last Update Submit Date:** 2022-08-29

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2021-09-30

**Type:** ACTUAL

#### Start Date
**Date:** 2020-11-02

**Type:** ACTUAL

**Status Verified Date:** 2020-11

#### Study First Post Date
**Date:** 2020-11-25
**Type:** ACTUAL
**Study First Submit Date:** 2020-09-30
**Study First Submit QC Date:** 2020-11-19
**Why Stopped:** Poor enrollment rate
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hospital Italiano de Buenos Aires

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** True

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Stroke

- Atrial Fibrillation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 49

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 48-hr electrocardiographic monitoring

**Intervention Names:**

- Diagnostic Test: 48-hr electrocardiographic monitoring

**Label:** 48-hr

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** 7-day electrocardiographic monitoring

**Intervention Names:**

- Diagnostic Test: 7-day electrocardiographic monitoring

**Label:** 7-day

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 7-day

**Description:** 7-day external electrocardiographic monitoring

**Name:** 7-day electrocardiographic monitoring

**Type:** DIAGNOSTIC_TEST

#### Intervention 2

**Arm Group Labels:**

- 48-hr

**Description:** 48-hr external electrocardiographic monitoring

**Name:** 48-hr electrocardiographic monitoring

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Atrial fibrillation

**Time Frame:** 7 days

#### Secondary Outcomes

**Description:** Count of beats per day of non-sustained irregular atrial tachyarrhythmia or supraventricular extrasystoles up to 7 days

**Measure:** Supraventricular arrhythmia

**Time Frame:** 7 days

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Buenos Aires

**Country:** Argentina

**Facility:** Hospital Italiano de Buenos Aires

**State:** C.a.b.a

**Zip:** C1199

#### Overall Officials

**Official 1:**

**Affiliation:** Hospital Italiano de Buenos Aires

**Name:** Gustavo Maid, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002561

- Term: Cerebrovascular Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000001145

- Term: Arrhythmias, Cardiac

- ID: D000006331

- Term: Heart Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M22306

- Name: Stroke

- Relevance: HIGH

- As Found: Stroke

- ID: M4586

- Name: Atrial Fibrillation

- Relevance: HIGH

- As Found: Atrial Fibrillation

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M2400

- Name: Ischemic Stroke

- Relevance: HIGH

- As Found: Cryptogenic Stroke

- ID: M5810

- Name: Cerebrovascular Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4453

- Name: Arrhythmias, Cardiac

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000020521

- Term: Stroke

- ID: D000083242

- Term: Ischemic Stroke

- ID: D000001281

- Term: Atrial Fibrillation

### Misc Info Module

- Version Holder: 2024-05-24
