## Protocol Section
### Identification Module
**NCT ID:** NCT06427746

**Acronym:** AIPO

**Brief Title:** Enhancing Prehospital Stroke Diagnosis

**Official Title:** Accuracy and Implementation of Diagnostic Ability in Stroke in the Pre-Hospital Setting

#### Organization Study ID Info
**ID:** AREU_A.I.P.O.
#### Organization
**Class:** OTHER_GOV
**Full Name:** Agenzia Regionale emergenza Urgenza
### Status Module
#### Completion Date
**Date:** 2024-08-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-11-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Agenzia Regionale emergenza Urgenza

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** Current American Heart Association Guidelines recommend that stroke patients be promptly rescued and identified so that the accepting hospital can be alerted and prepared to receive and treat them promptly. It is also recommend that stroke identification be performed using validated and standardized assessment scales. This study aims to analyze the possibility to increase the correct identification of stroke patients after implementation of several new operative procedures by the emergency medical service (EMS) of the metropolitan area of Milan (SOREU). The interventions adopted include:

1. the evaluation of patients with suspected stroke via video call between the lay rescue personnel and the dispatch healthcare personnel
2. the training of lay rescue personnel, operating in the metropolitan area, aimed at implementing the application of the Cincinnati Prehospital Stroke Scale (CPSS) scale and to expand the neurological examination with the addiction of the Large ARtery Intracranial Occlusion Stroke Scale (LARIO) in the clinical evaluation.

### Conditions Module

**Conditions:**

- Stroke

**Keywords:**

- stroke

- video call

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 2197

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** stroke diagnosis in the pre-hospital settings, based on the CPSS scale assessed by lay rescuers

**Intervention Names:**

- Procedure: Standard

**Label:** Standard

#### Arm Group 2

**Description:** stroke diagnosis in the pre-hospital settings, based on the CPSS scale assessed by lay rescuers during live video call with the healthcare personnel in EMS dispatch

**Intervention Names:**

- Procedure: Video call

**Label:** Video call

#### Arm Group 3

**Description:** stroke diagnosis in the pre-hospital settings, based on the CPSS + LARIO scales assessed by lay rescuers (with specific training on the 2 scales) during live video call with the healthcare personnel in EMS dispatch

**Intervention Names:**

- Procedure: Video call + LARIO

**Label:** Video call + LARIO

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Standard

**Description:** Basic ambulance personnel are trained in the application of the CPSS scale in suspected stroke. The CPSS scale is a tool used to quickly assess stroke severity in pre-hospital settings. It is a three-point scale that takes into account the patient's level of consciousness, facial droop, and arm weakness. If a patient with suspected stroke meets certain criteria, they will be coded as having a suspected stroke by the SOREU. These criteria include having one item in three of the CPSS scale, being of adult age, and being independent at home.

**Name:** Standard

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Video call

**Description:** Among the tools already available to improve evaluation of patients rescued in the field, SOREU has video calls between the dispatch room physician and the rescuer in the field. Thus, the rescuer in the field will perform the CPSS during ongoing video call with the dispatch room, allowing the remote evaluation of the patient by the healthcare worker present in the control room, potentially increasing the ability to identify a stroke.

**Name:** Video call

**Type:** PROCEDURE

#### Intervention 3

**Arm Group Labels:**

- Video call + LARIO

**Description:** LARIO scale's effectiveness in identifying patients with ischemic stroke caused by a large vessel occlusion in the anterior cerebral circulation. The anterior cerebral circulation supplies blood to the front and upper parts of the brain. Occlusion of a large vessel in this area can lead to a severe stroke. Rescuer in the field will perform the CPSS and the LARIO during ongoing video call with the dispatch room, allowing the remote evaluation of the patient by the healthcare worker present in the control room.

**Name:** Video call + LARIO

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Evaluate if the use of the video call with or without the assessment of the LARIO scale, between the prehospital lay rescuer and the medical dispatch improve the identification of stroke patients in comparison to the only CPSS scale evaluated by the lay rescuer. The diagnosis accuracy is evaluated by confirmation of stroke at the cerebral angio-CT scan

**Measure:** Accuracy of prehospital stroke diagnosis

**Time Frame:** within 2 hours from hospital admission

#### Secondary Outcomes

**Description:** LARIO is a stroke scale is a simple 5-item clinical scale that can be used to predict the presence of large vessel occlusion (LVO) in patients with acute ischemic stroke. A large vessel of the anterior cerebral circulation is defined as occlusion of the intracranial segment of the internal carotid artery, anterior cerebral artery segments A1 and A2, and middle cerebral artery segments M1 and M2. Final diagnosis is based on the cerebral angio CT scan

**Measure:** Accuracy of the Large ARtery Intracranial Occlusion (LARIO) scale to identify a stroke with occlusion of a large vessels

**Time Frame:** within 2 hours from hospital admission

**Description:** incidence of hemorrhagic stroke among patients identified as stroke patients. Diagnosis is based on the results of the cerebral CT

**Measure:** incidence of hemorrhagic stroke

**Time Frame:** within 2 hours hospital admission

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* suspected stroke
* rescued by basic life support vehicle
* consciousness
* informed consent

Exclusion Criteria:

* age \< 18 years
* rescued by an advanced life support vehicle

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Adult patients in the prehospital setting with suspected ischemic stroke rescued by the emergency medical service in the Milan metropolitan area

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** a.coppo@areu.lombardia.it

**Name:** Anna Coppo, MD

**Phone:** 0267129001

**Role:** CONTACT

**Contact 2:**

**Email:** gristag@gmail.com

**Name:** Giuseppe Ristagno, MD, PhD

**Phone:** 0267129001

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Milan

**Contacts:**

***Contact 1:***

- **Email:** p.manzoni@areu.lombardia.it

- **Name:** Paola Manzoni, MD

- **Phone:** 02 52872802

- **Role:** CONTACT

***Contact 2:***

- **Name:** Michela Generali, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Italy

**Facility:** SOREU Metropolitana

**Status:** RECRUITING

**Zip:** 20100

#### Overall Officials

**Official 1:**

**Affiliation:** AREU

**Name:** Anna Coppo, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## 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

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M22306

- Name: Stroke

- Relevance: HIGH

- As Found: 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

### Condition Browse Module - Meshes

- ID: D000020521

- Term: Stroke

### Misc Info Module

- Version Holder: 2024-05-31
