Decentralized Imaging by REmote Computer Tomography for Cerebral Infarct Thrombolysis

NCT07530588 | Recruiting

• 1 other identifier: 2025/902936 (REK)
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

The DIRECT-CT trial is designed to test the hypothesis that remote controlled CT scanning combined with real time audio-and video conference (AVC) guided assessment from an experienced hospital stroke team (tele-stroke) at decentralized medical centers (DMC) reduces time to intravenous thrombolytic treatment compared to the standard pathway.

Conditions

Stroke

Keywords

Stroke; Rural; Prehospital diagnostics and treatment; Remote controlled computer tomography; Intravenous thrombolysis; District medical center

Outcome Measures

Primary Outcomes (1)

• Time from EMC notification to initiation IVT treatment

  The time from Emergency Medical Communication notification to initiation intravenous thrombolysis treatment in eligible patients

  Day 0

Secondary Outcomes (11)

• Time from admittance to initiation of IVT treatment (door-to-needle time)

  Day 0

• Time from admittance to start of blood pressure lowering medication in ICH patients

  Day 0

• Proportion of AIS patients receiving IVT treatment (y/n)

  Day 0

• Proportion of AIS patients receiving EVT treatment (y/n)

  Day 0

• Proportion of patients achieving early neurological improvement

  Day 1

Study Arms (3)

Intervention arm

EXPERIMENTAL

Participants are patients presenting with acute stroke symptoms in rural districts in Norway. A cockpit solution by Syngo Virtual Cockpit® software for remote control of the stationary CT machine at the DMCs from the nearest stroke center is implemented. The EMC center routes the ambulance to DMC Midt-Troms when it is the nearest. A nurse at DMC and the ambulance personnel performs the clinical examination and positions the patient in the CT machine. Through AVC the examination is overseen by the stroke physician, images are interpreted by a radiologist at UNN, and the decision regarding acute treatment is made by the stroke physician at UNN, Tromsø. If indicated, IVT and blood pressure lowering medication is administered by the nurse at the DMC. Patients resenting with acute stroke symptoms in the catchment area of DMC Midt-Troms (Sørreisa and Senja municipalities) and DMC Sør-Helgeland (Brønnøy and Sømna municipalities) comprise the intervention group.

Other: Decentralized diagnostics and treatment

Control

NO INTERVENTION

1\) Patients presenting with acute stroke symptoms residing in municipalities in Nord-Troms (Nordreisa, Kåfjord, Skjervøy and Kvænangen) and Nordland (Saltdal, Hamarøy, Steigen and Sørfold) from the time of DMC model implementation until end of study. These patients are from areas that are geographically similar to Midt-Troms and Sør-Helgeland with regards to distance to the nearest hospital, but without access to prehospital CT diagnostics and acute stroke treatment.

Historical control

NO INTERVENTION

This control group consists of acute stroke patients from the same municipalities (both intervention and control group) presenting with stroke symptoms within a 5 year period prior to the implementation of prehospital diagnostics and treatment at the DMC.

Interventions

Decentralized diagnostics and treatment OTHER

The intervention includes admittance to the DMC for initial diagnostic work up and acute treatment (if indicated). Paramedics examine the patient and assess stroke severity by NIHSS and G-FAST scoring overseen by a stroke physician at the local hospital through real time video conference. A remote controlled CT scan of the head is conducted, and the stroke team at the local hospital evaluates results and makes a treatment decision in real-time AVC. If treatment is indicated, this is administered by local personnel at the DMC before initiating transport to the local hospital or the comprehensive stroke center in case of LVO. Patients who are unable to reach the DMC prior to estimated admission time at their local hospital, will be treated at their local hospital as per standard pathway.

Also known as: Prehospital diagnostics and treatment

Intervention arm

Eligibility Criteria

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

You may qualify if:

• \- Patients in the catchments areas of the intervention and control group presenting with a clinical suspected diagnosis of stroke within symptom onset within the last 24 hours

You may not qualify if:

• \- Patients presenting with a clinical suspected diagnosis of stroke more than 24 hours after symptom onset

Sponsors & Collaborators

• University Hospital of North Norway: lead
• Helgelandssykehuset Hospital Trust: collaborator
• Finnmarkssykehuset HF: collaborator
• UiT The Arctic University of Norway: collaborator
• Innlandet Central Hospital HF, Lillehammer: collaborator
• Oslo University Hospital: collaborator
• Ringerike hospital HF, Hønefoss Norway: collaborator
• Nordlandssykehuset Hospital Trust: collaborator

Study Sites (2)

Helgelandssykehuset Health Trust

Sandnessjøen, Norway

RECRUITING

University Hospital of North Norway Health Trust

Tromsø, Norway

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tor Ingebrigtsen, MD, PhD

  University Hospital of North Norway

  STUDY DIRECTOR

Central Study Contacts

Agnethe Eltoft, MD, PhD

CONTACT

+4797193417; agnethe.eltoft@unn.no

Eivor Logstein, MD

CONTACT

Eivor.Logstein@Helgelandssykehuset.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective open label, parallel group controlled observational clinical study investigating the effect of a health service innovation. The study assesses the superiority of a model with prehospital remote controlled CT scanning combined with telestroke guided assessment for decentralized diagnostics and acute stroke treatment at the DMCs compared to the standard pathway for stroke patients in rural Norway.

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: April 15, 2026
• Study Start: July 17, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 15, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)