Decentralized Imaging by REmote Computer Tomography for Cerebral Infarct Thrombolysis (DIRECT-CT)

Remote Controlled CT Scanning for Decentralized Diagnostics and Treatment Versus Standard Care in Acute Stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Decentralized diagnostics and treatment

Detailed Description

Intravenous thrombolysis (IVT) treatment is an effective treatment of disabling acute ischemic stroke (AIS) and leads to improved functional outcomes if administered within 4.5 hours after symptom onset. Since the treatment effect is highly time dependent, it is recommended to give IVT as soon as possible after symptom onset to patients with AIS without contraindications. A CT examination of the head must be performed prior to IVT to exclude intracranial hemorrhage. If an intracerebral hemorrhage (ICH) is detected rapid blood pressure lowering medication should be initiated. As of today, timely delivery of acute stroke treatment is challenging in several parts of Norway due to sparsely populated areas with long geographical distances between hospitals. Patients living in rural areas are at risk of not receiving timely acute stroke treatment. Due to the time sensitive nature of IVT, a decentralized approach to diagnostics and treatment is compelling. However, a CT scanner and medical expertise on acute stroke diagnostics and treatment is not readily available in pre-hospital settings in Norway. Investigators therefore plan to 1) assess the feasibility of widespread implementation of a model with decentralized stroke diagnostics and treatment in rural areas with a stationary CT combined with audio-and video guided support from an experienced stroke team at the local hospital 2) compare treatment access, time metrics and outcomes for stroke patients in the DMC catchment area to patients from similar rural areas without access to decentralized diagnostics and treatment. The risk for patients is minimized through remote controlled CT scanning administered from the local hospital combined with tele-stroke guided assessment by an experienced stroke team and regular simulation trainings. All treatment, including thrombolytic therapy, and monitoring routines are performed according to the hospitals' standard operating procedures (SOP). The primary objective is to compare time from Emergency Medical Communication (EMC) notification to IVT treatment between AIS patients in the intervention group comprising patients from geographical areas with an established service of prehospital stroke diagnostics and treatment at the DMC to the control group comprising patients from similar geographical areas undergoing diagnostics and treatment at their local hospital as per standard pathway.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Agnethe Eltoft, MD, PhD; Phone Number: +4797193417; Email: agnethe.eltoft@unn.no
• Study Contact Backup: Name: Eivor Logstein, MD; Email: Eivor.Logstein@Helgelandssykehuset.no

Study Locations

• Norway
  • Sandnessjøen, Norway
    • Recruiting
    • Helgelandssykehuset Health Trust
    • Contact: Eivor Logstein, MD; Email: Eivor.Logstein@Helgelandssykehuset.no
    • Contact: Jon Våbenø, PhD; Email: Jon.Vabeno@Helgelandssykehuset.no
  • Tromsø, Norway
    • Recruiting
    • University Hospital of North Norway Health Trust
    • Contact: Agnethe Eltoft, MR, PhD; Email: agnethe.eltoft@unn.no
    • Contact: Tor Ingebrigtsen, MD, PhD; Email: Tor.Ingebrigtsen@unn.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; 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; 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.; Other Names: Prehospital diagnostics and treatment
No Intervention: Control; 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.
No Intervention: Historical control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from admittance to initiation of IVT treatment (door-to-needle time)	Time from admittance to initiation of IVT treatment (door-to-needle time) in eligible patients	Day 0
Time from admittance to start of blood pressure lowering medication in ICH patients	Time from admittance to start of blood pressure lowering medication in ICH patients patients	Day 0
Proportion of AIS patients receiving IVT treatment (y/n)	Proportion of acute ischaemic stroke patients receiving IVT treatment (y/n)	Day 0
Proportion of AIS patients receiving EVT treatment (y/n)	Proportion of acute ischaemic stroke patients receiving endovascular treatment	Day 0
Proportion of patients achieving early neurological improvement	Early neurological improvement, defined as a reduction of ≥8 points on the NHISS, or NIHSS score of 0-1 at 24 hours (22-36 h) (y/n)	Day 1
mRS score at 90 days	functional outcome measured by the modified Rankin Scale score (mRS) at discharge and day 90 (± 2 weeks) • mRS category at day 90 (+/- 2 weeks); excellent functional outcome (mRS 0-1) at day 90 (+/- 2 weeks); good functional outcome (mRS 0-2) at day 90 (+/- 2weeks); poor functional outcome (mRS 5-6) at day 90 (+/- 2 weeks)	Month 3
Proportion of patients with symptomatic intracranial hemorrhage (sICH)	Proportion of patients with symptomatic intracranial hemorrhage (sICH) complications defined as intracranial hemorrhage on CT/MRI within 36 hours post IVT causally related to an increase of 4 points or more on the NIHSS (y/n)	Day 1
Time from symptom onset to groin puncture time	Time from symptom onset to groin puncture time in patients undergoing thrombectomy	Day 0
Transportation mode (ground or air ambulance)	Transportation mode to primary or comprehensive stroke centre	Day 0
Mortality	Mortality during hospitalization, 30 days, 90 days and 1 year	Year 1
Final diagnosis	The final discharge diagnosis	Week 2

Collaborators and Investigators

• Sponsor: University Hospital of North Norway
• Collaborators: Oslo University Hospital; Helgelandssykehuset Hospital Trust; Nordlandssykehuset Hospital Trust; UiT The Arctic University of Norway; Ringerike hospital HF, Hønefoss Norway; Finnmarkssykehuset HF; Innlandet Central Hospital HF, Lillehammer
• Investigators: Study Director: Tor Ingebrigtsen, MD, PhD, University Hospital of North Norway

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: July 18, 2025
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Stroke; Rural; Intravenous thrombolysis; Prehospital diagnostics and treatment; Remote controlled computer tomography; District medical center
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Therapeutics
• Other Study ID Numbers: 2025/902936 (REK)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No