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NCT Number: NCT07530588

Decentralized Imaging by REmote Computer Tomography for Cerebral Infarct Thrombolysis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helgelandssykehuset Health Trust, Sandnessjøen, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Prehospital diagnostics and treatment

Primary outcomes

  1. Time from EMC notification to initiation IVT treatment

    Time frame: Day 0

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

Secondary outcomes

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

    Time frame: Day 0

    Time from admittance to initiation of IVT treatment (door-to-needle time) in eligible patients

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

    Time frame: Day 0

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

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

    Time frame: Day 0

    Proportion of acute ischaemic stroke patients receiving IVT treatment (y/n)

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

    Time frame: Day 0

    Proportion of acute ischaemic stroke patients receiving endovascular treatment

  5. Proportion of patients achieving early neurological improvement

    Time frame: Day 1

    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)

  6. mRS score at 90 days

    Time frame: Month 3

    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)
  7. Proportion of patients with symptomatic intracranial hemorrhage (sICH)

    Time frame: Day 1

    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)

  8. Time from symptom onset to groin puncture time

    Time frame: Day 0

    Time from symptom onset to groin puncture time in patients undergoing thrombectomy

  9. Transportation mode (ground or air ambulance)

    Time frame: Day 0

    Transportation mode to primary or comprehensive stroke centre

  10. Mortality

    Time frame: Year 1

    Mortality during hospitalization, 30 days, 90 days and 1 year

  11. Final diagnosis

    Time frame: Week 2

    The final discharge diagnosis

Study contacts

Contact information is provided by the study sponsor or research team.

Agnethe Eltoft, MD, PhD

CONTACT

[email protected]

+4797193417

Eivor Logstein, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Collaborators

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

Registry information

Official study title

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

Acronym: DIRECT-CT

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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