StrokeDIRECT-CTNCT07530588
Decentralized Imaging by REmote Computer Tomography for Cerebral Infarct Thrombolysis
A study testing Decentralized diagnostics and treatment in people with Stroke, run by University Hospital of North Norway at 2 sites in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Decentralized diagnostics and treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesNorway
- Study dates
- 17 Jul 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients presenting with a clinical suspected diagnosis of stroke more than 24 hours after symptom onset
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Eivor Logstein, MD contact
Norway2 sites, 2 recruiting
- Recruiting
Helgelandssykehuset Health Trust
Sandnessjøen
Eivor Logstein, MD, Eivor.Logstein@Helgelandssykehuset.no
Jon Våbenø, PhD, Jon.Vabeno@Helgelandssykehuset.no
- Recruiting
University Hospital of North Norway Health Trust
Tromsø
Agnethe Eltoft, MR, PhD, agnethe.eltoft@unn.no
Tor Ingebrigtsen, MD, PhD, Tor.Ingebrigtsen@unn.no
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Decentralized diagnostics and treatment
- Keywords
- Stroke, Rural, Prehospital diagnostics and treatment, Remote controlled computer tomography, Intravenous thrombolysis, District medical center
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decentralized diagnostics and treatmentOther
Also called Prehospital 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from EMC notification to initiation IVT treatment
The time from Emergency Medical Communication notification to initiation intravenous thrombolysis treatment in eligible patients
Measured: Day 0
Secondary outcomes (11)
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
Measured: 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
Measured: Day 0
Proportion of AIS patients receiving IVT treatment (y/n)
Proportion of acute ischaemic stroke patients receiving IVT treatment (y/n)
Measured: Day 0
Proportion of AIS patients receiving EVT treatment (y/n)
Proportion of acute ischaemic stroke patients receiving endovascular treatment
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Day 1
Time from symptom onset to groin puncture time
Time from symptom onset to groin puncture time in patients undergoing thrombectomy
Measured: Day 0
Transportation mode (ground or air ambulance)
Transportation mode to primary or comprehensive stroke centre
Measured: Day 0
Mortality
Mortality during hospitalization, 30 days, 90 days and 1 year
Measured: Year 1
Final diagnosis
The final discharge diagnosis
Measured: Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start17 Jul 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Helgelandssykehuset Hospital Trust, Nordlandssykehuset Hospital Trust, Finnmarkssykehuset HF, UiT The Arctic University of Norway, Innlandet Central Hospital HF, Lillehammer, Oslo University Hospital, Ringerike hospital HF, Hønefoss Norway
- Responsible party
- Sponsor
- Investigators
- Tor Ingebrigtsen, MD, PhD, Study director, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530588
- Sponsor's protocol ID
- 2025/902936 (REK)
- Other IDs
- 2025
- Acronym
- DIRECT-CT
- Status last verified
- Jul 2025
- First submitted
- 18 Jul 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Controlled CT Scanning for Decentralized Diagnostics and Treatment Versus Standard Care in Acute Stroke
- ClinicalTrials.gov ID
- NCT07530588
- Acronym / sponsor ID
- DIRECT-CT / 2025/902936 (REK)
- Conditions
- Stroke
- Keywords
- Stroke, Rural, Prehospital diagnostics and treatment, Remote controlled computer tomography, Intravenous thrombolysis, District medical center
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- Helgelandssykehuset Hospital Trust, Nordlandssykehuset Hospital Trust, Finnmarkssykehuset HF, UiT The Arctic University of Norway, Innlandet Central Hospital HF, Lillehammer, Oslo University Hospital, Ringerike hospital HF, Hønefoss Norway
- Study start
- 17 Jul 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Decentralized diagnostics and treatmentParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patients presenting with a clinical suspected diagnosis of stroke more than 24 hours after symptom onset
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decentralized diagnostics and treatmentAlso: Prehospital diagnostics and treatmentThe 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 | Intervention arm |
Primary outcome
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
11 secondary outcomes
Time from admittance to initiation of IVT treatment (door-to-needle time)
Time frame: Day 0
Time from admittance to start of blood pressure lowering medication in ICH patients
Time frame: Day 0
Proportion of AIS patients receiving IVT treatment (y/n)
Time frame: Day 0
Proportion of AIS patients receiving EVT treatment (y/n)
Time frame: Day 0
Proportion of patients achieving early neurological improvement
Time frame: Day 1
mRS score at 90 days
Time frame: Month 3
Proportion of patients with symptomatic intracranial hemorrhage (sICH)
Time frame: Day 1
Time from symptom onset to groin puncture time
Time frame: Day 0
Transportation mode (ground or air ambulance)
Time frame: Day 0
Mortality
Time frame: Year 1
Final diagnosis
Time frame: Week 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eivor Logstein, MD contact
Tor Ingebrigtsen, MD, PhD study director
University Hospital of North Norway
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decentralized diagnostics and treatment in people with Stroke, run by University Hospital of North Norway at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Agnethe Eltoft, MD, PhD (+4797193417, agnethe.eltoft@unn.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from EMC notification to initiation IVT treatment (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.