Decentralized Imaging by REmote Computer Tomography for Cerebral Infarct Thrombolysis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Decentralized diagnostics and treatment.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Remote Controlled CT Scanning for Decentralized Diagnostics and Treatment Versus Standard Care in Acute Stroke
Overview
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.
Interventions
- 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
Primary outcome measures
- Time from EMC notification to initiation IVT treatment [Time frame: Day 0]
Secondary outcome measures (11)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Norway · 2 centers
- Helgelandssykehuset Health Trust — Sandnessjøen
- University Hospital of North Norway Health Trust — Tromsø
Identifiers
NCT: NCT07530588 · 2025/902936 (REK)