StrokeRURALCTNCT03577847
Rural CT Examination and Thrombolytic Treatment for Stroke
An observational study of Stroke, run by Vestre Viken Hospital Trust at 1 site in Norway.
Trial summary
To counteract long term sequelae from stroke, ultrarapid diagnosis and treatment, high quality multidiciplinary in-hospital care and optimal long term rehabilitation is required. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Rural CT scanning
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- 20 Nov 2017to 31 Dec 2021
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Intervention group (access to local CT): Patients from the municipalities Hol, Ål, Gol, Hemsedal and Nes. Control group (no local CT): Patients from the municipalities Nore and Uvdal, Vang, Øystre- and Vestre Slidre, Lesja, Skjåk, Lom, Dovre, Vågå and Sel.
Who may be able to join
- Patients over 18 years being investigated by CT within 24 hours for acute symptoms of stroke.
- Fullfilling criteria for the diagnosis acute stroke as described by the Norwegian stroke registry.
- Giving informed consent.
Who cannot join
- Symptoms not due to ischaemic or haemorrhagic stroke as adjudicated at discharge.
- Not able to cooperate to 3 months follow up.
- Not giving informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rural CT Examination and Thrombolytic Treatment for Stroke: An Observational Study of Medical and Health Economic Effects
To counteract long term sequelae from stroke, ultrarapid diagnosis and treatment, high quality multidiciplinary in-hospital care and optimal long term rehabilitation is required. In this study, the investigators are moving the essential first diagnosis and treatment out into the community close to where the patient live, thus shortening the all important time from debut of symptoms to thrombolytic treatment improving the prognosis of stroke patients.
Read the detailed description
Stroke is an acute, potentially mutilating disease. To counteract long term sequelae three factors are essential: Ultrarapid diagnosis and treatment, high quality multidiciplinary in-hospital care and optimal long term rehabilitation. Initial diagnosis and treatment has up to now been completed within the hospital domain. This study will change that: moving the essential first diagnosis and treatment out into the community close to where the patient lives thus shortening the all important time from debut of symptoms to thrombolytic treatment. We will operate a local computer tomography (CT) service in the hands of community based non-specialized health care personnel (MD and nurse) acting under direct telemetric guidance from on call hospital specialists. Thus, the investigators will show that by combining current technological advances in real time video communication with an acutely well functioning cooperation between the community and hospital health service personnel the prognosis of stroke patients is improved.
- Conditions
- Stroke
- Being tested
- Rural CT scanning
- Keywords
- Stroke, Thrombolysis, Rural CT
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rural CT scanningDiagnostic test
Also called Thrombolysis
Rural computer tomography for acute stroke
| Study group | Role | What they receive |
|---|---|---|
| 1 | Intervention group: Stroke patients investigated with rural CT scanning at HSS, Ål. Patients living in the municipalities of Hol, Ål, Gol, Hemsedal and Nes. Receives: Diagnostic Test: Rural CT scanning | |
| 2 | Control-group: Stroke patients with similar transportation time to hospital, but no access to rural CT scanning. Patients living in the municipalities of Nore- and Uvdal, Vang, Øystre and Vestre Slidre, Lesja, Vågå, Lom, Dovre, Skjåk and Sel. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombolytic treatment
The proportion of patients with ischaemic stroke receiving thrombolytic treatment in percent.
Measured: 3 months
Secondary outcomes (4)
Ictus to needle time
Time from onset of stroke symptoms (Ictus) to thrombolytic treatment (Needle).
Measured: 3 months
Functional status
Modified Rankin Scale (mRS score 0-6). Good outcome 0-2
Measured: 3 months
Cognitive status
Montreal Cognitive Assessment (MoCA score 0-30). Good outcome 26-30
Measured: 3 months
Depression
Geriatric depression scale (GDS score 0-30). Good outcome 0-10
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start20 Nov 2017
- Primary completion7 Apr 2020
- Study completion31 Dec 2021 (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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Extrastiftelsen
- Responsible party
- Sponsor
- Investigators
- Jorgen M Ibsen, MD, Principal investigator, Vestre Viken Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577847
- Sponsor's protocol ID
- REK 2017/102
- Acronym
- RURALCT
- Status last verified
- Apr 2021
- First submitted
- 9 Jan 2018
- Last updated
- 14 Apr 2021
- 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 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rural CT Examination and Thrombolytic Treatment for Stroke: An Observational Study of Medical and Health Economic Effects
- ClinicalTrials.gov ID
- NCT03577847
- Acronym / sponsor ID
- RURALCT / REK 2017/102
- Conditions
- Stroke
- Keywords
- Stroke, Thrombolysis, Rural CT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Collaborators
- Extrastiftelsen
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 7 Apr 2020 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 5 Jul 2018 (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.
To counteract long term sequelae from stroke, ultrarapid diagnosis and treatment, high quality multidiciplinary in-hospital care and optimal long term rehabilitation is required. In this study, the investigators are moving the essential first diagnosis and treatment out into the community close to where the patient live, thus shortening the all important time from debut of symptoms to thrombolytic treatment improving the prognosis of stroke patients.
Detailed description
Stroke is an acute, potentially mutilating disease. To counteract long term sequelae three factors are essential: Ultrarapid diagnosis and treatment, high quality multidiciplinary in-hospital care and optimal long term rehabilitation. Initial diagnosis and treatment has up to now been completed within the hospital domain. This study will change that: moving the essential first diagnosis and treatment out into the community close to where the patient lives thus shortening the all important time from debut of symptoms to thrombolytic treatment. We will operate a local computer tomography (CT) service in the hands of community based non-specialized health care personnel (MD and nurse) acting under direct telemetric guidance from on call hospital specialists. Thus, the investigators will show that by combining current technological advances in real time video communication with an acutely well functioning cooperation between the community and hospital health service personnel the prognosis of stroke patients is improved.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Diagnostic Test: Rural CT scanningIntervention group: Stroke patients investigated with rural CT scanning at HSS, Ål. Patients living in the municipalities of Hol, Ål, Gol, Hemsedal and Nes. |
| 2 | – | –Control-group: Stroke patients with similar transportation time to hospital, but no access to rural CT scanning. Patients living in the municipalities of Nore- and Uvdal, Vang, Øystre and Vestre Slidre, Lesja, Vågå, Lom, Dovre, Skjåk and Sel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intervention group (access to local CT): Patients from the municipalities Hol, Ål, Gol, Hemsedal and Nes. Control group (no local CT): Patients from the municipalities Nore and Uvdal, Vang, Øystre- and Vestre Slidre, Lesja, Skjåk, Lom, Dovre, Vågå and Sel.
Key inclusion criteria (3 listed)
- Patients over 18 years being investigated by CT within 24 hours for acute symptoms of stroke.
- Fullfilling criteria for the diagnosis acute stroke as described by the Norwegian stroke registry.
- Giving informed consent.
Key exclusion criteria (3 listed)
- Symptoms not due to ischaemic or haemorrhagic stroke as adjudicated at discharge.
- Not able to cooperate to 3 months follow up.
- Not giving informed consent
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 |
|---|---|---|
| Rural CT scanningAlso: ThrombolysisRural computer tomography for acute stroke | Diagnostic test | 1 |
Primary outcome
Thrombolytic treatment
Time frame: 3 months
The proportion of patients with ischaemic stroke receiving thrombolytic treatment in percent.
4 secondary outcomes
Ictus to needle time
Time frame: 3 months
Functional status
Time frame: 3 months
Cognitive status
Time frame: 3 months
Depression
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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. This study is not recruiting at the moment.
Jorgen M Ibsen, MD principal investigator
Vestre Viken Hospital Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Vestre Viken Hospital Trust at 1 site 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombolytic treatment (time frame: 3 months). 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 14 Apr 2021.