Rural CT Examination and Thrombolytic Treatment for Stroke

• Conditions: Stroke
• Interventions: Diagnostic Test: Rural CT scanning

• Registration Number: NCT03577847
• Lead Sponsor: Vestre Viken Hospital Trust

Brief 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. 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 Timeline

• Study Start: 2017-11-20
• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-06-22
• Study First Posted: 2018-07-05
• Primary Completion: 2020-04-07
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-13
• Last Update Posted: 2021-04-14
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Patients over 18 years being investigated by CT within 24 hours for acute symptoms of stroke.
2. Fullfilling criteria for the diagnosis acute stroke as described by the Norwegian stroke registry.
3. Giving informed consent.

Exclusion Criteria

1. Symptoms not due to ischaemic or haemorrhagic stroke as adjudicated at discharge.
2. Not able to cooperate to 3 months follow up.
3. Not giving informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Rural CT scanning	Intervention group: Stroke patients investigated with rural CT scanning at HSS, Ål. Patients living in the municipalities of Hol, Ål, Gol, Hemsedal and Nes.

Primary Outcome Measures

Name	Time	Method
Thrombolytic treatment	3 months	The proportion of patients with ischaemic stroke receiving thrombolytic treatment in percent.

Secondary Outcome Measures

Name	Time	Method
Ictus to needle time	3 months	Time from onset of stroke symptoms (Ictus) to thrombolytic treatment (Needle).
Functional status	3 months	Modified Rankin Scale (mRS score 0-6). Good outcome 0-2
Cognitive status	3 months	Montreal Cognitive Assessment (MoCA score 0-30). Good outcome 26-30
Depression	3 months	Geriatric depression scale (GDS score 0-30). Good outcome 0-10

Trial Locations

Locations (1)

Vestre Viken Hospital Trust; 🇳🇴 Honefoss, Buskerud, Norway