Rural CT Examination and Thrombolytic Treatment for Stroke (RURALCT)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke
• Intervention / Treatment: Diagnostic test: Rural CT scanning

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Norway
  • Buskerud
    • Honefoss, Buskerud, Norway, 3004
      • Vestre Viken Hospital Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Rural CT scanning; Rural computer tomography for acute stroke; Other Names: Thrombolysis
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thrombolytic treatment	The proportion of patients with ischaemic stroke receiving thrombolytic treatment in percent.	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vestre Viken Hospital Trust
• Collaborators: Extrastiftelsen
• Investigators: Principal Investigator: Jorgen M Ibsen, MD, Vestre Viken Hospital Trust

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2017
• Primary Completion (Actual): April 7, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: January 9, 2018
• First Submitted That Met QC Criteria: June 22, 2018
• First Posted (Actual): July 5, 2018

Study Record Updates

• Last Update Posted (Actual): April 14, 2021
• Last Update Submitted That Met QC Criteria: April 13, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Stroke, Thrombolysis, Rural CT
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: REK 2017/102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No