Rural CT Examination and Thrombolytic Treatment for Stroke

Stroke Clinical Trial

— RURALCT  

Official title:

Rural CT Examination and Thrombolytic Treatment for Stroke: An Observational Study of Medical and Health Economic Effects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03577847
• Other study ID #: REK 2017/102
• Status: Active, not recruiting
• Start date: November 20, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2021
• Source: Vestre Viken Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 31, 2021
• Est. primary completion date: April 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Diagnostic Test:
• Rural CT scanning
Rural computer tomography for acute stroke

Locations

Country	Name	City	State
Norway	Vestre Viken Hospital Trust	Honefoss	Buskerud

Sponsors (2)

Lead Sponsor	Collaborator
Vestre Viken Hospital Trust	Extrastiftelsen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thrombolytic treatment	The proportion of patients with ischaemic stroke receiving thrombolytic treatment in percent.	3 months
Secondary	Ictus to needle time	Time from onset of stroke symptoms (Ictus) to thrombolytic treatment (Needle).	3 months
Secondary	Functional status	Modified Rankin Scale (mRS score 0-6). Good outcome 0-2	3 months
Secondary	Cognitive status	Montreal Cognitive Assessment (MoCA score 0-30). Good outcome 26-30	3 months
Secondary	Depression	Geriatric depression scale (GDS score 0-30). Good outcome 0-10	3 months