Rural CT Examination and Thrombolytic Treatment for Stroke

NCT03577847 | Unknown

• 1 other identifier: REK 2017/102
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke, Thrombolysis, Rural CT

Outcome Measures

Primary Outcomes (1)

• Thrombolytic treatment

  The proportion of patients with ischaemic stroke receiving thrombolytic treatment in percent.

  3 months

Secondary Outcomes (4)

• Ictus to needle time

  3 months

• Functional status

  3 months

• Cognitive status

  3 months

• Depression

  3 months

Study Arms (2)

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

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.

Interventions

Rural CT scanning DIAGNOSTIC_TEST

Rural computer tomography for acute stroke

Also known as: Thrombolysis

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vestre Viken Hospital Trust: lead
• Extrastiftelsen: collaborator

Study Sites (1)

Vestre Viken Hospital Trust

Hønefoss, Buskerud, 3004, Norway

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jorgen M Ibsen, MD

  Vestre Viken Hospital Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: July 5, 2018
• Study Start: November 20, 2017
• Primary Completion: April 7, 2020
• Study Completion: December 31, 2021
• Last Updated: April 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)