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Rural CT Examination and Thrombolytic Treatment for Stroke (RURALCT)

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ClinicalTrials.gov Identifier: NCT03577847
Recruitment Status : Recruiting
First Posted : July 4, 2018
Last Update Posted : March 15, 2019
Sponsor:
Collaborator:
Extrastiftelsen
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Stroke 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Rural CT Examination and Thrombolytic Treatment for Stroke: An Observational Study of Medical and Health Economic Effects
Actual Study Start Date : November 20, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : April 1, 2021

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 Name: 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.



Primary Outcome Measures :
  1. Thrombolytic treatment [ Time Frame: 3 months ]
    The proportion of patients with ischaemic stroke receiving thrombolytic treatment in percent.


Secondary Outcome Measures :
  1. Ictus to needle time [ Time Frame: 3 months ]
    Time from onset of stroke symptoms (Ictus) to thrombolytic treatment (Needle).

  2. Functional status [ Time Frame: 3 months ]
    Modified Rankin Scale (mRS score 0-6). Good outcome 0-2

  3. Cognitive status [ Time Frame: 3 months ]
    Montreal Cognitive Assessment (MoCA score 0-30). Good outcome 26-30

  4. Depression [ Time Frame: 3 months ]
    Geriatric depression scale (GDS score 0-30). Good outcome 0-10



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03577847


Contacts
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Contact: Jorgen M Ibsen, MD 90732161 ext 0047 jorgen.ibsen@vestreviken.no
Contact: Christian Hall, PhD chal@vestreviken.no

Locations
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Norway
Vestre Viken Hospital Trust Recruiting
Honefoss, Buskerud, Norway, 3004
Contact: Christian M Hall, PhD       chal@vestreviken.no   
Contact: Jorgen Ibsen, MD       jorgen.ibsen@vestreviken.no   
Sponsors and Collaborators
Vestre Viken Hospital Trust
Extrastiftelsen
Investigators
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Principal Investigator: Jorgen M Ibsen, MD Vestre Viken Hospital Trust

Additional Information:

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Responsible Party: Vestre Viken Hospital Trust
ClinicalTrials.gov Identifier: NCT03577847     History of Changes
Other Study ID Numbers: REK 2017/102
First Posted: July 4, 2018    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vestre Viken Hospital Trust:
Stroke, Thrombolysis, Rural CT

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action