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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

Tracking Information
First Submitted Date January 9, 2018
First Posted Date July 4, 2018
Last Update Posted Date March 15, 2019
Actual Study Start Date November 20, 2017
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 22, 2018)
Thrombolytic treatment [ Time Frame: 3 months ]
The proportion of patients with ischaemic stroke receiving thrombolytic treatment in percent.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03577847 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 13, 2019)
  • Ictus to needle time [ Time Frame: 3 months ]
    Time from onset of stroke symptoms (Ictus) to thrombolytic treatment (Needle).
  • Functional status [ Time Frame: 3 months ]
    Modified Rankin Scale (mRS score 0-6). Good outcome 0-2
  • Cognitive status [ Time Frame: 3 months ]
    Montreal Cognitive Assessment (MoCA score 0-30). Good outcome 26-30
  • Depression [ Time Frame: 3 months ]
    Geriatric depression scale (GDS score 0-30). Good outcome 0-10
Original Secondary Outcome Measures
 (submitted: June 22, 2018)
  • Ictus to needle time [ Time Frame: 3 months ]
    Time (minutes) from onset of stroke symptoms (Ictus) to thrombolytic treatment (needle).
  • Functional status [ Time Frame: 3 months ]
    Modified Rankin Scale (mRS)
  • Cognitive status [ Time Frame: 3 months ]
    Montreal Cognitive Assessment (MoCA)
  • Depression [ Time Frame: 3 months ]
    Rate of depression will be reported by geriatric depression scale (GDS)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Rural CT Examination and Thrombolytic Treatment for Stroke
Official Title Rural CT Examination and Thrombolytic Treatment for Stroke: An Observational Study of Medical and Health Economic Effects
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 Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 3 Months
Biospecimen Not Provided
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.

Condition Stroke
Intervention Diagnostic Test: Rural CT scanning
Rural computer tomography for acute stroke
Other Name: Thrombolysis
Study Groups/Cohorts
  • 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.
    Intervention: 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 22, 2018)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 1, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jorgen M Ibsen, MD 90732161 ext 0047 jorgen.ibsen@vestreviken.no
Contact: Christian Hall, PhD chal@vestreviken.no
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT03577847
Other Study ID Numbers REK 2017/102
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Vestre Viken Hospital Trust
Study Sponsor Vestre Viken Hospital Trust
Collaborators Extrastiftelsen
Investigators
Principal Investigator: Jorgen M Ibsen, MD Vestre Viken Hospital Trust
PRS Account Vestre Viken Hospital Trust
Verification Date March 2019