Rural CT Examination and Thrombolytic Treatment for Stroke | NCT03577847

Studies
Rural CT Examination and Thrombolytic Treatment for Stroke

NCT03577847

Sponsor

Vestre Viken Hospital Trust

Status

Unknown status

Last Update Posted

Apr 14, 2021Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Stroke

Interventions

Rural CT scanning

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 20, 2017Actual

Primary Completion Date

Apr 7, 2020Actual

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Jan 9, 2018

First Submission Date that Met QC Criteria

Jun 22, 2018

First Posted Date

Jul 5, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2021

Last Update Posted Date

Apr 14, 2021Actual

Name	Class
Extrastiftelsen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Rural CT scanning	Diagnostic Test	Rural computer tomography for acute stroke	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jorgen M Ibsen, MD	Vestre Viken Hospital Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vestre Viken Hospital Trust		Hønefoss	Buskerud	3004	Norway

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided