An Observational Study of Stroke Patients. (SPET-72)

An Observational Study of Stroke Patients With Focus on Examinations and Therapeutic Improvement the First 72 Hours.

The intention is to study presumed changes in daily practice, probably due to New Guidelines concerning stroke patients. The impression is more frequent measurements of blood pressure, serum glucose, troponin and supplementary computer tomography or magnetic resonance imaging.

Study Overview

• Status: Unknown
• Conditions: Hyperglycemia; Cerebrovascular Disorders; Hypertension; Troponin; Quality of Care

Detailed Description

There is in general a focus on misuse of health resources. An increasing amount of guidelines is produced to reduce the variation in treatment of patients with the same diagnosis. Many recommendations are weak but seems though to have considerable impact on in hospital care. The issues to be studied are all grounded on weak clinical evidence. A pilot study confirmed the suspicion of very frequent measurements of blood pressure, glucose, troponin and frequent supplementary CT and MRI. The intention is to study these issues in a larger population including an evaluation of utility of the different examinations and evaluations.

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Norway
  • Lillehammer, Norway, 2609
    • Innlandet hospital trust Lillehammer
  • Lillehammer, Norway
    • Ellen Bøhmer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients > 18 years, registered with a diagnosis of stroke during 2015 at Innlandet Hospital Trust Lillehammer.

Description

Inclusion Criteria:

• Patients with a diagnosis of stroke according to ICD 10th revision (code I61 I63 and I64)
• Hospitalized between January 1 and December 31, 2015

Exclusion Criteria:

• Previous hospitalization with a diagnosis of stroke in 2015.
• Foreigners and patients from other regions of Norway.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of supplementary computer tomography and magnetic resonance imaging of the brain.	Number	3 months
The number of blood sugar measurements	Number	72 hours after admission to hospital

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Troponin measurement,	frequency and level of max value	72 hours
Number of blood pressure measurement	Number	72 hours
Transfer to tertiary center	Number	72 hours

Collaborators and Investigators

• Sponsor: Ellen Bøhmer
• Investigators: Study Director: Ingebjørg Hartz, Sykehuset Innlandet HF

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): November 15, 2018
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: August 21, 2017
• First Posted (Actual): August 24, 2017

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 31, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hyperglycemia; Cerebrovascular Disorders
• Other Study ID Numbers: REK2015/358

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No