Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03259737
Recruitment Status : Active, not recruiting
First Posted : August 24, 2017
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Ellen Bøhmer, Sykehuset Innlandet HF

Brief Summary:
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.

Condition or disease
Quality of Care Cerebrovascular Disorders Hyperglycemia Hypertension Troponin

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: An Observational Study of Stroke Patients With Focus on Examinations and Therapeutic Improvement the First 72 Hours.
Actual Study Start Date : May 1, 2018
Actual Primary Completion Date : November 15, 2018
Estimated Study Completion Date : December 1, 2020



Primary Outcome Measures :
  1. Number of supplementary computer tomography and magnetic resonance imaging of the brain. [ Time Frame: 3 months ]
    Number

  2. The number of blood sugar measurements [ Time Frame: 72 hours after admission to hospital ]
    Number


Secondary Outcome Measures :
  1. Troponin measurement, [ Time Frame: 72 hours ]
    frequency and level of max value

  2. Number of blood pressure measurement [ Time Frame: 72 hours ]
    Number

  3. Transfer to tertiary center [ Time Frame: 72 hours ]
    Number



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
All patients > 18 years, registered with a diagnosis of stroke during 2015 at Innlandet Hospital Trust Lillehammer.
Criteria

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.

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): NCT03259737


Locations
Layout table for location information
Norway
Innlandet Hospital Trust Lillehammer
Lillehammer, Norway, 2609
Ellen Bøhmer
Lillehammer, Norway
Sponsors and Collaborators
Ellen Bøhmer
Investigators
Layout table for investigator information
Study Director: Ingebjørg Hartz Sykehuset Innlandet HF
Layout table for additonal information
Responsible Party: Ellen Bøhmer, PHD cand med, Sykehuset Innlandet HF
ClinicalTrials.gov Identifier: NCT03259737    
Other Study ID Numbers: REK2015/358
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cerebrovascular Disorders
Hyperglycemia
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases