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MIDNOR-TIA - a Study of 600 Patients With Transient Ischemic Attack (MIDNOR-TIA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02038725
First Posted: January 16, 2014
Last Update Posted: October 16, 2017
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.
Collaborators:
St. Olavs Hospital
Helse Midt-Norge
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  Purpose
Patients with a transient ischemic attack (TIA) are at high risk of stroke. Rapid assessment and treatment can reduce the risk. Several international guidelines recommend a test, the ABCD2 score, to identify TIA patients with low and high risk for stroke. The main purpose of this study is to investigate stroke risk after TIA in both short (1 week) and long term (3 months/1 year), and to assess whether the Age, Blood pressure, Clinical features, Duration of TIA, Diabetes (ABCD2) score is a sufficient tool for predicting stroke risk. Secondary aims are to explore whether adopting imaging modalities (ultrasound, MRI) and biological markers of blood into a risk score could improve the predictive value of the ABCD2 score and still be feasible in a daily clinical practice. Further on overall risk factors in TIA patients, and the incidence of other vascular events will be studied. A substudy designed as a randomised controlled trial evaluates pharmaceutical counseling in a subset of participants. Cost-benefit analysis, and a long-term follow-up (5 years) is planned.

Condition
Ischemic Attack, Transient Stroke

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: MIDNOR-TIA - a Prospective Cohort Study of 600 TIA Patients in Central Norway

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Number of patients presenting with stroke within 1 week after transient ischemic attack [ Time Frame: 1 week ]
    Measured by using data from the Norwegian Stroke Registry


Secondary Outcome Measures:
  • Number of patients presenting with stroke within 3 months after transient ischemic attack [ Time Frame: 3 months ]
    Measured by using data from the Norwegian Stroke Registry

  • Correlation between the ABCD2 score and the incidence of stroke within 1 week after transient ischemic attack [ Time Frame: 1 week ]
    Measured by comparing the ABCD2 score and the incidence of stroke within 1 week after transient ischemic attack based on data from the Norwegian Stroke Registry

  • Correlation between the ABCD2 score and the incidence of stroke within 3 months after transient ischemic attack [ Time Frame: 3 months ]
    Measured by comparing the ABCD2 score and the incidence of stroke within 3 months after transient ischemic attack based on data from the Norwegian Stroke Registry

  • Incidence of other vascular events within 1 week after transient ischemic attack [ Time Frame: 1 week ]
    Measured by using data from national health registries

  • Cost-benefit analysis [ Time Frame: 1 year ]
    Economic analysis that compares the costs of admission to hospital versus outpatient assessment of patients who have had transient ischemic attacks

  • Number of patients presenting with stroke within 1 year after transient ischemic attack [ Time Frame: 1 year ]
    Measured by using data from the Norwegian Stroke Registry

  • Correlation between the ABCD2 score and the incidence of stroke within 1 year after transient ischemic attack [ Time Frame: 1 year ]
    Measured by comparing the ABCD2 score and the incidence of stroke within 1 year after transient ischemic attack based on data from the Norwegian Stroke Registry

  • Incidence of other vascular events within 3 months after transient ischemic attack [ Time Frame: 3 months ]
    Measured by using data from national health registries

  • Incidence of other vascular events within 1 year after transient ischemic attack [ Time Frame: 1 year ]
    Measured by using data from national health registries


Biospecimen Retention:   Samples Without DNA
Blood samples

Enrollment: 584
Actual Study Start Date: October 2012
Study Completion Date: July 2015
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
TIA in last 2 weeks

  Eligibility

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.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred to a hospital in Central Norway with a recent probable or possible transient ischemic attack
Criteria

Inclusion Criteria:

  • Probable or possible transient ischemic attack
  • Residing in Central Norway
  • Examined within 2 weeks after the onset of symptoms
  • Modified Rankin Scale 3 or less and living at home
  • Informed consent
  Contacts and Locations
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): NCT02038725


Locations
Norway
Kristiansund Sykehus
Kristiansund, Norway
Levanger Sykehus
Levanger, Norway
Molde Sykehus
Molde, Norway
Namsos Sykehus
Namsos, Norway
Orkdal Sykehus
Orkanger, Norway
St Olavs Hospital
Trondheim, Norway
Volda Sykehus
Volda, Norway
Ålesund Sykehus
Ålesund, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Helse Midt-Norge
Investigators
Study Director: Bent Indredavik, PhD, Prof Norwegian University of Science and Technology
  More Information

Additional Information:
Publications:
Ildstad F, Ellekjaer H, Fjaertoft H, Indredavik B. MIDNOR TIA - a prospective cohort study of 586 patients, baseline data from a subgroup of 363 patients examined with diffusion-weighted imaging. International Journal of Stroke 10(suppl 2):242, 2015 (Meeting Abstract ESOC-1527)

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT02038725     History of Changes
Other Study ID Numbers: 2012/1224
First Submitted: December 28, 2013
First Posted: January 16, 2014
Last Update Posted: October 16, 2017
Last Verified: October 2017

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

Keywords provided by Norwegian University of Science and Technology:
Risks
Risk Factors
ABCD2 score
Predictive Value of Tests
Risk Assessment
Severity of Illness Index
Decision Support Techniques

Additional relevant MeSH terms:
Ischemia
Ischemic Attack, Transient
Pathologic Processes
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases