Trial record 15 of 254 for:    Transient Ischemic Attack

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Norwegian University of Science and Technology
Sponsor:
Collaborators:
St. Olavs Hospital
Helse Midt-Norge
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT02038725
First received: December 28, 2013
Last updated: July 21, 2014
Last verified: July 2014
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measured by using data from national health registries

  • Cost-benefit analysis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measured by using data from national health registries

  • Incidence of other vascular events within 1 year after transient ischemic attack [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Measured by using data from national health registries


Biospecimen Retention:   Samples Without DNA

Blood samples


Estimated Enrollment: 600
Study Start Date: October 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
TIA in last 2 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02038725

Contacts
Contact: Fredrik Ildstad, PhD student fredrik.ildstad@ntnu.no
Contact: Bent Indredavik, PhD, Prof bent.indredavik@ntnu.no

Locations
Norway
Kristiansund Sykehus Recruiting
Kristiansund, Norway
Levanger Sykehus Recruiting
Levanger, Norway
Molde Sykehus Recruiting
Molde, Norway
Namsos Sykehus Recruiting
Namsos, Norway
Orkdal Sykehus Recruiting
Orkanger, Norway
St Olavs Hospital Recruiting
Trondheim, Norway
Contact: Fredrik Ildstad       fredrik.ildstad@ntnu.no   
Volda Sykehus Recruiting
Volda, Norway
Ålesund Sykehus Recruiting
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:
No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT02038725     History of Changes
Other Study ID Numbers: 2012/1224
Study First Received: December 28, 2013
Last Updated: July 21, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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:
Ischemic Attack, Transient
Ischemia
Brain Ischemia
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014