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Lleida TIA Intervention Study (LLETIS)

Primary Purpose

Transient Ischemic Attack

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
intensive integrated intervention care program
Sponsored by
Institut de Recerca Biomèdica de Lleida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Transient Ischemic Attack focused on measuring transient ischemic attack

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with transient ischemic attack (reversible episode of neurological deficit of ischemic origin that resolved completely within 24 hours) or minor stroke (established neurological deficit of ischemic origin with US National Institutes of Health stroke scale [NIHSS]score of 3 or less at the time of randomization)
  2. All subjects will be clinically evaluated by a stroke neurologist
  3. All subjects will be evaluated with CT scan or MRI to exclude other causes of neurological symptoms different than brain ischemia
  4. Patients with independence: modified Rankin score<3
  5. Patients with a critical carotid stenosis will be included after revascularization therapy
  6. Written informed consent

Exclusion Criteria:

  1. Having serious comorbidities: dementia, advanced Cancer, excessive intake of alcohol (> 280 gr/week), severe renal or hepatic insufficiency and severe cardiac failure
  2. Currently receiving an investigational drug or device
  3. Age<18 years
  4. Patient or family declining to take part
  5. Pregnant or breastfeeding
  6. Transient neurological deficit for < 5 minutes

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intensive integrated intervention care program

    Non intensive integrated intervention care program

    Arm Description

    intensive integrated intervention care program [ICP] (lifestyle changes, patient education, adherence to practical guidelines) to transient ischemic attack or minor stroke patients would modify a variety of vascular risk factors and therefore should decrease the likelihood of recurrent stroke or vascular events

    Outcomes

    Primary Outcome Measures

    Controlled blood pressure
    Rate of patients with controlled blood pressure values (Systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg) and controlled LDL-c (levels <100 mg/dl)
    Controlled LDL levels
    Rate of patients with controlled LDL-c (levels <100 mg/dl)

    Secondary Outcome Measures

    Stroke recurrence
    Rate of patients with stroke recurrence
    Stroke recurrence
    Rate of patients with stroke recurrence
    Stroke recurrence
    Rate of patients with stroke recurrence
    Major vascular events
    Rate of patients with stroke recurrence
    Major vascular events
    Rate of patients with stroke recurrence
    Major vascular events
    Rate of patients with stroke recurrence

    Full Information

    First Posted
    August 11, 2020
    Last Updated
    August 21, 2020
    Sponsor
    Institut de Recerca Biomèdica de Lleida
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04524078
    Brief Title
    Lleida TIA Intervention Study
    Acronym
    LLETIS
    Official Title
    Integrated Care Improves Risk-factor Modification After Transient Ischemic Attack or Minor Stroke Patients (Lleida TIA Intervention Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2011 (Actual)
    Primary Completion Date
    March 1, 2020 (Actual)
    Study Completion Date
    March 31, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Institut de Recerca Biomèdica de Lleida

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Having a transient ischemic attack (TIA) or a minor stroke is a real risk factor not only for early recurrent stroke but also for major extracranial vascular events. Despite these warning events provide an opportunity for prevention usual post-discharge care of these subjects (mainly at primary care) is not associated with an optimal control of cerebrovascular risk factors (CRF). The investigators hypothesized that patients exposed to the intensified integrated multifactorial interventional care program (ICP) model would exhibit better management of CRF and receive more targeted advice than patients receiving standard care. A second objective was to investigate the effect of the ICP model on stroke recurrence or the appearance of major extracranial vascular events. To test this hypothesis the investigators perform a controlled, randomized, single blind, parallel trial. Subjects are recruited at the Stroke Unit and are randomized into two groups: 1. usual care (control group) and 2. ICP (intervention group). Patients assigned to receive usual care (general practitioner with the possibility of being referred to specialists) are compared to those assigned to undergo ICP. This ICP involves strict treatment goals (LDL-cholesterol <100 mg/dl, blood pressure <130/80 mmHg, HbA1c<7%, no smoking, regular exercise and no excessive alcohol consumption) to be achieved through behavior modification (diet, physical activity, smoking cessation, alcohol cessation) and a stepwise introduction of pharmacologic therapy for the main CRF (hypercholesterolemia, hypertension and diabetes). This multifactorial intervention is overseen in each primary care center by a trained general practitioner and nursery. The treatment goals are the same for the control group and the intervention group. General practitioners caring patients of each group are informed of these strict treatment goals. Patients in the ICP group receive a minimum of four scheduled individual consultations in one year (baseline, 3, 6 and 9 months). Primary and secondary outcomes are evaluated by an external Neurologist at 12 months after their inclusion.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Transient Ischemic Attack
    Keywords
    transient ischemic attack

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    intensive integrated intervention care program [ICP] (lifestyle changes, patient education, adherence to practical guidelines) to transient ischemic attack or minor stroke patients would modify a variety of vascular risk factors and therefore should decrease the likelihood of recurrent stroke or vascular events
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intensive integrated intervention care program
    Arm Type
    Experimental
    Arm Description
    intensive integrated intervention care program [ICP] (lifestyle changes, patient education, adherence to practical guidelines) to transient ischemic attack or minor stroke patients would modify a variety of vascular risk factors and therefore should decrease the likelihood of recurrent stroke or vascular events
    Arm Title
    Non intensive integrated intervention care program
    Arm Type
    No Intervention
    Intervention Type
    Other
    Intervention Name(s)
    intensive integrated intervention care program
    Intervention Description
    intensive integrated intervention care program [ICP] (lifestyle changes, patient education, adherence to practical guidelines) to transient ischemic attack or minor stroke patients would modify a variety of vascular risk factors and therefore should decrease the likelihood of recurrent stroke or vascular events
    Primary Outcome Measure Information:
    Title
    Controlled blood pressure
    Description
    Rate of patients with controlled blood pressure values (Systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg) and controlled LDL-c (levels <100 mg/dl)
    Time Frame
    12 months
    Title
    Controlled LDL levels
    Description
    Rate of patients with controlled LDL-c (levels <100 mg/dl)
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Stroke recurrence
    Description
    Rate of patients with stroke recurrence
    Time Frame
    12 months
    Title
    Stroke recurrence
    Description
    Rate of patients with stroke recurrence
    Time Frame
    5 years
    Title
    Stroke recurrence
    Description
    Rate of patients with stroke recurrence
    Time Frame
    10 years
    Title
    Major vascular events
    Description
    Rate of patients with stroke recurrence
    Time Frame
    12 months
    Title
    Major vascular events
    Description
    Rate of patients with stroke recurrence
    Time Frame
    5 years
    Title
    Major vascular events
    Description
    Rate of patients with stroke recurrence
    Time Frame
    10 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with transient ischemic attack (reversible episode of neurological deficit of ischemic origin that resolved completely within 24 hours) or minor stroke (established neurological deficit of ischemic origin with US National Institutes of Health stroke scale [NIHSS]score of 3 or less at the time of randomization) All subjects will be clinically evaluated by a stroke neurologist All subjects will be evaluated with CT scan or MRI to exclude other causes of neurological symptoms different than brain ischemia Patients with independence: modified Rankin score<3 Patients with a critical carotid stenosis will be included after revascularization therapy Written informed consent Exclusion Criteria: Having serious comorbidities: dementia, advanced Cancer, excessive intake of alcohol (> 280 gr/week), severe renal or hepatic insufficiency and severe cardiac failure Currently receiving an investigational drug or device Age<18 years Patient or family declining to take part Pregnant or breastfeeding Transient neurological deficit for < 5 minutes

    12. IPD Sharing Statement

    Learn more about this trial

    Lleida TIA Intervention Study

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