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
About this trial
This is an interventional prevention trial for Transient Ischemic Attack focused on measuring transient ischemic attack
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
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
NCT ID
NCT04524078
First Posted
August 11, 2020
Last Updated
August 21, 2020
Sponsor
Institut de Recerca Biomèdica de Lleida
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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