Lleida TIA Intervention Study (LLETIS)

Integrated Care Improves Risk-factor Modification After Transient Ischemic Attack or Minor Stroke Patients (Lleida TIA Intervention Study)

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.

Study Overview

• Status: Completed
• Conditions: Transient Ischemic Attack
• Intervention / Treatment: Other: intensive integrated intervention care program

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intensive integrated intervention care program; 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	Other: intensive integrated intervention care program; 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
NO_INTERVENTION: Non intensive integrated intervention care program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	12 months
Controlled LDL levels	Rate of patients with controlled LDL-c (levels <100 mg/dl)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke recurrence	Rate of patients with stroke recurrence	12 months
Stroke recurrence	Rate of patients with stroke recurrence	5 years
Stroke recurrence	Rate of patients with stroke recurrence	10 years
Major vascular events	Rate of patients with stroke recurrence	12 months
Major vascular events	Rate of patients with stroke recurrence	5 years
Major vascular events	Rate of patients with stroke recurrence	10 years

Collaborators and Investigators

• Sponsor: Institut de Recerca Biomèdica de Lleida

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2011
• Primary Completion (ACTUAL): March 1, 2020
• Study Completion (ACTUAL): March 31, 2020

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: August 21, 2020
• First Posted (ACTUAL): August 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2020
• Last Update Submitted That Met QC Criteria: August 21, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: transient ischemic attack
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Ischemia; Ischemic Attack, Transient
• Other Study ID Numbers: LLETIS 1.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No