Lleida TIA Intervention Study

NCT04524078 | Completed DMC

• 1 other identifier: LLETIS 1.0
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Transient Ischemic Attack

Keywords

transient ischemic attack

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Stroke recurrence

  12 months

• Stroke recurrence

  5 years

• Stroke recurrence

  10 years

• Major vascular events

  12 months

• Major vascular events

  5 years

Study Arms (2)

Intensive integrated intervention care program

EXPERIMENTAL

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

Non intensive integrated intervention care program

NO INTERVENTION

Interventions

intensive integrated intervention care program OTHER

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

Intensive integrated intervention care program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de Recerca Biomèdica de Lleida: lead

MeSH Terms

Conditions

Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 24, 2020
• Study Start: March 1, 2011
• Primary Completion: March 1, 2020
• Study Completion: March 31, 2020
• Last Updated: August 24, 2020

Record last verified: 2020-08