CompletedNot Applicable

Lleida TIA Intervention Study

100 participantsStarted 2011-03-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Controlled blood pressure

Timeframe: 12 months

Controlled LDL levels

Timeframe: 12 months

Trial details

NCT IDNCT04524078

SponsorInstitut de Recerca Biomèdica de Lleida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-01

View on ClinicalTrials.gov More Transient Ischemic Attack trials