Lleida TIA Intervention Study

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04524078
Study type	Interventional
Source	Institut de Recerca Biomèdica de Lleida
Contact
Status	Completed
Phase	N/A
Start date	March 1, 2011
Completion date	March 31, 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT00859885` - International PFO Consortium	N/A
Not yet recruiting	`NCT03605355` - Feasibility Study on the Medical and Economic Consequences of Outpatient Management of TIAs and Minor Strokes
Completed	`NCT03281590` - Stroke and Cerebrovascular Diseases Registry
Completed	`NCT02905383` - The Effect of Exercise on Physical Function and Health in Older People After Discharge From Hospital	N/A
Completed	`NCT04078737` - Clopidogrel With Aspirin in High-risk Patients With Acute Non-disabling Cerebrovascular Events II	Phase 3
Completed	`NCT02141932` - Pocket-size Cardiovascular Ultrasound in Stroke	N/A
Recruiting	`NCT01954329` - Markers in the Diagnosis of TIA	N/A
Completed	`NCT02011256` - Early Detection Of Atrial Fibrillation In Patients With Transient Ischemic Attack	N/A
Completed	`NCT01918891` - Center for Stroke Disparities Solution - Community Transitions Intervention	N/A
Recruiting	`NCT01526824` - Lovaza's Effect on Clopidogrel in a Neuro Population	Phase 0
Completed	`NCT01020851` - The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating Transient Ischemic Attack (TIA) or Stroke Trial	N/A
Completed	`NCT00597974` - Neurological Outcome With Carotid Artery Stenting	N/A
Completed	`NCT00211731` - Preventing Recurrent Stroke in Minority Populations	N/A
Active, not recruiting	`NCT03635749` - Intensive Medical Therapy for High-risk Intracranial or Extracranial Atherosclerosis	Phase 3
Completed	`NCT03153020` - Determinants of Adherence to Post-stroke/Transient Ischemic Attack Secondary Prevention Treatment: Cohort Study in the Rhône
Recruiting	`NCT04075500` - Optimal Detection of Atrial Fibrillation in TIA	N/A
Recruiting	`NCT06091319` - Florbetaben for Imaging of Vascular Amyloid
Completed	`NCT04604015` - RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt	N/A
Completed	`NCT00885456` - Program of Rehabilitative Exercise and Education to Avert Vascular Events After Non-disabling Stroke or Transient Ischemic Attack: A Multi-site RCT	Phase 2
Recruiting	`NCT05620966` - EEG to Diagnose TIA and Stroke

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Lleida TIA Intervention Study — LLETIS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms