Integrated Care Improves Risk-factor Modification After Transient Ischemic Attack or Minor Stroke Patients (Lleida TIA Intervention Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- Controlled blood pressure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Controlled blood pressure
时间窗: 12 months
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
时间窗: 12 months
Rate of patients with controlled LDL-c (levels \<100 mg/dl)
次要结局
- Stroke recurrence(10 years)
- Major vascular events(10 years)
研究者
Francisco Purroy
Principal investigator
Institut de Recerca Biomèdica de Lleida
