Intensive Treatment of Blood Pressure in Acute Ischemic Stroke. Study TICA 2
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Brain Ischemia
- Sponsor
- Manuel Rodríguez
- Enrollment
- 90
- Locations
- 3
- Primary Endpoint
- Study of functional prognosis in patients with acute ischemic stroke using modified Rankin
- Last Updated
- 8 years ago
Overview
Brief Summary
Demonstrate that maintenance of systolic blood pressure between 140 and 160 mm Hg during the acute phase of ischemic stroke is more effective than management according to the International Guideline (treat when systolic blood pressure exceeds 185 mm Hg)
Detailed Description
Control of blood pressure figures remains one of the most important risk factors in primary and secondary prevention in patients with stroke. The current strategy for the hypertensive treatment of patients during the acute phase of ischemic stroke within the first 72 hours remains a highly debated and unclear issue, with no consensus on the range or appropriate blood pressure ranges to be handled (13). Team study working hypothesis focuses on the study of blood pressure (for 72 hours), through its intensive control (recording and adjustment every four hours), in the acute phase of ischemic stroke. Specifically, it is based on the monitoring and maintenance of systolic blood pressure between 140 and 160 mm Hg in patients with acute ischemic stroke; And this can lead to a better functional prognosis, measured at 90 days, compared with the functional prognosis of patients treated according to the recommendations of the current Clinical Guidelines, which propose to act on systolic blood pressure only when it exceeds 185 mm Hg (13,22). Although the intense decrease in blood pressure during the acute phase of stroke has the potential risk of decreasing cerebral perfusion in the area of ischemic penumbra, in recent observational studies (19), a worse functional prognosis has not been found in those patients With systolic blood pressure above 140 mm Hg. There is no previous evidence from other intervention studies related to blood pressure control and a benefit to patients with acute ischemic stroke. Comparison using a randomized clinical trial of a group of patients with blood pressure control following current guidelines with a group of patients with systolic blood pressure between 140 and 160 mm Hg may allow a simple, rapidly applicable therapeutic alternative to Clinical practice, low cost and extrapolable to a wider population, such as patients with stroke of any etiology.
Investigators
Manuel Rodríguez
Principal Investigator
Hospital Clinico Universitario de Santiago
Eligibility Criteria
Inclusion Criteria
- •Men or women aged 18 years and up to and 85 years (both included).
- •Clinical and neuroimaging diagnosis (CT or MRI) of ischemic stroke.
- •Possibility of initiating antihypertensive treatment within 12 hours after the onset of symptoms (in the case of stroke, the start time is considered the time in that the patient has been seen asymptomatic for the last time).
- •Participant with systolic blood pressure greater than or equal to 140 mm Hg and less than or equal to 220 mm Hg at the time of inclusion.
- •Participant or legal representative able to understand the study requirements and sign Informed consent.
Exclusion Criteria
- •Uncontrollable hypertension (SBP greater than 220 mm Hg) or any condition requiring urgent antihypertensive treatment.
- •Have suffered a stroke in the previous 90 days in the same territory as the current stroke.
- •Had a myocardial infarction in the previous 90 days.
- •Suspected aortic dissection or hypertensive encephalopathy.
- •Presence of intracerebral or subarachnoid hemorrhage in basal neuroimaging (Computed tomography or magnetic resonance imaging).
- •Recanalization is possible or intraarterial recanalization techniques have been performed due to the current stroke.
- •Known critical carotid occlusion or stenosis.
- •To be a candidate for carotid revascularization in the next three months.
- •Previous alterations that, in the opinion of the investigator, may interfere in the interpretation of the neurological scales.
- •Coma or low level of consciousness (defined as a score ≥ 2 in section 1.a of NIHSS), dementia or mental disability that, in the opinion of the investigator, patient is unable to participate in the study.
Outcomes
Primary Outcomes
Study of functional prognosis in patients with acute ischemic stroke using modified Rankin
Time Frame: 90 days
Study of functional prognosis in patients with acute ischemic stroke using modified Rankin scale measured at 90 ± 15 days will compared between the two branches.Rankin Scale: It is a scale that evaluates the patient's functional situation. The full name is "modified Rankin Scale", and the abbreviated name is "mRS". The range of the scale is from 0 to 6, where 0 is the best score (the patient is asymptomatic) and 6 is the worst score (mortality). Up to 2 the patient is considered independent, and from 3 the patient needs help for the activities of daily life.
Secondary Outcomes
- Early Neurological Impairment (ENI)(72 hours)
- Volume of the infarct in neuroimaging(4th day)
- Mortality(90 days)
- Measuring the adverse events(90 days)
- Volume of the infarct using NIHSS(7th day)