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临床试验/CTRI/2024/02/062377
CTRI/2024/02/062377已完成不适用

Study of Three Month Outcome in Patients with Acute Stroke based On Intensive vs Standard Blood Pressure Control In a Tertiary Care Centre

Pt B D Sharma PGIMS Rohtak1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年2月10日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
1.Incidence of recurrent stroke

研究概览

简要总结

Hypertension is an important risk factor in the pathogenesis of both Ischemic and Hemorrhagic strokes . Thus the control of blood pressure becomes an important strategy in the prevention of stroke related co-morbidities. Our study aimed to find the impact of Intensive versus Standard BP Control on the functional status of post stroke patients measured by the mRS scale after 3 months of the index event . This was prospective comparative study where each patient was followed up for 3 months with regular OPD visits and telephonically .

 There was statistically significant difference between the mean SBP and mean DBP at baseline and at 1st , 2nd and 3rd month follow-up in both the Intensive and Standard BP Control Groups in the respective intra-group analysis. Inter-Group analysis  between the two groups revealed that there was no statistically significant difference in the mean SBP and DBP at baseline but on follow-up there was statistically significant difference between the mean SBP and mean DBP on all 3 follow up visits .

 The mean mRS of both the groups at baseline was 3.44 . The mean mRS of the Intensive versus the Standard BP Control Group at 3rd month follow up were 2.32 and 3.28 respectively with high statistical significance (p-value = 0.001) . There were no events of recurrent CVA during the three month follow up . Intensive BP Control was associated with improved mRS scores on three month follow up .

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Hypertensive patients (Known or newly detected) with acute stroke, both hemorrhagic and ischemic.

排除标准

  • Patients with traumatic brain injury
  • Presence of hemorrhagic complications during endovascular therapy
  • Severe or fatal comorbidities that would confound the outcome of the study (e.g. Malignancy that would affect mortality of the patients enrolled )
  • A pre-existing stroke disability defined by a modified Rankin Scale (mRS) score greater than two.

结局指标

主要结局

1.Incidence of recurrent stroke

时间窗: 3 months

2.Functional outcomes (measured by MRS scale) after 3 months

时间窗: 3 months

3. All Cause and CVA related Mortality

时间窗: 3 months

次要结局

  • 1. Extent of control of Hypertensive Status by various anti hypertensive regimens(3. Compliance to anti-hypertensive therapy)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Surekha Dabla

Pt B D Sharma, PGIMS , Rohtak-124001

研究点 (1)

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