Risk stratification and early complication prediction in acute stroke patients using integrated scoring models
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1) Functional outcome at 90 days — measured by Modified Rankin Scale (mRS) score at baseline (on admission), 14 days, and 90 days.
研究概览
简要总结
This is a prospective, comparative, followup study designed to evaluate the effectiveness of an app-based integrated scoring system Stroke360 in predicting early and late complications among patients with acute stroke. The mobile application automatically computes validated risk scores such as NIHSS, mRS, A2DS2, HAT, SeLECT, SOAR, and iScore from structured clinical data to assist in real time risk stratification and complication prediction.Sixty adult patients with confirmed acute stroke will be enrolled and divided into two groups: one receiving app-assisted monitoring Stroke360 group and the other receiving standard care control group. Each patient will be followed up at 14 days and 90 days after admission to assess neurological recovery, functional outcome, and occurrence of complications.The study aims to determine whether continuous, app-based monitoring improves early complication detection, functional recovery, medication adherence, and overall outcome compared to usual stroke care. Findings will help establish an evidence based digital tool for integrated stroke risk management and prognosis prediction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically and radiologically confirmed diagnosis with acute ischaemic stroke.
- •Ability to consent 3)Haemodynamically stable.
排除标准
- •Age above 80 years or age less than 18 years 2)nability to consent 3)Stroke mimics ( e.g., seizures, migraines) 4)Patient with incomplete clinical or imaging records.
结局指标
主要结局
1) Functional outcome at 90 days — measured by Modified Rankin Scale (mRS) score at baseline (on admission), 14 days, and 90 days.
时间窗: Baseline (Day 0), Day 14, and Day 90.
2) Incidence of early and late complications among acute stroke patients, including stroke-associated pneumonia, symptomatic intracerebral hemorrhage (sICH), recurrent stroke, and post-stroke seizures — assessed during hospitalization (up to 14 days) and at 3 months follow-up.
时间窗: Baseline (Day 0), Day 14, and Day 90.
次要结局
- Change in NIHSS and mRS scores from baseline to 90 days, medication and rehabilitation adherence rates (via app data), readmission and mortality within 90 days, and correlation of integrated risk scores (A2DS2, HAT, SeLECT, SOAR, iScore) with actual early and late complications.(Baseline (Day 0), Day 14, and Day 90.)
研究者
Dr AVINASH P V
SAVEETHA MEDICAL COLLEGE AND HOSPITAL