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Impact of Presenting Symptoms on Treatment Time and Outcomes in Acute Ischemic Stroke

2026年8月5日 更新者:Ahmad Ramadan Abdelazeem Saleh、Assiut University

Impact of Presenting Symptoms in Ischemic Stroke Onset on Time Treatment Window and Clinical Outcome of Acute Ischemic Stroke Patients

This observational study aims to understand how the specific symptoms a person experiences at the start of an acute ischemic stroke affect how quickly they receive treatment and how well they recover.

In stroke care, rapid treatment is critical because delayed intervention can lead to more severe disability or death. Patients who experience "high urgency" or classic stroke symptoms, such as sudden paralysis, severe facial drooping, or loss of speech, tend to arrive at the emergency room very quickly because these signs are easily recognized by bystanders. In contrast, patients who experience "low urgency" or vague symptoms, such as dizziness, numbness, visual changes, or a new-onset headache, often delay seeking medical care. Because these vague symptoms can mimic other medical conditions, they can lead to delayed diagnosis and longer waiting times for specific stroke treatments.

The researchers will observe 120 adult patients admitted for a first-ever acute ischemic stroke. Participants will be categorized into two groups based on whether their initial stroke symptoms were highly urgent or vague. The study will track and compare both groups to evaluate:

  • The time it takes for patients to arrive at the hospital and receive intervention therapies.
  • The patients' level of physical disability and independence in daily activities.
  • The patients' cognitive function.
  • The total length of the hospital stay, complication rates, and overall survival. Participants will be monitored from the time of their hospital admission through their discharge. To measure long-term recovery and functional outcomes, patients will also complete follow-up assessments at two weeks, one month, two months, and three months after leaving the hospital.

調査の概要

状態

まだ募集していません

研究の種類

観察的

入学 (推定)

120

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

なし

サンプリング方法

非確率サンプル

調査対象母集団

The study population consists of adult patients (aged 18 years and older) presenting with a first-ever acute ischemic stroke (AIS) who are admitted to the emergency department, neurology wards, or stroke unit within 48 hours of initial symptom onset. Diagnosis must be confirmed clinically and supported by objective neuroimaging findings via emergency CT or MRI scans. The population excludes patients with in-hospital stroke onset, transient ischemic attacks (TIAs), stroke mimics, severe pre-existing functional disability (defined as a baseline pre-stroke Modified Rankin Scale score > 2), and terminal co-morbidities with a life expectancy of less than 6 months.

説明

Inclusion Criteria:

  • Patients aged >= 18 years at the time of presentation.
  • Confirmed clinical diagnosis of acute first-ever ischemic stroke supported by objective neuroimaging findings via history case taking and emergency CT or MRI scans.
  • Hospital admission initiated within 48 hours of initial symptom onset.
  • Informed consent provided, signed, and dated by the patient or a legally authorized proxy representative.

Exclusion Criteria:

  • In-hospital stroke onset.
  • Diagnosis of a Transient Ischemic Attack (TIA) or presenting stroke mimics (e.g., complex migraines, severe hypoglycemia, conversion disorders, status epilepticus).
  • Pre-existing severe functional disability prior to the index stroke event, established as a baseline pre-stroke Modified Rankin Scale (mRS) score > 2.
  • Co-morbid advanced or terminal medical or neurological or psychiatric conditions with a documented clinical life expectancy of less than 6 months.
  • Incomplete medical charts, structural data gaps, or formal withdrawal on baseline assessment or on hospital stay assessment before discharge.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
High Urgency Symptoms
Patients with a first-ever acute ischemic stroke (AIS) presenting with "high urgency" classic symptoms, such as sudden hemiplegia/hemiparesis, severe facial droop, or profound aphasia. These patients are admitted for acute stroke management and will receive specific stroke interventions (e.g., rTPA or mechanical thrombectomy) if they meet the eligibility criteria.
Low Urgency or Vague Symptoms
Patients with a first-ever acute ischemic stroke (AIS) presenting with "low urgency" or vague symptoms, which may include sensory deficits, vestibular symptoms, visual disturbances, new-onset headache, wake-up strokes, or altered mental status. These patients are admitted for conventional ward care, undergoing a standard medical workup and generalized nursing management.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Functional Dependence Assessed by the Modified Rankin Scale (mRS)
時間枠:2 weeks after discharge
The degree of functional dependence and overall functional assessment of acute ischemic stroke patients will be estimated using the Modified Rankin Scale (mRS). Scores range from 0 to 6, where 0 represents no symptoms and 6 represents death, with higher scores indicating worse functional dependence.
2 weeks after discharge
Functional Dependence Assessed by the Modified Rankin Scale (mRS)
時間枠:1 month after discharge
The degree of functional dependence and overall functional assessment of acute ischemic stroke patients will be estimated using the Modified Rankin Scale (mRS). Scores range from 0 to 6, where 0 represents no symptoms and 6 represents death, with higher scores indicating worse functional dependence.
1 month after discharge
Functional Dependence Assessed by the Modified Rankin Scale (mRS)
時間枠:2 months after discharge
The degree of functional dependence and overall functional assessment of acute ischemic stroke patients will be estimated using the Modified Rankin Scale (mRS). Scores range from 0 to 6, where 0 represents no symptoms and 6 represents death, with higher scores indicating worse functional dependence.
2 months after discharge

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2027年9月1日

研究の完了 (推定)

2027年10月1日

試験登録日

最初に提出

2026年8月1日

QC基準を満たした最初の提出物

2026年8月5日

最初の投稿 (実際)

2026年8月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月6日

QC基準を満たした最後の更新が送信されました

2026年8月5日

最終確認日

2026年8月1日

詳しくは

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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