Non-disabling Ischemic Cerebrovascular Event With Apathy

Sponsor
Changhai Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04917237
Collaborator
(none)
200
1
23
8.7

Study Details

Study Description

Brief Summary

The burden of non-disabling ischemic cerebrovascular events (NICE) is significantly increased. However, few previous studies have focused on affective impairment after transient ischemic attack (TIA) and minor stroke. Stroke survivors are often described as apathetic. Even though post-stroke apathy (PSA) affects one in three stroke patients,it has not hitherto received much attention. NICE-A is a prospective study aimed to explore the association between baseline apathy and probable incident stroke in a population-based sample of TIA and minor stroke adults.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Transient ischemic attack (TIA) and acute minor ischemic stroke, are common and may leave impermanent or mild neurological deficit, they are termed as non-disabling ischemic cerebrovascular disease (NICE). TIA and minor stroke exhibit the common substantial risk factors for early stroke recurrence and epidemiological characteristic, with approximately 10 to 20% of patients having a stroke within 3 months after the index event.

    Previous studies has shown that post-stroke apathy (PSA) affects one in three stroke patients, which is consistently associated with a worse level of functional recovery, poorer overall health and poorer quality of life. However, still little is known about the development of TIA and minor stroke patients with apathy. Thus, it is imperative to find the relationships between baseline PSA and probable incident stroke in these patients.

    NICE is an attractive researching area globally. According to the large quantities of NICE patients in China and the low standardized therapeutic rate, the awareness of TIA and minor stroke is largely insufficient. The purpose of the present NICE-A study is to establish the prevalence, predictors and evolution of symptoms of PSA in TIA and minor stroke patients during the first post-stroke year.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Non-disabling Ischemic Cerebrovascular Event With Apathy: A Prospective Registry Trail
    Actual Study Start Date :
    Jul 10, 2021
    Anticipated Primary Completion Date :
    Jun 10, 2022
    Anticipated Study Completion Date :
    Jun 10, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Death [1 month]

      Death from any cause

    2. Death [3 months]

      Death from any cause

    3. Death [6 months]

      Death from any cause

    4. Death [12 months]

      Death from any cause

    5. Stroke recurrence [1 month]

      Ischemic stroke

    6. Stroke recurrence [3 months]

      Ischemic stroke

    7. Stroke recurrence [6 months]

      Ischemic stroke

    8. Stroke recurrence [12 months]

      Ischemic stroke

    Secondary Outcome Measures

    1. Hemorrhagic stroke [1 month]

      Cerebral hemorrhage and subaraclmoid hemorrhage

    2. Hemorrhagic stroke [3 months]

      Cerebral hemorrhage and subaraclmoid hemorrhage

    3. Hemorrhagic stroke [6 months]

      Cerebral hemorrhage and subaraclmoid hemorrhage

    4. Hemorrhagic stroke [12 months]

      Cerebral hemorrhage and subaraclmoid hemorrhage

    5. Functional outcome [1 month]

      Modified Rankin Scale ≥3

    6. Functional outcome [3 months]

      Modified Rankin Scale ≥3

    7. Functional outcome [6 months]

      Modified Rankin Scale ≥3

    8. Functional outcome [12 months]

      Modified Rankin Scale ≥3

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    ≥18 years old Onset of a minor stroke (National Institute of Health stroke scale, NIHSS≤3) and TIA elapsed time from last episode to registry <1 month

    Exclusion Criteria:

    patients who refused to participate in the research, and patients who failed to complete the follow-up protocol.

    patients with malignant tumors, or patients with severe liver or kidney disease, whose life expectancy is less than 1 year.

    patients who received endovascular or thrombolytic therapy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Changhai Hospital Shanghai Shanghai China 200433

    Sponsors and Collaborators

    • Changhai Hospital

    Investigators

    • Principal Investigator: Xiaoying Bi, MD, PhD, Department of Changhai Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bingying Du, Professor, Changhai Hospital
    ClinicalTrials.gov Identifier:
    NCT04917237
    Other Study ID Numbers:
    • NICE-A
    First Posted:
    Jun 8, 2021
    Last Update Posted:
    Oct 21, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bingying Du, Professor, Changhai Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 21, 2021