Clinical trial NCT04917237: Non-disabling Ischemic Cerebrovascular Event With Apathy
Official title: Non-disabling Ischemic Cerebrovascular Event With Apathy: A Prospective Registry Trail
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Apathy
Minor Stroke
Transient Ischemic Attack
Stroke
Keywords: Apathy
minor stroke
Transient Ischemic Attack
Stroke
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults patients (≥18 years) within 1 month of onset of a minor stroke (National Institute of Health stroke scale, NIHSS≤3) and TIA.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Death
timeFrame: 1 month
measure: Death
timeFrame: 3 months
measure: Death
timeFrame: 6 months
measure: Death
timeFrame: 12 months
measure: Stroke recurrence
timeFrame: 1 month
measure: Stroke recurrence
timeFrame: 3 months
measure: Stroke recurrence
timeFrame: 6 months
measure: Stroke recurrence
timeFrame: 12 months
Secondary outcomes:
measure: Hemorrhagic stroke
timeFrame: 1 month
measure: Hemorrhagic stroke
timeFrame: 3 months
measure: Hemorrhagic stroke
timeFrame: 6 months
measure: Hemorrhagic stroke
timeFrame: 12 months
measure: Functional outcome
timeFrame: 1 month
measure: Functional outcome
timeFrame: 3 months
measure: Functional outcome
timeFrame: 6 months
measure: Functional outcome
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Department of Changhai Hospital
name: Xiaoying Bi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: