Non-disabling Ischemic Cerebrovascular Event With Apathy

Stroke Clinical Trial

Official title:

Non-disabling Ischemic Cerebrovascular Event With Apathy: A Prospective Registry Trail

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04917237
• Other study ID #: NICE-A
• Status: Recruiting
• Start date: July 10, 2021
• Est. completion date: June 10, 2024

Study information

• Verified date: February 2024
• Source: Changhai Hospital
• Contact: Xiaoying Bi, MD, PhD
• Phone: 86-13795274796
• Email: bixiaoying2013[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 10, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apathy
• Ischemia
• Ischemic Attack, Transient
• Minor Stroke
• Stroke
• Transient Ischemic Attack

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	Death from any cause	1 month
Primary	Death	Death from any cause	3 months
Primary	Death	Death from any cause	6 months
Primary	Death	Death from any cause	12 months
Primary	Stroke recurrence	Ischemic stroke	1 month
Primary	Stroke recurrence	Ischemic stroke	3 months
Primary	Stroke recurrence	Ischemic stroke	6 months
Primary	Stroke recurrence	Ischemic stroke	12 months
Secondary	Hemorrhagic stroke	Cerebral hemorrhage and subaraclmoid hemorrhage	1 month
Secondary	Hemorrhagic stroke	Cerebral hemorrhage and subaraclmoid hemorrhage	3 months
Secondary	Hemorrhagic stroke	Cerebral hemorrhage and subaraclmoid hemorrhage	6 months
Secondary	Hemorrhagic stroke	Cerebral hemorrhage and subaraclmoid hemorrhage	12 months
Secondary	Functional outcome	Modified Rankin Scale =3	1 month
Secondary	Functional outcome	Modified Rankin Scale =3	3 months
Secondary	Functional outcome	Modified Rankin Scale =3	6 months
Secondary	Functional outcome	Modified Rankin Scale =3	12 months