Non-disabling Ischemic Cerebrovascular Event With Apathy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Transient Ischemic Attack; Apathy; Minor Stroke

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Xiaoying Bi, MD, PhD; Phone Number: 86-13795274796; Email: bixiaoying2013@163.com
• Study Contact Backup: Name: Bingying Du, MD, PhD; Phone Number: 86-15800614142; Email: 15800614142@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Recruiting
      • Changhai hospital
      • Contact: Bingying Du, PhD; Phone Number: 15800614142; Email: 15800614142@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Death from any cause	12 months
Death	Death from any cause	3 months
Death	Death from any cause	6 months
Stroke recurrence	Ischemic stroke	3 months
Stroke recurrence	Ischemic stroke	6 months
Stroke recurrence	Ischemic stroke	12 months
Death	Death from any cause	1 month
Stroke recurrence	Ischemic stroke	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemorrhagic stroke	Cerebral hemorrhage and subaraclmoid hemorrhage	3 months
Hemorrhagic stroke	Cerebral hemorrhage and subaraclmoid hemorrhage	6 months
Hemorrhagic stroke	Cerebral hemorrhage and subaraclmoid hemorrhage	12 months
Functional outcome	Modified Rankin Scale ≥3	3 months
Functional outcome	Modified Rankin Scale ≥3	6 months
Functional outcome	Modified Rankin Scale ≥3	12 months
Hemorrhagic stroke	Cerebral hemorrhage and subaraclmoid hemorrhage	1 month
Functional outcome	Modified Rankin Scale ≥3	1 month

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 10, 2024

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 8, 2021

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 11, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: minor stroke; Stroke; Apathy; Transient Ischemic Attack
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Ischemia; Ischemic Attack, Transient
• Other Study ID Numbers: NICE-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No