ApathyNCT04917237
Non-disabling Ischemic Cerebrovascular Event With Apathy
An observational study of Apathy and Minor Stroke, run by Changhai Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Apathy, Minor Stroke, Transient Ischemic Attack
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2021to 10 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- ≥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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Bingying Du, PhD, 15800614142, 15800614142@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Apathy, Minor Stroke, Transient Ischemic Attack, Stroke
- Keywords
- Apathy, minor stroke, Transient Ischemic Attack, Stroke
- Medical subject headings
- Lethargy, Ischemic Attack, Transient, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Death from any cause
Measured: 1 month
Death
Death from any cause
Measured: 3 months
Death
Death from any cause
Measured: 6 months
Death
Death from any cause
Measured: 12 months
Stroke recurrence
Ischemic stroke
Measured: 1 month
Stroke recurrence
Ischemic stroke
Measured: 3 months
Stroke recurrence
Ischemic stroke
Measured: 6 months
Stroke recurrence
Ischemic stroke
Measured: 12 months
Secondary outcomes (8)
Hemorrhagic stroke
Cerebral hemorrhage and subaraclmoid hemorrhage
Measured: 1 month
Hemorrhagic stroke
Cerebral hemorrhage and subaraclmoid hemorrhage
Measured: 3 months
Hemorrhagic stroke
Cerebral hemorrhage and subaraclmoid hemorrhage
Measured: 6 months
Hemorrhagic stroke
Cerebral hemorrhage and subaraclmoid hemorrhage
Measured: 12 months
Functional outcome
Modified Rankin Scale ≥3
Measured: 1 month
Functional outcome
Modified Rankin Scale ≥3
Measured: 3 months
Functional outcome
Modified Rankin Scale ≥3
Measured: 6 months
Functional outcome
Modified Rankin Scale ≥3
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start10 Jul 2021
- Primary completion1 Jun 2024 (estimated)
- Study completion10 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ApathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bingying Du, Changhai Hospital
- Investigators
- Xiaoying Bi, MD, PhD, Principal investigator, Department of Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917237
- Sponsor's protocol ID
- NICE-A
- Status last verified
- Feb 2024
- First submitted
- 2 Jun 2021
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-disabling Ischemic Cerebrovascular Event With Apathy: A Prospective Registry Trail
- ClinicalTrials.gov ID
- NCT04917237
- Acronym / sponsor ID
- NICE-A
- Conditions
- Apathy, Minor Stroke, Transient Ischemic Attack, Stroke
- Keywords
- Apathy, minor stroke, Transient Ischemic Attack, Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 10 Jul 2021 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 10 Jun 2024 (estimated)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- ≥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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death
Time frame: 1 month
Death from any cause
Death
Time frame: 3 months
Death from any cause
Death
Time frame: 6 months
Death from any cause
Death
Time frame: 12 months
Death from any cause
Stroke recurrence
Time frame: 1 month
Ischemic stroke
Stroke recurrence
Time frame: 3 months
Ischemic stroke
Stroke recurrence
Time frame: 6 months
Ischemic stroke
Stroke recurrence
Time frame: 12 months
Ischemic stroke
8 secondary outcomes
Hemorrhagic stroke
Time frame: 1 month
Hemorrhagic stroke
Time frame: 3 months
Hemorrhagic stroke
Time frame: 6 months
Hemorrhagic stroke
Time frame: 12 months
Functional outcome
Time frame: 1 month
Functional outcome
Time frame: 3 months
Functional outcome
Time frame: 6 months
Functional outcome
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoying Bi, MD, PhD principal investigator
Department of Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apathy and Minor Stroke, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoying Bi, MD, PhD (86-13795274796, bixiaoying2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 1 month). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.