Ischemic StrokeREACHNCT03024164
Stroke Registration of Young Adults in China
An observational study of Ischemic Stroke, run by Yi Yang at 1 site in China.
Trial summary
This is a multi-center, prospective,continuous registry study. The investigators will include 3000 young adult (18-45 years old) patients with confirmed first-ever acute ischemic stroke in China. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Treatment following current guidelines
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 26 Nov 2017to 31 Jul 2025
- How long will I take part?
- 1 Year
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Young adult patients who had their first-ever ischemic stroke symptoms within 72 hours and visited one of the 22 participating medical centers in People's Republic of China.
Who may be able to join
- Age 18 through 45 years, both genders
- First-ever acute ischemic stroke
- Onset of symptoms within 72 hours of inclusion
- Willing to participate in follow-up visits
Who cannot join
- Silent stroke
- Failure to give their informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Hospital of Jilin University
Changchun, Jilin, 130000
Yi Yang, MD, PhD, +86-18186870008, doctoryangyi@163.com
About this study
This is a multi-center, prospective,continuous registry study. The investigators will include 3000 young adult (18-45 years old) patients with confirmed first-ever acute ischemic stroke in China. The main purpose of this study is to build the study cohort of young ischemic stroke patients in China, and to compare the prognosis and stroke recurrence of young patients with different ischemic stroke subtypes. Secondary objectives are trying to find biomarkers of stroke recurrence.
Read the detailed description
Approximately 10%-14% of all ischemic strokes occur in young adults ages 18 to 45 years old. Stroke etiology in this population differs by geographic region and has greater heterogeneity than in older individuals. Ascertain the definite etiologic classification in this young patients might be the key point to prevent the stroke recurrence and reduce the stroke burden. Advances in stroke diagnostic tests, particularly neuroimaging, refinement in classification schema. In this multi-center registry study conducted in China, we determine to explore the difference of prognosis and stroke recurrence of young patients with different ischemic stroke subtypes.
- Conditions
- Ischemic Stroke
- Being tested
- Treatment following current guidelines
- Keywords
- youth; etiology; prognosis; recurrence; biomarkers
- Medical subject headings
- Ischemic Stroke, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment following current guidelinesOther
Treatment following current guidelines
| Study group | Role | What they receive |
|---|---|---|
| Young adult stroke patients | Young adult (18-45 years old) patients with confirmed first-ever acute ischemic stroke Receives: Other: Treatment following current guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke recurrence
Percentage of patients with the 1 year new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage)
Measured: 1 year
Post-stroke disability
Modified Rankin Scale score changes (continuous) and dichotomized at percentage with score 0-2 vs. 3-6 at 3-month follow-up.
Measured: 3 months
Secondary outcomes (3)
Cardiovascular death
Percentage of patients with the 3-month, 6-month and 1 year cardiovascular death caused by any event of the following: Any stroke (ischemic or hemorrhage), sudden cardiac death, acute myocardial infarction, heart failure, and other cardiovascular death including pulmonary embolism, rupture of aortic aneurysm, cardiovascular interventional therapy, and peripheral arterial disease.
Measured: 3 months, 6 months and 1 year
Other cardiovascular event
Percentage of patients with the 3-month, 6-month and 1 year other cardiovascular event including non-lethal myocardial infarction, and non fatal heart failure.
Measured: 3 months, 6 months and 1 year
Other systemic embolism
Percentage of patients with the 3-month, 6-month and 1 year other systemic embolism except for cerebral artery, coronary artery, and pulmonary artery. Such as mesenteric arterial embolism,splenic artery embolization.
Measured: 3 months, 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study start26 Nov 2017
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Yi Yang
- Sponsor type
- University, hospital or other
- Collaborators
- Jiujiang No.1 People's Hospital, Dezhou People's Hospital, The Affiliated Hospital of Yanbian University, First Affiliated Hospital of Jiamusi University, Xuchang Central Hospital, Inner Mongolia People's Hospital, Shaoxing People's Hospital, Chinese PLA General Hospital, General Hospital of Ningxia Medical University, General Hospital of Shenyang Military Region, Siping Central People's Hospital, The First Affiliated Hospital of Shihezi University, Daqing Oil Field Hospital, Heilongjiang Provicial Hospital, The First Affiliated Hospital of Soochow University, Luoyang Central Hospital Affilated to Zhengzhou University, Wuzhou Red Cross Hospital, Cangzhou Central Hospital, Binzhou Medical University, Affilated Hospital of Inner Mongolia University for the Nationalities, Fudan University Pudong Medical Center
- Responsible party
- Sponsor-investigator, Yi Yang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024164
- Sponsor's protocol ID
- REACH
- Acronym
- REACH
- Status last verified
- Feb 2024
- First submitted
- 15 Jan 2017
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Registration of Young Adults in China
- ClinicalTrials.gov ID
- NCT03024164
- Acronym / sponsor ID
- REACH / REACH
- Conditions
- Ischemic Stroke
- Keywords
- youth; etiology; prognosis; recurrence; biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Yi YangUniversity, hospital or other
- Collaborators
- Jiujiang No.1 People's Hospital, Dezhou People's Hospital, The Affiliated Hospital of Yanbian University, First Affiliated Hospital of Jiamusi University, Xuchang Central Hospital, Inner Mongolia People's Hospital, Shaoxing People's Hospital, Chinese PLA General Hospital, General Hospital of Ningxia Medical University, General Hospital of Shenyang Military Region, Siping Central People's Hospital, The First Affiliated Hospital of Shihezi University, Daqing Oil Field Hospital, Heilongjiang Provicial Hospital, The First Affiliated Hospital of Soochow University, Luoyang Central Hospital Affilated to Zhengzhou University, Wuzhou Red Cross Hospital, Cangzhou Central Hospital, Binzhou Medical University, Affilated Hospital of Inner Mongolia University for the Nationalities, Fudan University Pudong Medical Center
- Study start
- 26 Nov 2017 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 18 Jan 2017 (estimated)
- 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.
This is a multi-center, prospective,continuous registry study. The investigators will include 3000 young adult (18-45 years old) patients with confirmed first-ever acute ischemic stroke in China. The main purpose of this study is to build the study cohort of young ischemic stroke patients in China, and to compare the prognosis and stroke recurrence of young patients with different ischemic stroke subtypes. Secondary objectives are trying to find biomarkers of stroke recurrence.
Detailed description
Approximately 10%-14% of all ischemic strokes occur in young adults ages 18 to 45 years old. Stroke etiology in this population differs by geographic region and has greater heterogeneity than in older individuals. Ascertain the definite etiologic classification in this young patients might be the key point to prevent the stroke recurrence and reduce the stroke burden. Advances in stroke diagnostic tests, particularly neuroimaging, refinement in classification schema. In this multi-center registry study conducted in China, we determine to explore the difference of prognosis and stroke recurrence of young patients with different ischemic stroke subtypes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young adult stroke patients | – | Other: Treatment following current guidelinesYoung adult (18-45 years old) patients with confirmed first-ever acute ischemic stroke |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Young adult patients who had their first-ever ischemic stroke symptoms within 72 hours and visited one of the 22 participating medical centers in People's Republic of China.
Key inclusion criteria (4 listed)
- Age 18 through 45 years, both genders
- First-ever acute ischemic stroke
- Onset of symptoms within 72 hours of inclusion
- Willing to participate in follow-up visits
Key exclusion criteria (2 listed)
- Silent stroke
- Failure to give their informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment following current guidelinesTreatment following current guidelines | Other | Young adult stroke patients |
Primary outcome
Stroke recurrence
Time frame: 1 year
Percentage of patients with the 1 year new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage)
Post-stroke disability
Time frame: 3 months
Modified Rankin Scale score changes (continuous) and dichotomized at percentage with score 0-2 vs. 3-6 at 3-month follow-up.
3 secondary outcomes
Cardiovascular death
Time frame: 3 months, 6 months and 1 year
Other cardiovascular event
Time frame: 3 months, 6 months and 1 year
Other systemic embolism
Time frame: 3 months, 6 months and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Individual participant dataSharing planned: No
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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.
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 Ischemic Stroke, run by Yi Yang 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 4 inclusion and 2 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 1 Mar 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 Yi Yang, MD,PhD (+86-18186870008, doctor_yangyi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke recurrence (time frame: 1 year). The study lists 2 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 1 Mar 2024.