StrokeSECRETS-TCMNCT03380481
SouthErn China REgisTry for Stroke on Traditional Chinese Medicine
An observational study of Stroke and Cerebral Infarction, run by Yefeng Cai at 1 site in China.
Trial summary
Stroke is the first most common cause of death in China and one of the major causes of functional disability in the adult population.The burden of stoke is significantly increased in China in recent years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cerebral Infarction, Transient Ischemic Attack
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2018to 31 Dec 2020
- How long will I take part?
- 24 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be comprised of those who meet all inclusion criteria and no exclusion criteria. Study personnel will continuously screen eligible patients presenting to the hospitals until the sample size of 10000 is reached. This study will be conducted in more than 50 hopitals in southern China.
Who may be able to join
- ≥18 years.
- Patients within 14 days of onset of acute stroke (including acute cerebral infarction, transient ischemic attack, acute cerebral hemorrhage, acute subarachnoid hemorrhage).
- The patient and/or guardian agree to participate in this study.
Who cannot join
- Patients with silent cerebrovascular disease.
- Patients with non-cerebrovascular disease events.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wuyi Traditional Chinese Medicine Hospital of Jiangmen
Jiangmen, Guangdong, 529000
Qing Shi, M.D., +86 13923082181, Jmsq27@126.com
About this study
Stroke is the first most common cause of death in China and one of the major causes of functional disability in the adult population.The burden of stoke is significantly increased in China in recent years.
In order to investigate the prognosis of stroke, with diagnostic and treatment information of traditional Chinese medicine (TCM), and assess the effectiveness and safety of TCM for stroke in southern China, the investigators will conduct this multicenter prospective registry study in southern China. This study will recruit 10,000 consecutive eligible patients with acute stroke from more than 50 hospitals. 24 months follow-up will be carried out on-site in hospitals and by telephone to track endpoint (including all-cause mortality, composite cerebrovascular and cardiovascular events at one and two year follow up, and neurological and functional assessments).
- Conditions
- Stroke, Cerebral Infarction, Transient Ischemic Attack, Cerebral Hemorrhage, Subarachnoid Hemorrhage
- Being tested
- observational only-no intervention
- Medical subject headings
- Stroke, Cerebral Infarction, Ischemic Attack, Transient, Cerebral Hemorrhage, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational only-no interventionOther
Observational only and no predesigned interventions in this study.
| Study group | Role | What they receive |
|---|---|---|
| SECRETS-TCM | Stroke patients who treated by western medicine and/or traditional Chinese medicine in southern China Receives: Other: observational only-no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: 12 months follow-up
Composite cerebrovascular and cardiovascular events
Including stroke recurrence events,acute myocardial infarction and cardiac death
Measured: 12 months follow-up
Secondary outcomes (11)
All-cause mortality
Measured: 24 months follow-up
Composite cerebrovascular and cardiovascular events
Including stroke recurrence events,acute myocardial infarction and cardiac death
Measured: 24 months follow-up
Modified Rankin Scale(mRS)
Range:Grade 0 to Grade 6, higher grade represent a worse outcome
Measured: 3 months follow-up
Barthel Index(BI)
Range:0 to 100 points, higher points represent a better outcome
Measured: 3 months follow-up
Mini-Mental State Examination(MMSE)
Range:0 to 30 points, higher points represent a better outcome
Measured: 3 months follow-up
Modified Rankin Scale(mRS)
Range:Grade 0 to Grade 6, higher grade represent a worse outcome
Measured: 12 months follow-up
Barthel Index(BI)
Range:0 to 100 points, higher points represent a better outcome
Measured: 12 months follow-up
Mini-Mental State Examination(MMSE)
Range:0 to 30 points, higher points represent a better outcome
Measured: 12 months follow-up
Modified Rankin Scale(mRS)
Range:Grade 0 to Grade 6, higher grade represent a worse outcome
Measured: 24 months follow-up
Barthel Index(BI)
Range:0 to 100 points, higher points represent a better outcome
Measured: 24 months follow-up
Mini-Mental State Examination(MMSE)
Range:0 to 30 points, higher points represent a better outcome
Measured: 24 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start15 Jan 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Yefeng Cai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yefeng Cai, Guangzhou University of Traditional Chinese Medicine
- Investigators
- Yefeng Cai, M.D.,Ph D, Principal investigator, Guangdong Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380481
- Sponsor's protocol ID
- 201604020003
- Acronym
- SECRETS-TCM
- Status last verified
- Mar 2018
- First submitted
- 13 Dec 2017
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SouthErn China REgisTry for Stroke on Traditional Chinese Medicine
- ClinicalTrials.gov ID
- NCT03380481
- Acronym / sponsor ID
- SECRETS-TCM / 201604020003
- Conditions
- Stroke, Cerebral Infarction, Transient Ischemic Attack, Cerebral Hemorrhage, Subarachnoid Hemorrhage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Yefeng CaiUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 21 Dec 2017 (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.
Stroke is the first most common cause of death in China and one of the major causes of functional disability in the adult population.The burden of stoke is significantly increased in China in recent years.
In order to investigate the prognosis of stroke, with diagnostic and treatment information of traditional Chinese medicine (TCM), and assess the effectiveness and safety of TCM for stroke in southern China, the investigators will conduct this multicenter prospective registry study in southern China. This study will recruit 10,000 consecutive eligible patients with acute stroke from more than 50 hospitals. 24 months follow-up will be carried out on-site in hospitals and by telephone to track endpoint (including all-cause mortality, composite cerebrovascular and cardiovascular events at one and two year follow up, and neurological and functional assessments).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SECRETS-TCM | – | Other: observational only-no interventionStroke patients who treated by western medicine and/or traditional Chinese medicine in southern China |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be comprised of those who meet all inclusion criteria and no exclusion criteria. Study personnel will continuously screen eligible patients presenting to the hospitals until the sample size of 10000 is reached. This study will be conducted in more than 50 hopitals in southern China.
Key inclusion criteria (3 listed)
- ≥18 years.
- Patients within 14 days of onset of acute stroke (including acute cerebral infarction, transient ischemic attack, acute cerebral hemorrhage, acute subarachnoid hemorrhage).
- The patient and/or guardian agree to participate in this study.
Key exclusion criteria (2 listed)
- Patients with silent cerebrovascular disease.
- Patients with non-cerebrovascular disease events.
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 |
|---|---|---|
| observational only-no interventionObservational only and no predesigned interventions in this study. | Other | SECRETS-TCM |
Primary outcome
All-cause mortality
Time frame: 12 months follow-up
Composite cerebrovascular and cardiovascular events
Time frame: 12 months follow-up
Including stroke recurrence events,acute myocardial infarction and cardiac death
11 secondary outcomes
All-cause mortality
Time frame: 24 months follow-up
Composite cerebrovascular and cardiovascular events
Time frame: 24 months follow-up
Modified Rankin Scale(mRS)
Time frame: 3 months follow-up
Barthel Index(BI)
Time frame: 3 months follow-up
Mini-Mental State Examination(MMSE)
Time frame: 3 months follow-up
Modified Rankin Scale(mRS)
Time frame: 12 months follow-up
Barthel Index(BI)
Time frame: 12 months follow-up
Mini-Mental State Examination(MMSE)
Time frame: 12 months follow-up
Modified Rankin Scale(mRS)
Time frame: 24 months follow-up
Barthel Index(BI)
Time frame: 24 months follow-up
Mini-Mental State Examination(MMSE)
Time frame: 24 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Yefeng Cai, M.D.,Ph D principal investigator
Guangdong Provincial Hospital of Traditional Chinese Medicine
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 Stroke and Cerebral Infarction, run by Yefeng Cai 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 3 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 8 Mar 2018. 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 Yefeng Cai, M.D.,PhD (+86-13631333842, caiyefeng@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 12 months follow-up). 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 8 Mar 2018.