Ischemic StrokeCASES-TCMNCT04921397
China Stroke Registry for Patients With Traditional Chinese Medicine
An observational study of Ischemic Stroke and Intracerebral Hemorrhage, run by Dongzhimen Hospital, Beijing at 1 site in China.
Trial summary
The CASES-TCM study is a prospective, multicenter, observational study, which will enroll 20,000 patients with acute stroke (ischemic stroke or intracerebral hemorrhage) within 7 days of symptom onset. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Intracerebral Hemorrhage
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- 11 Jun 2021to 1 Jun 2025
- 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: Patients who meet the criteria will be consecutively enrolled from 100 participating sites in China.
Who may be able to join
- ≥18 years of age
- Diagnosed as acute ischemic stroke or intracerebral hemorrhage
- Within 7 days of symptom onset
Who cannot join
- Refusal to give informed consent
- Have difficulties completing follow-up
Trial locations and contacts
1 site in 1 country.
China1 site
Dongzhimen Hospital
Beijing, Beijing Municipality, 100700
Ying Gao, gaoying973@163.com
About this study
Official title: China Stroke Registry for Patients With Traditional Chinese Medicine (CASES-TCM): A Prospective, Multicenter, Observational Study
The CASES-TCM study is a prospective, multicenter, observational study, which will enroll 20,000 patients with acute stroke (ischemic stroke or intracerebral hemorrhage) within 7 days of symptom onset.
This study attempts to depict major clinical characteristics of acute stroke in patients with Chinese medicine treatment and to explore any difference compared with other non-Chinese medicine use cohorts and the effectiveness and safety of Chinese medicine.
- Conditions
- Ischemic Stroke, Intracerebral Hemorrhage
- Medical subject headings
- Ischemic Stroke, Cerebral Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of scores on the modified Rankin scale at 3-month follow-up
Modified Rankin Scale, a commonly used scale for measuring the degree of dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. 0 - No symptoms.1 -No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.3 - Moderate disability. Requires some help, but able to walk unassisted.4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.6 - Dead.
Measured: 3 months follow-up
Recurrent stroke events (ischemic stroke, hemorrhagic stroke including intracerebral hemorrhage and subarachnoid hemorrhage) within 12-month follow-up
Number of patients with new ischemic stroke and hemorrhagic stroke within 12 months of follow-up.
Measured: 12 months follow-up
Secondary outcomes (12)
Proportion of patients receive Chinese medicine treatment within 24 hours after admission
Chinese medicine treatment exposure defined as whether patients receive Chinese medicine injection, oral Chinese patent medicine, or compound Chinese medicine.
Measured: 24 hours after admission
Chinese medicine treatment duration within 3-month, 12-month, and 24-month follow-up
Chinese medicine treatment duration will be assessed using proportion of days covered, which is a percentage of days covered with the medicine in the number of days the patient is eligible to have the medication.
Measured: 3 months, 12 months, and 24 months follow-up
Change in the National Institutes of Health Stroke Scale score between baseline (admission) and discharge
National Institute of Health Stroke Scale is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. It is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
Measured: At admission (baseline) and discharge (14 days - mean for length of hospitalization for stroke patients)
Patient-Reported Outcomes Scale for Stroke score at discharge
Patient-Reported Outcomes Scale for Stroke, a structured questionnaire-scale was developed suitable for Chinese patients. The score ranges from 0 (best) to 144 (worst).
Measured: At discharge (14 days - mean for length of hospitalization for stroke patients)
Proportion of patients with modified Rankin Scale score ≤2 at 3-month and 12-month follow-up
Modified Rankin Scale, a commonly used scale for measuring the degree of dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. 0 - No symptoms.1 -No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.3 - Moderate disability. Requires some help, but able to walk unassisted.4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.6 - Dead.
Measured: 3 months, 12 months follow-up
Distribution of scores on the modified Rankin scale at 12-month follow-up
Modified Rankin Scale, a commonly used scale for measuring the degree of dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. 0 - No symptoms.1 -No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.3 - Moderate disability. Requires some help, but able to walk unassisted.4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.6 - Dead.
Measured: 12 months follow-up
Proportion of patients with Barthel Index score ≥90 at 3-month and 12-month follow-up
Barthel Index is a commonly used scale for measuring the activity of daily living of people. Score of 10-item scale ranges from 0 (worst) to 100 (best).
Measured: 3 months, 12 months follow-up
Recurrent stroke events (ischemic stroke, hemorrhagic stroke including intracerebral hemorrhage and subarachnoid hemorrhage) within 3-month and 24-month follow-up
Number of patients with new ischemic stroke and hemorrhagic stroke events within 3 months and 24 months of follow-up.
Measured: 3 months, 24 months follow-up
Composite of new clinical vascular events within 3-month, 12-month, and 24-month follow-up
Number of patients with new clinical vascular events (ischemic stroke/ hemorrhagic stroke/ transient ischemic attack / myocardial infarction /vascular death) within 3 months, 12 months, and 24 months of follow-up.
Measured: 3 months, 12 months, 24 months follow-up
Mini-Mental State Examination scale score at 3-month, 12-month, and 24-month follow-up
Mini-Mental State Examination scale is a commonly used scale for measuring the cognitive function. Range: 0 to 30 points, higher points represent a better outcome.
Measured: 3 months, 12 months, 24 months follow-up
All-cause mortality within 12-month and 24-month follow-up
Number of patients who died within 12 months and 24 months of follow-up.
Measured: 12 months, 24 months follow-up
Incidence of adverse events
Number of patients with any adverse events (including serious adverse events) during the study.
Measured: Up to 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 posted10 Jun 2021
- Study start11 Jun 2021 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Gao, Dongzhimen Hospital, Beijing
- Investigators
- Ying Gao, Principal investigator, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921397
- Sponsor's protocol ID
- 2021XS-001
- Acronym
- CASES-TCM
- Status last verified
- Jun 2021
- First submitted
- 1 Jun 2021
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feng L, Kong L, Dong X, Lai X, Zhang D, Ren B, Liu S, Xie X, Li C, Song Y, Du Y, Cao K, Zhang C, Gao Y; CASES-TCM Protocol Steering Group. China Stroke Registry for Patients With Traditional Chinese Medicine (CASES-TCM): Rationale and Design of a Prospective, Multicenter, Observational Study. Front Pharmacol. 2021 Aug 31;12:743883. doi: 10.3389/fphar.2021.743883. eCollection 2021.
PubMed 34531755
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Stroke Registry for Patients With Traditional Chinese Medicine (CASES-TCM): A Prospective, Multicenter, Observational Study
- ClinicalTrials.gov ID
- NCT04921397
- Acronym / sponsor ID
- CASES-TCM / 2021XS-001
- Conditions
- Ischemic Stroke, Intracerebral Hemorrhage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Study start
- 11 Jun 2021 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 10 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 CASES-TCM study is a prospective, multicenter, observational study, which will enroll 20,000 patients with acute stroke (ischemic stroke or intracerebral hemorrhage) within 7 days of symptom onset.
This study attempts to depict major clinical characteristics of acute stroke in patients with Chinese medicine treatment and to explore any difference compared with other non-Chinese medicine use cohorts and the effectiveness and safety of Chinese medicine.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who meet the criteria will be consecutively enrolled from 100 participating sites in China.
Key inclusion criteria (3 listed)
- ≥18 years of age
- Diagnosed as acute ischemic stroke or intracerebral hemorrhage
- Within 7 days of symptom onset
Key exclusion criteria (2 listed)
- Refusal to give informed consent
- Have difficulties completing follow-up
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
Distribution of scores on the modified Rankin scale at 3-month follow-up
Time frame: 3 months follow-up
Modified Rankin Scale, a commonly used scale for measuring the degree of dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. 0 - No symptoms.1 -No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.3 - Moderate disability. Requires some help, but able to walk unassisted.4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.6 - Dead.
Recurrent stroke events (ischemic stroke, hemorrhagic stroke including intracerebral hemorrhage and subarachnoid hemorrhage) within 12-month follow-up
Time frame: 12 months follow-up
Number of patients with new ischemic stroke and hemorrhagic stroke within 12 months of follow-up.
12 secondary outcomes
Proportion of patients receive Chinese medicine treatment within 24 hours after admission
Time frame: 24 hours after admission
Chinese medicine treatment duration within 3-month, 12-month, and 24-month follow-up
Time frame: 3 months, 12 months, and 24 months follow-up
Change in the National Institutes of Health Stroke Scale score between baseline (admission) and discharge
Time frame: At admission (baseline) and discharge (14 days - mean for length of hospitalization for stroke patients)
Patient-Reported Outcomes Scale for Stroke score at discharge
Time frame: At discharge (14 days - mean for length of hospitalization for stroke patients)
Proportion of patients with modified Rankin Scale score ≤2 at 3-month and 12-month follow-up
Time frame: 3 months, 12 months follow-up
Distribution of scores on the modified Rankin scale at 12-month follow-up
Time frame: 12 months follow-up
Proportion of patients with Barthel Index score ≥90 at 3-month and 12-month follow-up
Time frame: 3 months, 12 months follow-up
Recurrent stroke events (ischemic stroke, hemorrhagic stroke including intracerebral hemorrhage and subarachnoid hemorrhage) within 3-month and 24-month follow-up
Time frame: 3 months, 24 months follow-up
Composite of new clinical vascular events within 3-month, 12-month, and 24-month follow-up
Time frame: 3 months, 12 months, 24 months follow-up
Mini-Mental State Examination scale score at 3-month, 12-month, and 24-month follow-up
Time frame: 3 months, 12 months, 24 months follow-up
All-cause mortality within 12-month and 24-month follow-up
Time frame: 12 months, 24 months follow-up
Incidence of adverse events
Time frame: Up to 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 10 Jun 2021.
- Derived from this study: PubMed 34531755Feng L, Kong L, Dong X, Lai X, Zhang D, Ren B, Liu S, Xie X, Li C, Song Y, Du Y, Cao K, Zhang C, Gao Y; CASES-TCM Protocol Steering Group. China Stroke Registry for Patients With Traditional Chinese Medicine (CASES-TCM): Rationale and Design of a Prospective, Multicenter, Observational Study. Front Pharmacol. 2021 Aug 31;12:743883. doi: 10.3389/fphar.2021.743883. eCollection 2021.
- 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.
Ying Gao principal investigator
Dongzhimen Hospital, Beijing
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 and Intracerebral Hemorrhage, run by Dongzhimen Hospital, Beijing 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 10 Jun 2021. 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 Ying Gao (+86-10-84013209, gaoying973@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of scores on the modified Rankin scale at 3-month follow-up (time frame: 3 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?
On the ClinicalTrials.gov record for NCT04921397, which also lists 1 linked publication.
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 10 Jun 2021.