Atrial FibrillationCRISTNCT02156765
China Atrial Fibrillation Screening in Acute Ischemic Stroke Patients
An observational study of Atrial Fibrillation and Stroke, run by yongjun wang at 1 site in China.
Trial summary
Three purpose of this study: 1. Increase diagnosis rate and formulate the flow of diagnosis and treatment of AF in ischemic stroke patients; 2. Evaluation on specificity and sensitivity of STAF score; 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Stroke
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Mar 2015
- How long will I take part?
- 6 Days
- 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: Hospitalized patients with ischemic stroke that are diagnosed definitely
Who may be able to join
- Hospitalized patients with ischemic stroke that are diagnosed definitely;
- Age ≥ 18 years;
- Within 7 days after the onset of diseases;
- Signed the consent informed form.
Who cannot join
- Patients with noncerebrovascular diseases that are diagnosed definitely;
- Silent cerebral infarction (CI) without symptoms and signs;
- Those refuse to sign the consent informed form of the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Stroke Association
Beijing, Beijing Municipality, 100050
yongjun wang, doctoe, 13911172565, yongjunwang1962@gmail.com
About this study
Three purpose of this study:
- Increase diagnosis rate and formulate the flow of diagnosis and treatment of AF in ischemic stroke patients;
- Evaluation on specificity and sensitivity of STAF score;
- Analyze the pathogenesis of ischemic stroke and risk factors and establish clinical database and sample database of ischemic stroke.
Read the detailed description
Inclusion criteria:
- Hospitalized patients with ischemic stroke that are diagnosed definitely;
- Age ≥ 18 years;
- Within 7 days after the onset of diseases;
- Signed the consent informed form.
Exclusion criteria:
- Patients with noncerebrovascular diseases that are diagnosed definitely;
- Silent cerebral infarction (CI) without symptoms and signs;
- Those refuse to sign the consent informed form of the study.
- Conditions
- Atrial Fibrillation, Stroke
- Keywords
- Atrial Fibrillation, Screening, Stroke patients
- Medical subject headings
- Atrial Fibrillation, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Accumulated detection rate of AF
ECG was monitored for all patients enrolled in a single center for consecutive 6 days
Measured: 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startOct 2013
- Primary completionMar 2015 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 6 Days
Sponsor and investigators
- Lead sponsor
- yongjun wang
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, yongjun wang, Ministry of Science and Technology of the People´s Republic of China
- Investigators
- yongjun wang, doctor, Principal investigator, Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156765
- Sponsor's protocol ID
- TTYY-20140410
- Acronym
- CRIST
- Status last verified
- Jun 2014
- First submitted
- 3 Jun 2014
- Last updated
- 5 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ay H, Furie KL, Singhal A, Smith WS, Sorensen AG, Koroshetz WJ. An evidence-based causative classification system for acute ischemic stroke. Ann Neurol. 2005 Nov;58(5):688-97. doi: 10.1002/ana.20617.
PubMed 16240340Li SY, Yang XM, Zhao XQ, Liu LP, Wang YL, Jiang Y, Wang YJ. Newly detected atrial fibrillation is associated with cortex-involved ischemic stroke. Chin Med J (Engl). 2019 Sep 5;132(17):2053-2058. doi: 10.1097/CM9.0000000000000390.
PubMed 31403970Yang X, Li S, Zhao X, Liu L, Jiang Y, Li Z, Wang Y, Wang Y. Atrial fibrillation is not uncommon among patients with ischemic stroke and transient ischemic stroke in China. BMC Neurol. 2017 Dec 4;17(1):207. doi: 10.1186/s12883-017-0987-y.
PubMed 29202727
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Atrial Fibrillation Screening in Acute Ischemic Stroke Patients
- ClinicalTrials.gov ID
- NCT02156765
- Acronym / sponsor ID
- CRIST / TTYY-20140410
- Conditions
- Atrial Fibrillation, Stroke
- Keywords
- Atrial Fibrillation, Screening, Stroke patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- yongjun wangOther government
- Study start
- Oct 2013
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 5 Jun 2014 (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.
Three purpose of this study:
- Increase diagnosis rate and formulate the flow of diagnosis and treatment of AF in ischemic stroke patients;
- Evaluation on specificity and sensitivity of STAF score;
- Analyze the pathogenesis of ischemic stroke and risk factors and establish clinical database and sample database of ischemic stroke.
Detailed description
Inclusion criteria:
- Hospitalized patients with ischemic stroke that are diagnosed definitely;
- Age ≥ 18 years;
- Within 7 days after the onset of diseases;
- Signed the consent informed form.
Exclusion criteria:
- Patients with noncerebrovascular diseases that are diagnosed definitely;
- Silent cerebral infarction (CI) without symptoms and signs;
- Those refuse to sign the consent informed form of the study.
Study design
- Time perspective
- Prospective
- Target follow-up
- 6 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients with ischemic stroke that are diagnosed definitely
Key inclusion criteria (4 listed)
- Hospitalized patients with ischemic stroke that are diagnosed definitely;
- Age ≥ 18 years;
- Within 7 days after the onset of diseases;
- Signed the consent informed form.
Key exclusion criteria (3 listed)
- Patients with noncerebrovascular diseases that are diagnosed definitely;
- Silent cerebral infarction (CI) without symptoms and signs;
- Those refuse to sign the consent informed form of the study.
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
Accumulated detection rate of AF
Time frame: 1.5 year
ECG was monitored for all patients enrolled in a single center for consecutive 6 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2014.
- Background: PubMed 16240340Ay H, Furie KL, Singhal A, Smith WS, Sorensen AG, Koroshetz WJ. An evidence-based causative classification system for acute ischemic stroke. Ann Neurol. 2005 Nov;58(5):688-97. doi: 10.1002/ana.20617.
- Derived from this study: PubMed 31403970Li SY, Yang XM, Zhao XQ, Liu LP, Wang YL, Jiang Y, Wang YJ. Newly detected atrial fibrillation is associated with cortex-involved ischemic stroke. Chin Med J (Engl). 2019 Sep 5;132(17):2053-2058. doi: 10.1097/CM9.0000000000000390.
- Derived from this study: PubMed 29202727Yang X, Li S, Zhao X, Liu L, Jiang Y, Li Z, Wang Y, Wang Y. Atrial fibrillation is not uncommon among patients with ischemic stroke and transient ischemic stroke in China. BMC Neurol. 2017 Dec 4;17(1):207. doi: 10.1186/s12883-017-0987-y.
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Atrial Fibrillation (AF)
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.
yongjun wang, doctor principal investigator
Tiantan 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 Atrial Fibrillation and Stroke, run by yongjun wang 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 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 5 Jun 2014. 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 yongjun wang, doctor (13911172565, yongjunwang1962@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accumulated detection rate of AF (time frame: 1.5 year). 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 NCT02156765, which also lists 3 linked publications.
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 5 Jun 2014.