ACS - Acute Coronary SyndromeNCT03707496
A Registry of De Winter Symdrome of Single Center
An observational study of ACS - Acute Coronary Syndrome, run by Hainan People's Hospital at 1 site in China.
Trial summary
This registry started January 1,2018 to collect patients who diagnosed as De Winter Symdrome for the first time in Hainan General Hospital.All enrolled patients will receive 30 days followed-up. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- ACS - Acute Coronary Syndrome
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2021
- How long will I take part?
- 30 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All acute coronary syndrome patients with a de Winter syndrome ECG pattern
Who may be able to join
- Index ECG ST segment showed a 1- to 3-mm upsloping ST-segment depression at the J point in leads V1 to V6 that continued into tall, positive symmetrical T waves
- Received coronary angiography during hospitalization
Who cannot join
- -No coronary angiography results was available during hospitalization
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hainan General Hospital
Haikou, Hainan, 570311
Wang Liao, MD, 8613518827831, crain_lw@163.com
About this study
Official title: A Registry of De Winter Symdrome of Hainan General Hospital
This registry started January 1,2018 to collect patients who diagnosed as De Winter Symdrome for the first time in Hainan General Hospital.All enrolled patients will receive 30 days followed-up.
- Conditions
- ACS - Acute Coronary Syndrome
- Keywords
- De Winter Syndrome
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DeWinterCohort | Patients with de Winter syndrome pattern ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with MACEs within 30 days
Number of participants with cardiac death,non-fatal myocardial infarction,stroke,heart failure in 30 days
Measured: 30 days
Secondary outcomes (2)
Number of participants with MACEs In-hospital
Number of participants with cardiac death,non-fatal myocardial infarction,stroke,heart failure in-hospital
Measured: throughout current hospitalization
Number of Participants with MACEs within 7 days after admitted
Number of participants with cardiac death,non-fatal myocardial infarction,stroke,heart failure in 7 days
Measured: 7 days after admitted
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start1 Jan 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACS - Acute Coronary SyndromeStudies 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
- 30 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Hainan People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liao Wang, Hainan People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03707496
- Sponsor's protocol ID
- Reg001
- Status last verified
- Apr 2021
- First submitted
- 8 Oct 2018
- Last updated
- 13 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry of De Winter Symdrome of Hainan General Hospital
- ClinicalTrials.gov ID
- NCT03707496
- Acronym / sponsor ID
- Reg001
- Conditions
- ACS - Acute Coronary Syndrome
- Keywords
- De Winter Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hainan People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 16 Oct 2018 (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.
This registry started January 1,2018 to collect patients who diagnosed as De Winter Symdrome for the first time in Hainan General Hospital.All enrolled patients will receive 30 days followed-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DeWinterCohort | – | –Patients with de Winter syndrome pattern ECG |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All acute coronary syndrome patients with a de Winter syndrome ECG pattern
Key inclusion criteria (2 listed)
- Index ECG ST segment showed a 1- to 3-mm upsloping ST-segment depression at the J point in leads V1 to V6 that continued into tall, positive symmetrical T waves
- Received coronary angiography during hospitalization
Key exclusion criteria (1 listed)
- -No coronary angiography results was available during hospitalization
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
Number of Participants with MACEs within 30 days
Time frame: 30 days
Number of participants with cardiac death,non-fatal myocardial infarction,stroke,heart failure in 30 days
2 secondary outcomes
Number of participants with MACEs In-hospital
Time frame: throughout current hospitalization
Number of Participants with MACEs within 7 days after admitted
Time frame: 7 days after admitted
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
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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 ACS - Acute Coronary Syndrome, run by Hainan People's 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 2 inclusion and 1 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 Apr 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 Wang Liao, MD (13518827831, crain_lw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with MACEs within 30 days (time frame: 30 days). 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 Apr 2021.