ST-segment Elevation Myocardial InfarctionREDUCTIONNCT03763968
Multicentre REtrospective StuDy of Treatment and OUtComes in STEMI Patients in Fujian Province
An observational study of ST-segment Elevation Myocardial Infarction, run by Yan-song Guo at 1 site in China.
Trial summary
This is a multicentre observational study planned to gather follow up data for a period of 1 year in order to understand the treatments and outcomes of ST-segment elevation myocardial infarction(STEMI) and improve medical care quality in Fujian province for China. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ST-segment Elevation Myocardial Infarction
- What is being tested?
- treatment and outcome
- How many people
- 7,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2014to 31 Dec 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: STEMI patients with symptom onset within 30 days
Who may be able to join
- STEMI patients with symptom onset within 30 days
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentre REtrospective StuDy of Treatment and OUtComes in ST-elevatION Myocardial Infarction(STEMI) Patients in Fujian Province
This is a multicentre observational study planned to gather follow up data for a period of 1 year in order to understand the treatments and outcomes of ST-segment elevation myocardial infarction(STEMI) and improve medical care quality in Fujian province for China. Consecutive patients who were admitted and diagnosed with STEMI between January 2014 December 2018 were conducted at five regional representative hospitals in Fujian province, which included the Fujian Provincial Hospital,Longyan First Hospital, the affiliated hospital of putian university,the Second Affiliated Hospital of Fujian Medical University and Mindong Hospital of Ningde City.
- Being tested
- treatment and outcome
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment and outcomeOther
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
all mortality,cardiovascular mortality
Measured: 5years
Secondary outcomes (2)
other in-hospital complications
recurrent myocardial infarction, target vessel revascularization,contrast-induced acute kidney injury,stroke,bleeding,and so on
Measured: 5years
MACEs for long-term follow up
mortality,stent restenosis, recurrent myocardial infarction, and target vessel revascularization,stroke,bleeding,and so on
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start1 Jan 2014
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-segment Elevation Myocardial InfarctionStudies 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
- Retrospective
- Enrolment
- 7,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yan-song Guo
- Sponsor type
- University, hospital or other
- Collaborators
- Longyan City First Hospital, The Affiliated Hospital of Putian University, The Second Affiliated Hospital of Fujian Medical University, The MinDong Hospital of Ningde City
- Responsible party
- Sponsor-investigator, Yan-song Guo, Fujian Provincial Hospital
- Investigators
- Kai-yang Lin, Doctor, Principal investigator, Fujian Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763968
- Sponsor's protocol ID
- YGuo
- Acronym
- REDUCTION
- Status last verified
- Jan 2019
- First submitted
- 30 Nov 2018
- Last updated
- 3 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre REtrospective StuDy of Treatment and OUtComes in ST-elevatION Myocardial Infarction(STEMI) Patients in Fujian Province
- ClinicalTrials.gov ID
- NCT03763968
- Acronym / sponsor ID
- REDUCTION / YGuo
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,000 participants (actual)
- Lead sponsor
- Yan-song GuoUniversity, hospital or other
- Collaborators
- Longyan City First Hospital, The Affiliated Hospital of Putian University, The Second Affiliated Hospital of Fujian Medical University, The MinDong Hospital of Ningde City
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 4 Dec 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 is a multicentre observational study planned to gather follow up data for a period of 1 year in order to understand the treatments and outcomes of ST-segment elevation myocardial infarction(STEMI) and improve medical care quality in Fujian province for China. Consecutive patients who were admitted and diagnosed with STEMI between January 2014 December 2018 were conducted at five regional representative hospitals in Fujian province, which included the Fujian Provincial Hospital,Longyan First Hospital, the affiliated hospital of putian university,the Second Affiliated Hospital of Fujian Medical University and Mindong Hospital of Ningde City.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- STEMI patients with symptom onset within 30 days
Key inclusion criteria (1 listed)
- STEMI patients with symptom onset within 30 days
Key exclusion criteria (1 listed)
- -
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 and outcome | Other | – |
Primary outcome
In-hospital mortality
Time frame: 5years
all mortality,cardiovascular mortality
2 secondary outcomes
other in-hospital complications
Time frame: 5years
MACEs for long-term follow up
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- 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.
Kai-yang Lin, Doctor principal investigator
Fujian Provincial 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 ST-segment Elevation Myocardial Infarction, run by Yan-song Guo 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 1 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: finished, as of the sponsor's last update on 3 Jan 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: 5years). 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 3 Jan 2019.