ST Segment Elevation Myocardial InfarctionNCT01716884
China STEMI-PCI Program
An observational study of ST Segment Elevation Myocardial Infarction, run by Peking University First Hospital at 1 site in China.
Trial summary
1. Registration 2. Performing in three stages 3. Major aim: Much more and standard reperfusion therapy in STEMI patients Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ST Segment Elevation Myocardial Infarction
- How many people
- 4,000 participants
- Where
- 1 siteChina
- Study dates
- Dec 2011to Jun 2016
- 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 enrolled and followed up 1 year
Who may be able to join
- Onset of STEMI within 12h
- Onset of STEMI within 12-36h needing primary PCI
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Division of Cardiology, Peking University First Hospital
Beijing, 100034
Yong Huo, MD
About this study
- Registration
- Performing in three stages
- Major aim: Much more and standard reperfusion therapy in STEMI patients
- Keywords
- STEMI, reperfution, primary PCI
- Medical subject headings
- ST Elevation Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
The reperfusion ratio
Measured: up to 1 day
Secondary outcomes (3)
Door to Balloon time
Measured: up to 1 day
BMS ratio
Measured: up to 1 day
health economic evaluation
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2015 (estimated)
- Study completionJun 2016 (estimated)
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
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices, Sanofi
- Responsible party
- Principal investigator, Yong Huo, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716884
- Sponsor's protocol ID
- 2011[436]
- Status last verified
- Oct 2012
- First submitted
- 26 Oct 2012
- Last updated
- 30 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China STEMI-PCI Program
- ClinicalTrials.gov ID
- NCT01716884
- Acronym / sponsor ID
- 2011[436]
- Keywords
- STEMI, reperfution, primary PCI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Abbott Medical Devices, Sanofi
- Study start
- Dec 2011
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 30 Oct 2012 (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.
- Registration
- Performing in three stages
- Major aim: Much more and standard reperfusion therapy in STEMI patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- STEMI Patients enrolled and followed up 1 year
Key inclusion criteria (2 listed)
- Onset of STEMI within 12h
- Onset of STEMI within 12-36h needing primary PCI
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.
Primary outcome
The reperfusion ratio
Time frame: up to 1 day
3 secondary outcomes
Door to Balloon time
Time frame: up to 1 day
BMS ratio
Time frame: up to 1 day
health economic evaluation
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2012.
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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 ST Segment Elevation Myocardial Infarction, run by Peking University First 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 30 Oct 2012. 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 Yan Zhang, MD (8610-83575180, drzhy1108@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The reperfusion ratio (time frame: up to 1 day). 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 30 Oct 2012.