Coronary Artery DiseaseNCT02641184
Evaluation of Novel Risk Factors and Clinical Outcomes of Acute Myocardial Infarction
An observational study of Coronary Artery Disease and Percutaneous Coronary Intervention, run by Zhejiang Provincial People's Hospital at 1 site in China.
Trial summary
The aim of this study is to investigate the potential novel risk factors for acute myocardial infarction. Predictors of poor outcomes will be also evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Percutaneous Coronary Intervention, Acute Myocardial Infarction
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Dec 2017
- 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 presenting to an emergency room and diagnosed as acute myocardial infarction
Who may be able to join
- Less than 12 hours after the onset of myocardial infarction symptoms
- Myocardial necrosis, as evidenced by increased Creatine Kinase Isoenzyme (CK-MB) or troponin levels
Who cannot join
- Age under 18 years-old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Prospective Observational Study to Evaluate the Novel Risk Factors and Clinical Outcomes of Acute Myocardial Infarction (AMI)
The aim of this study is to investigate the potential novel risk factors for acute myocardial infarction. Predictors of poor outcomes will be also evaluated.
- Keywords
- Myocardial Infarction, Cardiovascular Diseases, Heart Diseases, Infarction, Diabetes
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction, Cardiovascular Diseases, Heart Diseases, Infarction, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events (MACE)
Composite of angina pectoris, reinfarction, unplanned rehospitalization, stent thrombosis, incidence of cardiac death in the duration of follow-up
Measured: maximum 5 years
Secondary outcomes (2)
Length of hospital stay
The length of in-hospital stay is counted as a secondary outcome
Measured: in the phase of hospital stay, maximum 30 days
New-onset diabetes
New-onset diabetes are defined as newly-diagnosed type 2 diabetes mellitus
Measured: the duration of follow-up, maximum 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Yangzhou No.1 People's Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Huai'an First People's Hospital
- Responsible party
- Principal investigator, Xiao Ye, MD, Zhejiang Provincial People's Hospital
- Investigators
- Baiming Qu, MD, Principal investigator, Department of Cardiology, Zhejiang Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641184
- Sponsor's protocol ID
- ZJPPH01
- Status last verified
- Feb 2016
- First submitted
- 14 Dec 2015
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Observational Study to Evaluate the Novel Risk Factors and Clinical Outcomes of Acute Myocardial Infarction (AMI)
- ClinicalTrials.gov ID
- NCT02641184
- Acronym / sponsor ID
- ZJPPH01
- Keywords
- Myocardial Infarction, Cardiovascular Diseases, Heart Diseases, Infarction, Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Yangzhou No.1 People's Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Huai'an First People's Hospital
- Study start
- Dec 2015
- Primary completion
- Dec 2017 (estimated)
- First posted
- 29 Dec 2015 (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.
The aim of this study is to investigate the potential novel risk factors for acute myocardial infarction. Predictors of poor outcomes will be also evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to an emergency room and diagnosed as acute myocardial infarction
Key inclusion criteria (2 listed)
- Less than 12 hours after the onset of myocardial infarction symptoms
- Myocardial necrosis, as evidenced by increased Creatine Kinase Isoenzyme (CK-MB) or troponin levels
Key exclusion criteria (1 listed)
- Age under 18 years-old
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
Major adverse cardiovascular events (MACE)
Time frame: maximum 5 years
Composite of angina pectoris, reinfarction, unplanned rehospitalization, stent thrombosis, incidence of cardiac death in the duration of follow-up
2 secondary outcomes
Length of hospital stay
Time frame: in the phase of hospital stay, maximum 30 days
New-onset diabetes
Time frame: the duration of follow-up, maximum 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
- Individual participant dataSharing planned: No. No plan to share data
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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.
Baiming Qu, MD principal investigator
Department of Cardiology, Zhejiang Provincial People's 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 Coronary Artery Disease and Percutaneous Coronary Intervention, run by Zhejiang Provincial 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 17 Feb 2016. 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?
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?
Major adverse cardiovascular events (MACE) (time frame: maximum 5 years). 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 17 Feb 2016; AzTrials last refreshed its copy on 8 Nov 2026.