Coronary Artery DiseasePCI-registryNCT02498470
Prospective Registry to Assess the Cath Lab Percutaneous Coronary Intervention Long-term Outcomes: a Single Center
An observational study of Coronary Artery Disease, run by Xiao-dong Zhuang at 1 site in China.
Trial summary
The registry study is to obtain the state of the percutaneous coronary intervention state treatment for coronary heart disease in the center of the first hospital of sun yat-sen unversity in a real world. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2008to Dec 2017
- How long will I take part?
- 5 Years
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All the patients receiving coronal artery angiography or percutaneous coronary intervention therapy in the first affiliated hospital of sun yat-sen university
Who may be able to join
- Patients receiving coronal artery angiography or percutaneous coronary intervention therapy
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiaodong Zhaung
Guangzhou, Guangdong, 510080
xiaodong zhuang, MD,PhD, +8602087332200, zxd_medicine@163.com
zhxd2@mail2.sysu.edu.cn
About this study
The registry study is to obtain the state of the percutaneous coronary intervention state treatment for coronary heart disease in the center of the first hospital of sun yat-sen unversity in a real world.
Read the detailed description
The registry study is to obtain the long-term outcomes of the percutaneous coronary intervention state treatment for coronary heart disease patients in the center of the first hospital of sun yat-sen unversity in a real world. The data are collected using an uploading system through internet.
- Conditions
- Coronary Artery Disease
- Being tested
- percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous coronary interventionProcedure or surgery
All the patients receiving coronal artery angiography or percutaneous coronary intervention therapy by standard protocol
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Major Adverse Cardiac Events (MACE)
All death All death, myocardial infarction, revascularization
Measured: 5 years
Secondary outcomes (1)
Target Lesion Failure
composite target lesion failure (TLF) defined as a composite of cardiac death, non-fatal myocardial infarction (MI) not clearly attributable to a nontarget vessel, or target lesion revascularization (TLR) (percutaneous or by coronary artery bypass grafting)
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startJan 2008
- Primary completionDec 2017 (estimated)
- Study 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
- 10,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Xiao-dong Zhuang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiao-dong Zhuang, Sun Yat-sen University
- Investigators
- zhimin du, MD, Principal investigator, first affiliated hospital of sun yat-sen university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498470
- Sponsor's protocol ID
- PCI-registry
- Acronym
- PCI-registry
- Status last verified
- Apr 2016
- First submitted
- 12 Jul 2015
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry to Assess the Cath Lab Percutaneous Coronary Intervention Long-term Outcomes: a Single Center
- ClinicalTrials.gov ID
- NCT02498470
- Acronym / sponsor ID
- PCI-registry / PCI-registry
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Xiao-dong ZhuangUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 15 Jul 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 registry study is to obtain the state of the percutaneous coronary intervention state treatment for coronary heart disease in the center of the first hospital of sun yat-sen unversity in a real world.
Detailed description
The registry study is to obtain the long-term outcomes of the percutaneous coronary intervention state treatment for coronary heart disease patients in the center of the first hospital of sun yat-sen unversity in a real world. The data are collected using an uploading system through internet.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients receiving coronal artery angiography or percutaneous coronary intervention therapy in the first affiliated hospital of sun yat-sen university
Key inclusion criteria (1 listed)
- Patients receiving coronal artery angiography or percutaneous coronary intervention therapy
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| percutaneous coronary interventionAll the patients receiving coronal artery angiography or percutaneous coronary intervention therapy by standard protocol | Procedure or surgery | – |
Primary outcome
Composite Major Adverse Cardiac Events (MACE)
Time frame: 5 years
All death All death, myocardial infarction, revascularization
1 secondary outcome
Target Lesion Failure
Time frame: 5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
- 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.
zhimin du, MD principal investigator
first affiliated hospital of sun yat-sen university
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, run by Xiao-dong Zhuang 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: status not confirmed, as of the sponsor's last update on 13 Apr 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?
Contact xiaodong zhuang, MD,PhD (+8602087332200, zxd_medicine@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Major Adverse Cardiac Events (MACE) (time frame: 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 13 Apr 2016.