Coronary Heart DiseaseP-PUSHNCT02667548
Prospective Evaluation of Prognosis of Pci Patients Using Network Data in SHengjing Hospital
An observational study of Coronary Heart Disease, run by Shengjing Hospital.
Trial summary
Coronary heart disease (CHD) has a serious health threaten to population. PCI is a well-proved measure in CHD management. However, the knowledge about the real-life PCI use and how evidence-based therapies in routine clinical practice is limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- PCI
- Type of treatment
- Surgery or procedure
- How many people
- 7,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jan 2021
- 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: In department of Cardiology,Shengjing Hospital of China Medical University, 7000 hospitalized patients undergoing Percutaneous Coronary Intervention will be enrolled consecutively.
Who may be able to join
- Hospitalized patients undergoing a percutaneous coronary intervention (PCI) for coronary lesions.
Who cannot join
- Previously enrolled in the R-PUSH study
About this study
Official title: Prospective Evaluation of Prognosis of Pci Patients Using Network Data in SHengjing Hospital of China Medical University
Coronary heart disease (CHD) has a serious health threaten to population. PCI is a well-proved measure in CHD management. However, the knowledge about the real-life PCI use and how evidence-based therapies in routine clinical practice is limited. By consecutively recruiting PCI patients in a large-scale hospital in in Northeast China,this study will examine various real-life factors, that may affect patients recovery after the procedure. Practical guidelines, appropriateness criteria and quality evaluative system for PCI will be established based on the findings, to improve patients outcomes in future finally.
Read the detailed description
Cardiovascular disease (CVD) is a major concern in public health in China. Relatively limited information is available about how evidence-based therapies are incorporated appropriately into routine clinical practice. Practical and applied knowledge from large unselected population is needed to guide practice for quality improvement.
This study will enroll patients undergoing PCI in a large-scale hospital in in Northeast China. At study entry, participants will be interviewed during their index hospitalization, to collect information about symptoms, functioning, quality of life, and medical care. Demographic characteristics, medical history, clinical features, diagnostic tests, medications, procedures, and in-hospital outcomes of patients will be abstracted from medical records by well trained professional abstractors. CAG imaging will be reviewed by 2 cardiologists through PACS. Other Procedural data, including stent type, total stent length and so on, came from operation records of PCI cases finished by operators. At 1 month, 6 month, 12 month, 3 year and 5 year after discharge, participants will return to the clinic for follow up visits, a face-to-face interview will be conducted to get information about clinical events, symptoms, functioning, quality of life, and medical care during the recovery period. If participants can not return to the clinic for follow up visits,a telephone interview will be conducted to get the related information. Before discharge,, blood sample will be collected. Participants' blood samples will be stored for future biologic and genetic studies. This study will examine various real-life factors that may affect patients recovery after PCI, including patients' characteristics and treatment measures. Practical guidelines, quality evaluative system, and appropriateness criteria will be established based on the findings, to improve patients outcomes in future finally.
- Conditions
- Coronary Heart Disease
- Being tested
- PCI
- Keywords
- percutaneous coronary intervention
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCIProcedure or surgery
percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| patients receiving PCI | patients receiving PCI Receives: Procedure: PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Major adverse cardiovascular events (MACE)
Composite of major adverse cardiovascular events (MACE) including cardiac death, non-fatal AMI, coronary revascularization procedure, or ischemic stroke
Measured: 5 year
Secondary outcomes (12)
Percentage of Participants with all-cause death
Measured: 5 year
Percentage of Participants with cardiac death
Measured: 5 year
Percentage of Participants with non-fatal AMI
Measured: 5 year
Percentage of Participants with coronary revascularization procedure
coronary revascularization procedure includs any unplanned repeat PCI or surgical bypass of target or non-target vessels.
Measured: 5 year
Percentage of Participants with ischemic stroke
Measured: 5 year
Percentage of Participants with Cardiac Re-admission
Cardiac Re-admission includes any re-admission because of aggravation of heart failure or angia.
Measured: 5 year
Percentage of Participants with Adherence to medications for secondary prevention
Taking the following medications for 6 or more days per week: aspirin, clopidogrel, ACEI/ARB, statin and beta-blockers
Measured: 5 year
Number of Participants who quit smoking
Measured: 5 year
Symptoms status as assessed by SAQ
Measured: 5 year
Quality of life as assessed by EQ-5D
Measured: 5 year
Depression as assessed by PHQ-8
Measured: 5 year
Stress as assessed by PSS-4
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 posted29 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YU Tong-tong, Shengjing Hospital
- Investigators
- Tongtong Yu, Doctor, Principal investigator, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667548
- Sponsor's protocol ID
- 2016PS04K02
- Acronym
- P-PUSH
- Status last verified
- Mar 2018
- First submitted
- 21 Jan 2016
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: We will not share IPD to protect our data very well.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Prognosis of Pci Patients Using Network Data in SHengjing Hospital of China Medical University
- ClinicalTrials.gov ID
- NCT02667548
- Acronym / sponsor ID
- P-PUSH / 2016PS04K02
- Conditions
- Coronary Heart Disease
- Keywords
- percutaneous coronary intervention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 29 Jan 2016 (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.
Coronary heart disease (CHD) has a serious health threaten to population. PCI is a well-proved measure in CHD management. However, the knowledge about the real-life PCI use and how evidence-based therapies in routine clinical practice is limited. By consecutively recruiting PCI patients in a large-scale hospital in in Northeast China,this study will examine various real-life factors, that may affect patients recovery after the procedure. Practical guidelines, appropriateness criteria and quality evaluative system for PCI will be established based on the findings, to improve patients outcomes in future finally.
Detailed description
Cardiovascular disease (CVD) is a major concern in public health in China. Relatively limited information is available about how evidence-based therapies are incorporated appropriately into routine clinical practice. Practical and applied knowledge from large unselected population is needed to guide practice for quality improvement.
This study will enroll patients undergoing PCI in a large-scale hospital in in Northeast China. At study entry, participants will be interviewed during their index hospitalization, to collect information about symptoms, functioning, quality of life, and medical care. Demographic characteristics, medical history, clinical features, diagnostic tests, medications, procedures, and in-hospital outcomes of patients will be abstracted from medical records by well trained professional abstractors. CAG imaging will be reviewed by 2 cardiologists through PACS. Other Procedural data, including stent type, total stent length and so on, came from operation records of PCI cases finished by operators. At 1 month, 6 month, 12 month, 3 year and 5 year after discharge, participants will return to the clinic for follow up visits, a face-to-face interview will be conducted to get information about clinical events, symptoms, functioning, quality of life, and medical care during the recovery period. If participants can not return to the clinic for follow up visits,a telephone interview will be conducted to get the related information. Before discharge,, blood sample will be collected. Participants' blood samples will be stored for future biologic and genetic studies. This study will examine various real-life factors that may affect patients recovery after PCI, including patients' characteristics and treatment measures. Practical guidelines, quality evaluative system, and appropriateness criteria will be established based on the findings, to improve patients outcomes in future finally.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients receiving PCI | – | Procedure: PCIpatients receiving PCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In department of Cardiology,Shengjing Hospital of China Medical University, 7000 hospitalized patients undergoing Percutaneous Coronary Intervention will be enrolled consecutively.
Key inclusion criteria (1 listed)
- Hospitalized patients undergoing a percutaneous coronary intervention (PCI) for coronary lesions.
Key exclusion criteria (1 listed)
- Previously enrolled in the R-PUSH study
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 |
|---|---|---|
| PCIpercutaneous coronary intervention | Procedure or surgery | patients receiving PCI |
Primary outcome
Percentage of Participants with Major adverse cardiovascular events (MACE)
Time frame: 5 year
Composite of major adverse cardiovascular events (MACE) including cardiac death, non-fatal AMI, coronary revascularization procedure, or ischemic stroke
12 secondary outcomes
Percentage of Participants with all-cause death
Time frame: 5 year
Percentage of Participants with cardiac death
Time frame: 5 year
Percentage of Participants with non-fatal AMI
Time frame: 5 year
Percentage of Participants with coronary revascularization procedure
Time frame: 5 year
Percentage of Participants with ischemic stroke
Time frame: 5 year
Percentage of Participants with Cardiac Re-admission
Time frame: 5 year
Percentage of Participants with Adherence to medications for secondary prevention
Time frame: 5 year
Number of Participants who quit smoking
Time frame: 5 year
Symptoms status as assessed by SAQ
Time frame: 5 year
Quality of life as assessed by EQ-5D
Time frame: 5 year
Depression as assessed by PHQ-8
Time frame: 5 year
Stress as assessed by PSS-4
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 6 Mar 2018.
- Individual participant dataSharing planned: No. We will not share IPD to protect our data very well.
Related trials for Coronary Heart Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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.
Tongtong Yu, Doctor principal investigator
Shengjing Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease, run by Shengjing Hospital.
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 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Percentage of Participants with Major adverse cardiovascular events (MACE) (time frame: 5 year). 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 6 Mar 2018.