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Coronary Heart DiseaseR-PUSHNCT02667028

Retrospective Evaluation of Prognosis of Pci Patients Using Network Data in SHengjing Hospital

An observational study of Coronary Heart Disease, run by Shengjing Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
3,000 participants
Where
1 siteChina
Study dates
Oct 2015to Oct 2019
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 receiving PCI in department of Cardiology,Shengjing Hospital of China Medical University from January 1, 2010 to October 31, 2014

Who may be able to join

  • Hospitalized patients undergoing a percutaneous coronary intervention (PCI) for coronary lesions.

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Yuanyuan Dong, Doctor contact

8618940257980

dongyy@sj-hospital.org

zhaoqing sun, Doctor contact

8618940258076

sunzhaoqing@vip.163.com

China1 site, 1 recruiting
  • Shengjing Hospital

    Shenyang, Liaoning, 110004

    Tongtong Yu, 8618940259900, workhard31@vip.163.com

    Zhaoqing Sun, 8618940258076, sunzhaoqing@vip.163.com

    Recruiting

Other trials in China

About this study

Official title: Retrospective 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. In a large-scale hospital in Northeast China, the investigators will examine various factors of 3007 consecutive PCI inpatient cases from January 1, 2010 to October 31, 2014. The medical records will be reviewed and abstracted to evaluate the clinical treatment pattern and outcomes. Basic data and innovative evidence will accelerate evidence-based clinical practice, and 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. In addition, little information is available about the practical and applied knowledge from large unselected population and is used to guide practice for quality improvement.

To investigate the treatment pattern and outcomes of PCI in a real-world clinical setting, 3007 consecutive PCI cases will be selected from January 1, 2010 to October 31, 2014, in a large-scale hospital in Northeast China.At first, the investigators identified all PCI patients from PACS (Picture Archiving and Communication Systems) of the interventional imaging data from January 1, 2010 to October 31, 2014 and assigned each case a unique study ID. Then, the investigators abstracted comprehensive clinical data and procedural data. Comprehensive clinical data came from electronic medical records, including patient demographic characteristics, past cardiac and noncardiac history, patient clinical characteristics on hospital admission, laboratory measurements, procedure-related complications and use of cardiac medications during the index hospitalization and at discharge. 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. The first clinical follow-up was assessed in October 2015 by direct hospital visits or phone interviews of patient's general practitioner/cardiologist, patient himself, or his family for all cases. A secondary clinical follow-up will be assessed individually if the three-year-follow-up of the patient was available. A third clinical follow-up will be assessed individually if the five-year-follow-up of the patient was available. All events were obtained from the patients' medical records. If these data were unavailable, status was ascertained by a telephone call to the patient's referring hospital physician. All events were adjudicated and classified by 2 cardiologists. By characterizing differences in patients' features, comparing the use of medications and procedures, and examining the outcomes, we'll define the gaps between clinical practice and guidelines to evaluated the treatment pattern and outcomes. New knowledge will be generated about PCI management to provide evidence for clinical guidelines, and to improve patients prognosis in future finally.

Being tested
PCI
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 groups in NCT02667028
Study groupRoleWhat they receive
patients receiving PCIpatients receiving percutaneous coronary intervention(PCI)
Receives: Procedure: PCI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with Major adverse cardiovascular events (MACE)

    Composite of major adverse cardiovascular events (MACE) includes cardiac death, non-fatal AMI, coronary revascularization procedure.

    Measured: 5 years

Secondary outcomes (8)
  1. Percentage of Participants with all-cause death

    Measured: 5 years

  2. Percentage of Participants with cardiac death

    Measured: 5 years

  3. Percentage of Participants with non-fatal AMI

    Measured: 5 years

  4. Percentage of Participants with coronary revascularization

    coronary revascularization includes any unplanned repeat PCI or surgical bypass of target or non-target vessels.

    Measured: 5 years

  5. Percentage of Participants with stroke

    Measured: 5 years

  6. Percentage of Participants with Cardiac Re-admission

    Cardiac Re-admission includes any re-admission because of aggravation of heart failure or angia.

    Measured: 5 years

  7. 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 years

  8. Number of Participants who quit smoking

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2016 (estimated)
  2. Study startOct 2015
  3. Primary completionOct 2019 (estimated)
  4. Study completionOct 2019 (estimated)

Resources

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
Retrospective
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02667028
Sponsor's protocol ID
2016PS04K01
Acronym
R-PUSH
Status last verified
Jan 2016
First submitted
19 Jan 2016
Last updated
28 Jan 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No: We will not share IPD to protect our data very well.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Heart Disease, run by Shengjing 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 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 28 Jan 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 Yuanyuan Dong, Doctor (8618940257980, dongyy@sj-hospital.org), or a site near the patient. 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 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 28 Jan 2016.

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