Retrospective Evaluation of Prognosis of Pci Patients Using Network Data in SHengjing Hospital (R-PUSH)

January 25, 2016 updated by: YU Tong-tong, Shengjing Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients receiving PCI in department of Cardiology,Shengjing Hospital of China Medical University from January 1, 2010 to October 31, 2014

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients receiving PCI
patients receiving percutaneous coronary intervention(PCI)
Procedure: PCI
percutaneous coronary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Major adverse cardiovascular events (MACE)
Time Frame: 5 years
Composite of major adverse cardiovascular events (MACE) includes cardiac death, non-fatal AMI, coronary revascularization procedure.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with all-cause death
Time Frame: 5 years
5 years
Percentage of Participants with cardiac death
Time Frame: 5 years
5 years
Percentage of Participants with non-fatal AMI
Time Frame: 5 years
5 years
Percentage of Participants with coronary revascularization
Time Frame: 5 years
coronary revascularization includes any unplanned repeat PCI or surgical bypass of target or non-target vessels.
5 years
Percentage of Participants with stroke
Time Frame: 5 years
5 years
Percentage of Participants with Cardiac Re-admission
Time Frame: 5 years
Cardiac Re-admission includes any re-admission because of aggravation of heart failure or angia.
5 years
Percentage of Participants with adherence to medications for secondary prevention
Time Frame: 5 years
Taking the following medications for 6 or more days per week: aspirin, clopidogrel, ACEI/ARB, statin and beta-blockers
5 years
Number of Participants who quit smoking
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shengjing Hospital

Investigators

  • Principal Investigator: Tongtong Yu, Doctor, Shengjing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

January 19, 2016

First Submitted That Met QC Criteria

January 25, 2016

First Posted (Estimate)

January 28, 2016

Study Record Updates

Last Update Posted (Estimate)

January 28, 2016

Last Update Submitted That Met QC Criteria

January 25, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016PS04K01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will not share IPD to protect our data very well.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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