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

NCT ID: NCT02667028

Last Updated: 2016-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2019-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Heart Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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patients receiving PCI

patients receiving percutaneous coronary intervention(PCI)

PCI

Intervention Type PROCEDURE

percutaneous coronary intervention

Interventions

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PCI

percutaneous coronary intervention

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shengjing Hospital

OTHER

Sponsor Role lead

Responsible Party

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YU Tong-tong

attending physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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tongtong yu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Shengjing Hospital

Locations

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Shengjing Hospital

Shenyang, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuanyuan Dong, Doctor

Role: CONTACT

8618940257980

zhaoqing sun, Doctor

Role: CONTACT

8618940258076

Facility Contacts

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Tongtong Yu

Role: primary

8618940259900

Zhaoqing Sun

Role: backup

8618940258076

Other Identifiers

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2016PS04K01

Identifier Type: -

Identifier Source: org_study_id

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