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

NCT ID: NCT02667548

Last Updated: 2018-03-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 7000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2021-01-31

Brief 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. 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.

Conditions

Coronary Heart Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

patients receiving PCI

patients receiving PCI

PCI

Intervention Type: PROCEDURE

percutaneous coronary intervention

Interventions

PCI

percutaneous coronary intervention

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Previously enrolled in the R-PUSH study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shengjing Hospital

OTHER

Sponsor Role: lead

Responsible Party

YU Tong-tong

attending physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tongtong Yu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Shengjing Hospital

Other Identifiers

2016PS04K02

Identifier Type: -

Identifier Source: org_study_id