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

• Conditions: Coronary Heart Disease
• Interventions: Procedure: PCI

• Registration Number: NCT02667548
• Lead Sponsor: Shengjing Hospital

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-21
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-29
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-04
• Last Update Posted: 2018-03-06
• Primary Completion: 2021-01
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 7000

Inclusion Criteria

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

Exclusion Criteria

• Previously enrolled in the R-PUSH study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients receiving PCI	PCI	patients receiving PCI

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Major adverse cardiovascular events (MACE)	5 year	Composite of major adverse cardiovascular events (MACE) including cardiac death, non-fatal AMI, coronary revascularization procedure, or ischemic stroke

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants with all-cause death	5 year
Symptoms status as assessed by SAQ	5 year
Stress as assessed by PSS-4	5 year
Percentage of Participants with coronary revascularization procedure	5 year	coronary revascularization procedure includs any unplanned repeat PCI or surgical bypass of target or non-target vessels.
Percentage of Participants with cardiac death	5 year
Percentage of Participants with non-fatal AMI	5 year
Percentage of Participants with Cardiac Re-admission	5 year	Cardiac Re-admission includes any re-admission because of aggravation of heart failure or angia.
Percentage of Participants with Adherence to medications for secondary prevention	5 year	Taking the following medications for 6 or more days per week: aspirin, clopidogrel, ACEI/ARB, statin and beta-blockers
Percentage of Participants with ischemic stroke	5 year
Number of Participants who quit smoking	5 year
Quality of life as assessed by EQ-5D	5 year
Depression as assessed by PHQ-8	5 year