Prospective Evaluation of Prognosis of Pci Patients Using Network Data in SHengjing Hospital (P-PUSH)

Prospective 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. 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.

Study Overview

• Status: Unknown
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Procedure: PCI

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 Type: Observational
• Enrollment (Anticipated): 7000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

In department of Cardiology,Shengjing Hospital of China Medical University, 7000 hospitalized patients undergoing Percutaneous Coronary Intervention will be enrolled consecutively.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Previously enrolled in the R-PUSH study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients receiving 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)	Composite of major adverse cardiovascular events (MACE) including cardiac death, non-fatal AMI, coronary revascularization procedure, or ischemic stroke	5 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with all-cause death		5 year
Percentage of Participants with cardiac death		5 year
Percentage of Participants with non-fatal AMI		5 year
Percentage of Participants with coronary revascularization procedure	coronary revascularization procedure includs any unplanned repeat PCI or surgical bypass of target or non-target vessels.	5 year
Percentage of Participants with ischemic stroke		5 year
Percentage of Participants with Cardiac Re-admission	Cardiac Re-admission includes any re-admission because of aggravation of heart failure or angia.	5 year
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	5 year
Number of Participants who quit smoking		5 year
Symptoms status as assessed by SAQ		5 year
Quality of life as assessed by EQ-5D		5 year
Depression as assessed by PHQ-8		5 year
Stress as assessed by PSS-4		5 year

Other Outcome Measures

Outcome Measure	Time Frame
Cognitive function as assessed by MMSE	5 year
Sexual activity as assessed by a question: Have participants had sex or sexual activity since participants were hospitalized for heart attack or heart problem? Response Options:Dichotomous (Y/N)	5 year

Collaborators and Investigators

• Sponsor: Shengjing Hospital
• Investigators: Principal Investigator: Tongtong Yu, Doctor, Shengjing Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: January 21, 2016
• First Submitted That Met QC Criteria: January 26, 2016
• First Posted (Estimate): January 29, 2016

Study Record Updates

• Last Update Posted (Actual): March 6, 2018
• Last Update Submitted That Met QC Criteria: March 4, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 2016PS04K02

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.