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

Coronary Heart Disease Clinical Trial

— P-PUSH  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02667548
• Other study ID #: 2016PS04K02
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 21, 2016
• Last updated: March 4, 2018
• Start date: January 2016
• Est. completion date: January 2021

Study information

• Verified date: March 2018
• Source: Shengjing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 7000
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Previously enrolled in the R-PUSH study

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Procedure:
• PCI
percutaneous coronary intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cognitive function as assessed by MMSE		5 year
Other	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
Primary	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	Percentage of Participants with all-cause death		5 year
Secondary	Percentage of Participants with cardiac death		5 year
Secondary	Percentage of Participants with non-fatal AMI		5 year
Secondary	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
Secondary	Percentage of Participants with ischemic stroke		5 year
Secondary	Percentage of Participants with Cardiac Re-admission	Cardiac Re-admission includes any re-admission because of aggravation of heart failure or angia.	5 year
Secondary	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
Secondary	Number of Participants who quit smoking		5 year
Secondary	Symptoms status as assessed by SAQ		5 year
Secondary	Quality of life as assessed by EQ-5D		5 year
Secondary	Depression as assessed by PHQ-8		5 year
Secondary	Stress as assessed by PSS-4		5 year