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

Coronary Heart Disease Clinical Trial

— R-PUSH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02667028
• Other study ID #: 2016PS04K01
• Status: Recruiting
• Phase: N/A
• First received: January 19, 2016
• Last updated: January 25, 2016
• Start date: October 2015
• Est. completion date: October 2019

Study information

• Verified date: January 2016
• Source: Shengjing Hospital
• Contact: Yuanyuan Dong, Doctor
• Phone: 8618940257980
• Email: dongyy[@]sj-hospital.org
• Is FDA regulated: No
• Health authority: China: Chinese Medical Association
• 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. 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.

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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

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

Intervention

Procedure:
• PCI
percutaneous coronary intervention

Locations

Country	Name	City	State
China	Shengjing Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Major adverse cardiovascular events (MACE)	Composite of major adverse cardiovascular events (MACE) includes cardiac death, non-fatal AMI, coronary revascularization procedure.	5 years	Yes
Secondary	Percentage of Participants with all-cause death		5 years	Yes
Secondary	Percentage of Participants with cardiac death		5 years	Yes
Secondary	Percentage of Participants with non-fatal AMI		5 years	Yes
Secondary	Percentage of Participants with coronary revascularization	coronary revascularization includes any unplanned repeat PCI or surgical bypass of target or non-target vessels.	5 years	Yes
Secondary	Percentage of Participants with stroke		5 years	Yes
Secondary	Percentage of Participants with Cardiac Re-admission	Cardiac Re-admission includes any re-admission because of aggravation of heart failure or angia.	5 years	Yes
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 years	No
Secondary	Number of Participants who quit smoking		5 years	No