Clinical trial NCT02667548: Prospective Evaluation of Prognosis of Pci Patients Using Network Data in SHengjing Hospital
Official title: Prospective Evaluation of Prognosis of Pci Patients Using Network Data in SHengjing Hospital of China Medical University
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Heart Disease
Keywords: percutaneous coronary intervention
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 7000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Previously enrolled in the R-PUSH study

Primary outcomes:
measure: Percentage of Participants with Major adverse cardiovascular events (MACE)
timeFrame: 5 year
Secondary outcomes:
measure: Percentage of Participants with all-cause death
timeFrame: 5 year
measure: Percentage of Participants with cardiac death
timeFrame: 5 year
measure: Percentage of Participants with non-fatal AMI
timeFrame: 5 year
measure: Percentage of Participants with coronary revascularization procedure
timeFrame: 5 year
measure: Percentage of Participants with ischemic stroke
timeFrame: 5 year
measure: Percentage of Participants with Cardiac Re-admission
timeFrame: 5 year
measure: Percentage of Participants with Adherence to medications for secondary prevention
timeFrame: 5 year
measure: Number of Participants who quit smoking
timeFrame: 5 year
measure: Symptoms status as assessed by SAQ
timeFrame: 5 year
measure: Quality of life as assessed by EQ-5D
timeFrame: 5 year
measure: Depression as assessed by PHQ-8
timeFrame: 5 year
measure: Stress as assessed by PSS-4
timeFrame: 5 year
Other outcomes:
measure: Cognitive function as assessed by MMSE
timeFrame: 5 year
measure: 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)
timeFrame: 5 year
Locations:
Study officials:
affiliation: Shengjing Hospital
name: Tongtong Yu, Doctor
role: PRINCIPAL_INVESTIGATOR
References: