China PEACE-Retrospective CathPCI Study

Coronary Heart Disease Clinical Trial

Official title:

The China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) Prospective Study of Coronary Catheterization and Percutaneous Coronary Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01624896
• Other study ID #: WSGY-201202025-2
• Status: Completed
• Phase: N/A
• First received: June 17, 2012
• Last updated: June 29, 2014
• Start date: April 2012
• Est. completion date: October 2013

Study information

• Verified date: June 2014
• Source: China National Center for Cardiovascular Diseases
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Coronary heart disease (CHD) is one of the leading causes of mortality and morbidity. PCI, as a well-proved and booming measure in CHD management, is invasive and of high cost, however the knowledge about the real-life PCI use in China is limited. Within a nation-wide and regional representative probability sample of hospitals in China, 14,000 CAG/PCI inpatient cases will be sampled randomly from 2001 to 2011. The sampled medical records will be reviewed and abstracted in the national coordinating centre, in order to evaluate the treatment pattern, outcomes, and cost for PCI, during the past decade. Basic data and innovative evidence will accelerate evidence-based clinical practice and policy making, and improve patients outcomes in future finally.

Description:

Cardiovascular disease (CVD) is a major concern in public health globally, as well as in China, and remarkable variations of resources available and health system performance have been noted. 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 magnitude and quality of PCI, which has developed rapidly during the past several decades. Practical and applied knowledge from large unselected population is needed to guide practice and policy for quality improvement and cost reduction.

To investigate the treatment pattern and outcomes of PCI during the past decade in China, using a stratified two-stage cluster sampling design, from 70 sampled hospitals, 7,000 CAG/PCI cases will be selected in 2011, and 3,500 in 2001 and 2006 separately. Photocopies of the 14,000 medical records of CAG/PCI cases will be sent to the national coordinating centre. Demographic characteristics, medical history, clinical features, diagnostic tests, medications, procedures, and in-hospital outcomes of patients will be abstracted by well trained professional abstractors. By characterizing differences in patients' features, comparing the use of medications and procedures, and examining the in-hospital outcomes, we'll define the gaps between clinical practice and guidelines, as well as the disparities across different regions and hospitals, to evaluated the treatment pattern and outcomes in the last decade in China. New knowledge will be generated about PCI management all over China, to provide evidence for policy-making and clinical guidelines, and to improve patients prognosis in future finally.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12000
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Hospitalized patients undergoing a diagnostic cardiac catheterization and/or 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases	Ministry of Health, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe complications after PCI	Composite of severe complications after PCI including coronary artery dissection, coronary spasm, acute coronary artery occlusion, thrombosis, acute myocardial infarction, emergent coronary artery bypass graft, death	Duration of hospital stay, an expected average of 1 week	Yes