Clinical trial NCT01624896: China PEACE-Retrospective CathPCI Study
Official title: The China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) Prospective Study of Coronary Catheterization and Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Health, China
First posted: 2012-06-21
Enrollment: 12000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Using a stratified two-stage cluster sampling design, 70 hospitals will be selected from different regions in China, and 7,000 PCI inpatient cases will be selected in 2011, and 3,500 in 2001 and 2006 separately, from these sample hospitals.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Hospitalized patients undergoing a diagnostic cardiac catheterization and/or percutaneous coronary intervention (PCI) for coronary lesions.

Exclusion Criteria:

Primary outcomes:
measure: Severe complications after PCI
timeFrame: Duration of hospital stay, an expected average of 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: China National Center for Cardiovascular Diseases
name: Lixin Jiang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Harlan M Krumholz, M.D., S.M.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li J, Dharmarajan K, Li X, Lin Z, Normand SL, Krumholz HM, Jiang L; China PEACE Collaborative Group. Protocol for the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) retrospective study of coronary catheterisation and percutaneous coronary intervention. BMJ Open. 2014 Mar 7;4(3):e004595. doi: 10.1136/bmjopen-2013-004595.