China PEACE-Retrospective CathPCI Study

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, China
Information provided by (Responsible Party):
China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier:
NCT01624896
First received: June 17, 2012
Last updated: June 29, 2014
Last verified: June 2014
  Purpose

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.


Condition
Coronary Heart Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: The China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) Prospective Study of Coronary Catheterization and Percutaneous Coronary Intervention

Resource links provided by NLM:


Further study details as provided by China National Center for Cardiovascular Diseases:

Primary Outcome Measures:
  • Severe complications after PCI [ Time Frame: Duration of hospital stay, an expected average of 1 week ] [ Designated as safety issue: Yes ]
    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


Enrollment: 12000
Study Start Date: April 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01624896

Sponsors and Collaborators
China National Center for Cardiovascular Diseases
Ministry of Health, China
Investigators
Principal Investigator: Lixin Jiang, M.D., Ph.D. China National Center for Cardiovascular Diseases
Principal Investigator: Harlan M Krumholz, M.D., S.M. Yale University
  More Information

No publications provided

Responsible Party: China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT01624896     History of Changes
Other Study ID Numbers: WSGY-201202025-2
Study First Received: June 17, 2012
Last Updated: June 29, 2014
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 11, 2014