NCT01624896

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 21, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

July 1, 2014

Status Verified

June 1, 2014

Enrollment Period

1.5 years

First QC Date

June 17, 2012

Last Update Submit

June 29, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Lixin Jiang, M.D., Ph.D.

    China National Center for Cardiovascular Diseases

    PRINCIPAL INVESTIGATOR
  • Harlan M Krumholz, M.D., S.M.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2012

First Posted

June 21, 2012

Study Start

April 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

July 1, 2014

Record last verified: 2014-06