China Cardiovascular Surgery Registry (CCSR)

December 15, 2015 updated by: China National Center for Cardiovascular Diseases
China Cardiovascular Surgery Registry (CCSR) Study is a national database for coronary artery bypass grafting (CABG) and valve surgery performed in 87 hospitals with cardiovascular surgery volume > 100 per year. The aims of CCSR Study are: (i) report the characteristics of patient, the quality and evolvement of CABG and valve procedures in China, (ii) build and valid surgical risk assessment tools for Chinese population, (iii) provide databases for clinical studies, and quality improvement initiatives.

Study Overview

Status

Unknown

Conditions

Detailed Description

The volume of cardiac surgery in China is increasing rapidly at a rate of approximately 10% annually, and has approached 207,881 at the year of 2013. Coronary artery bypass grafting (CABG) and valve procedures account for 41% of all. With the aging population, rising prevalence of cardiovascular diseases, and rapid economic development in China, the volume of cardiac procedures will continuously rise for years. In light of the burgeoning volume of cardiac procedures, considering the imbalance of economic development among regions, and the lack of standardized surgeon training system, critical concern with regards to the quality of cardiac surgery has been raised.

Under this circumstance, national registry to continuously collect patient-by-patient data for cardiovascular surgery is critically important to (i) report the characteristics of patient, the quality and evolvement of procedures, (ii) build and valid surgical risk assessment tools, (iii) provide databases for clinical studies, and quality improvement initiatives, (iv) promote international exchanges and cooperation. Following the example of national cardiac procedure databases, such as The Society of Thoracic Surgeons (STS) National Database and The European Association for Cardio-Thoracic Surgery (EACTS) Database, Fuwai Hospital, as one of the largest cardiac surgical care and research centers in China, leveraged an initiative to start the first multicenter cardiac surgery registry in Chinese mainland at 2004. The investigators started with 32 participating sites and registered CABG surgery during the first 2 years. From 2007, the investigators have included valve surgery as well. By the end of 2012, 66 coordinating sites have participated into this voluntary database continuously or intermittently, enrolled 61,558 surgery data. This database has become the most representative data source for adult cardiac surgery in China. This registry has (i) reported the performance and quality of adult cardiac surgery in China, shown that the observed and risk-adjusted in-hospital mortality rate of isolated CABG in China is 2.2% and 1.9% respectively, and identified certain variation among regions and sites, (ii) released an in-hospital mortality risk prediction system for CABG named SinoSCORE, which suit Chinese population better, (iii) worked with EACTS and merged both databases together for the 4th Adult Cardiac Surgical Database Report, (iv) acted as one platform and data source for clinical studies, published 14 papers in international indexed journals.

In order to extend the volume of participating sites, and build a representative database for the performance, in-hospital as well as 1-year outcomes of CABG and/or valve surgery in large cardiac surgery centers in China, at the year of 2013, China National Center for Cardiovascular Diseases (NCCD) and Fuwai Hospital leveraged The China Cardiovascular Surgery Registry (CCSR) network to push the CCSR Study forward. The CCSR Study established a network of 90 participating sites with cardiovascular surgery volume > 100 per year, and capability of performing CABG and/or valve surgery. The participating sites are required to consecutively and routinely submit CABG and valve surgery data regarding patients' personal information, risk factors, surgery performance, in-hospital outcomes and prescription drugs, through a web-based and paperless data collection system. The investigators also encourage all sites to interview patients at 1-month and 1-year after index procedure for mid-term outcomes and medications after discharge. The investigators conduct routine remote and on-site monitoring and auditing to ensure integrity and accuracy of data. Ethics Committee of Fuwai Hospital approved the study design and audits the conducting yearly.

For in-hospital data collection, CCSR established 11 modules (patient basic information, preoperative risks, cardiovascular presentation, cardiac examination, general information on operation, CABG, valve surgery, other surgeries, post-operative complications, pre-operative medication and medical order at discharge), 416 items, among which 157 items are core dataset, 259 are extended dataset. The core dataset is a mandatory set of variables believed to be necessary for accurate representation of clinical practice, risk model development, and analysis. The extended dataset includes less critical but still important fields that are strongly encouraged to be collected but are not mandatory for submitting. The creation of custom fields is permissible so that sites can collect specific information that is desired by themselves.

The investigators adapted Clinical Data Interchange Standards Consortium (CDISC) Standard for data collection and merging among international databases. The investigators established input items comparable to those of the STS National Database, the common terminologies and the definitions from STS National Database was adopted as well.

Coordinators are requested to consecutively register 5 variables regarding basic information of patients undergoing isolated or combined CABG and/or valve surgery in their hospital in 3 days after the surgery. The basic information includes name, sex, date of birth, type of surgery and ID number. The investigators request the coordinators to submit the complete in-hospital data within 28 days after the surgery. The investigators also developed a standard data interface for all in-hospital data elements. If the quality of participating sites' exported data from Hospital Information System meets the safety and quality criteria, it is also acceptable of these sites to export and import in-hospital data automatically instead of manual submitting.

The investigators encourage all participating sites to invite patients to join the prospective follow-up cohort and interview patients after discharge, but the follow-up interview is optional. Coordinators from participating sites interview the patients who have signed the informed consent during their index hospitalization and 1-month, 1-year after the index cardiac surgery face to face and by telephone. The data include major cardiovascular and cerebral outcomes, readmission, and self-administration.

In order to ensure the follow-up data authenticity, with the permission of patients and participating sites, NCC interviews patients at 3-month after their cardiac surgery using the same questionnaire.

Data variables have been added for internal quality and integrity checks. If any component of the required mandatory data elements are missing, or any of the validation roles of logic aren't meet, the data will be automatically rejected. In order to audit the accuracy of in-hospital data, the investigators randomly select 10-20% of each participating sites' in-hospital data, and require the coordinators to scan the coordinating medical record, and transferred to NCC using encryption flash drive. 2 physicians from NCC abstract all medical record data independently, and compare the data between NCC data abstraction and coordinators' database. The accuracy report of each sites are fed back to each participating site yearly. The on-site auditing are conducted once a year for each site. The main aim of on-site auditing is to ensure the consecutiveness of data registry. The investigators randomly select a period of time to check original record of surgery, and abstract data regarding patient ID and in-hospital outcomes. Any mismatch of auditing data with submitting data will be reported to NCC and participating sites.

Study Type

Observational

Enrollment (Anticipated)

90000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Recruiting
        • National Center for Cardiovascular Diseases, Fuwai Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients underwent isolated or combined coronary artery bypass grafting and/or surgical treatment for heart valve diseases

Description

Inclusion Criteria:

  • patients underwent isolated or combined coronary artery bypass grafting and/or surgical treatment for heart valve diseases

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Patients underwent isolated or combined coronary artery bypass grafting surgery
2
Patients underwent isolate or combined surgical treatment for heart valve disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
composite of post-operative all-cause mortality and major complications
Time Frame: participants will be followed for the duration of hospital stay after the index cardiac operation, an expected average of 2 weeks
composite of death of any cause, reoperation, myocardial infarction, stroke, renal failure, pulmonary embolism, atrial fibrillation during the postoperative hospitalization
participants will be followed for the duration of hospital stay after the index cardiac operation, an expected average of 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
major adverse cardiac events
Time Frame: 30 days
composite of major adverse cardiac events (MACE) including death, myocardial infarction and/or revascularization
30 days
major adverse cardiac events
Time Frame: 1 year
composite of major adverse cardiac events (MACE) including death, myocardial infarction and/or revascularization
1 year
readmission
Time Frame: 30 days
composite of major adverse cardiac events (MACE) including death, myocardial infarction and/or revascularization
30 days
readmission
Time Frame: 1 year
composite of major adverse cardiac events (MACE) including death, myocardial infarction and/or revascularization
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Collaborators

Ministry of Science and Technology of the People´s Republic of China

Investigators

  • Study Chair: Shengshou Hu, PhD, MD, Chinese Academy of Medical Sciences, Fuwai Hospital
  • Study Director: Zhe Zheng, PhD, MD, Chinese Academy of Medical Sciences, Fuwai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

March 22, 2015

First Submitted That Met QC Criteria

March 23, 2015

First Posted (Estimate)

March 26, 2015

Study Record Updates

Last Update Posted (Estimate)

December 16, 2015

Last Update Submitted That Met QC Criteria

December 15, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOST-2011BAI11B21
  • MOST-2011BAI11B02 (Other Grant/Funding Number: Ministry of Science and Technology of China)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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