Clinical trial NCT02400125: China Cardiovascular Surgery Registry
Official title: China Cardiovascular Surgery Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Bypass Grafting
Surgical Treatment for Heart Valve Diseases
Keywords: Patient Registry
Coronary Artery Bypass
Cardiac Valve Annuloplasty
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Science and Technology of the People´s Republic of China
First posted: 2015-03-26
Enrollment: 90000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients underwent isolated or combined coronary artery bypass grafting and/or surgical treatment for heart valve diseases

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* none

Primary outcomes:
measure: composite of post-operative all-cause mortality and major complications
timeFrame: participants will be followed for the duration of hospital stay after the index cardiac operation, an expected average of 2 weeks
Secondary outcomes:
measure: major adverse cardiac events
timeFrame: 30 days
measure: major adverse cardiac events
timeFrame: 1 year
measure: readmission
timeFrame: 30 days
measure: readmission
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Center for Cardiovascular Diseases, Fuwai Hospital
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Shengshou Hu, PhD, MD
role: STUDY_CHAIR
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Zhe Zheng, PhD, MD
role: STUDY_DIRECTOR
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