Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05437107 |
| Other study ID # |
2016-I2M-1-009 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2017 |
| Est. completion date |
December 31, 2020 |
Study information
| Verified date |
June 2022 |
| Source |
China National Center for Cardiovascular Diseases |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Patients with atherosclerosis are at high risk of future cardiovascular disease.
Approximately 70% cardiac death and 50% myocardial infarction (MI) occurred among patients
with established coronary artery disease (CAD). These patients have a four to seven-fold risk
of fatal or non-fatal MI compared with those without CAD. Current secondary prevention
therapy, including statins and anti-platelet therapy have decreased mortality among CHD
patients. However, one out of five patients with MI experienced cardiovascular events within
one-year of discharge.
This study aims at identifying new risk factors of atherosclerosis, improving
risk-stratification among patients with CAD by using novel biomarkers and finally improving
outcome and life quality of patients. The investigators will recruit 30000 patients
undergoing elective elective coronary angiography and collect baseline characteristics,
physical examination, lab test results, angiographic characteristics, etc. Blood sample will
also be collected at baseline. Subsequently, two-year follow-up will be done to collect data
regarding patients' outcome, including cardiac death, MI, revascularization, medication, etc.
Investigators will compare baseline, imaging, blood test results between patients with and
without cardiovascular events and identify novel predictors of the occurrence and progression
of CAD.
Description:
1. Organization of the project This project involves the cooperation between different
teams. Principle investigator is responsible for all aspects of the project, including
design, executive, monitoring and report of the project. Scientific committee is
responsible for the scientific design of the registry, as well as rational design of
subsequent studies based on the registry. Data management team will monitor the logic,
validity, consistency, completeness of data and provide timely feedback to researchers.
Clinical support team and Statistics team are responsible for the medical, and data
analysis aspect of the registry respectively.
2. Data quality assurance Data are collected, submitted and stored online to the
Informatics Center of Fuwai Hospital. Data are stored and protected managed according to
national information security protection law. The following measures are adopted for
data quality control. (1) Research staff will only be given access to a
password-protected data-entry system after formal training. (2) A real-time, automated
algorithm is used to check the logic, range, validity, consistency, completeness of data
entered in the system. (3) Approximately 10% of online records are selected randomly and
checked against the source documentation. (4) Data management team will check data
quality regularly, and ask research staff to review and revise the missing, invalid and
illogical data.
3. Data dictionary Data are collected by trained experienced cardiologists and by using
standardized definition in accordance with ACC/AHA Task Force on clinical Data Standards
and NCDR-CathPCI registry Data Coder's Dictionary, including patient demographics,
clinical presentation, medical history, risk factors, physical examination, laboratory
results, clinical events, angiographic characteristics and procedural characteristics.
4. Sample size, missing data We didn't set upper limits for sample size and plan to enroll
all eligible participants admitted to Fuwai hospital, because we aim to obtain a
comprehensive understanding of the management and outcome of patients with suspected CAD
and receiving coronary angiography. According to Fuwai Hospital data, number of PCI
procedure reached 17798. Therefore we plan to enroll 30000 patients from January 2017 to
December 2018.
Several measures will be adopted to manage missing data: (1) "Required" fields are used for
key variables during data entry. (2) We conducted pilot testing to identify variables with
high rate of missing data, explore possible reasons and improve data collection. (3) Data
management team will monitor data quality periodically and send queries to researchers to
enter the missing data and check invalid data. (4) During statistical analysis phase, based
on the type, pattern and amount of missing data, appropriated methods will be used to handle
missing data.
