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Coronary Atherosclerosis Disease Early Identification and Risk Stratification by Noninvasive Imaging

Coronary Atherosclerosis Disease Early Identification and Risk Stratification by Noninvasive Imaging :A Cohort Study of China

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03518437
Acronym
Creation
Enrollment
30000
Registered
2018-05-08
Start date
2016-09-30
Completion date
2020-09-30
Last updated
2018-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

coronary artery disease, CT, MACE

Brief summary

The investigator prospectively enroll 30,000 outpatients who were suspected of coronary artery disease (CAD) and underwent cardiac computed tomography angiography (CTA). The endpoint was major adverse cardiac events (MACE).The investigator aim to evaluate the prognostic value of CTA, risk factors and bio-markers for MACE.

Detailed description

The investigator prospectively enroll 30,000 outpatients who were suspected of coronary artery disease (CAD) and underwent cardiac computed tomography (CT). Cardiac CT was assessed for coronary artery calcification score (CACS) and the extent, the location, the stenosis severity, and the composition of the plaque in CTA. The base line information was recorded, including risk factors, drugs, bio-markers, and psychological. The endpoint was MACE, defined as composite cardiac death, nonfatal myocardial infarction (MI).we aim to evaluate the prognostic value of CTA, risk factors and bio-markers for major adverse cardiac events (MACE).

Interventions

None listed

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. suspected of coronary heart disease, coronary CTA has been completed. 2. age \> 18 years old. 3. have biochemical test results. 4. signed informed consent.

Exclusion criteria

1. malignant tumor, severe liver and kidney diseases. 2. combination of cardiomyopathy, valvular disease, congenital heart disease, a variety of reasons the left cardiac insufficiency.

Design outcomes

Primary

MeasureTime frameDescription
Major Adverse Cardiac Events3 yearscardiac death, myocardial infarction (Cardiac death was defined as death due to acute myocardial infarction, ventricular arrhythmias, refractory heart failure or cardiogenic shock. The investigator reviewed all available data to determine whether a cardiac etiology was the immediate cause of death and categorized cardiac deaths into sudden cardiac death and nonsudden cardiac death. Sudden cardiac death was defined by published criteria . myocardial infarction was defined based on the criteria of typical chest pain, elevated cardiac enzyme levels and typical alterations of the electrocardiogram. )

Countries

China

Contacts

Primary Contactbin lu, M.D.
blu@vip.sina.com88322656
Backup ContactZhi-hui Hou, M.D.
konglingyihui@126.com88322656

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026