Coronary Atherosclerosis Disease Early Identification and Risk Stratification by Noninvasive Imaging

Coronary Artery Disease Clinical Trial

— Creation  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03518437
• Other study ID #: CIFuwaiHospital-1
• Status: Recruiting
• Start date: September 2016
• Est. completion date: September 2020

Study information

• Verified date: April 2018
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: bin lu, M.D.
• Phone: 88322656
• Email: blu[@]vip.sina.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30000
• Est. completion date: September 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
China	Binlu	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

Hou ZH, Lu B, Gao Y, Jiang SL, Wang Y, Li W, Budoff MJ. Prognostic value of coronary CT angiography and calcium score for major adverse cardiac events in outpatients. JACC Cardiovasc Imaging. 2012 Oct;5(10):990-9. doi: 10.1016/j.jcmg.2012.06.006. — View Citation

Min JK, Dunning A, Lin FY, Achenbach S, Al-Mallah M, Budoff MJ, Cademartiri F, Callister TQ, Chang HJ, Cheng V, Chinnaiyan K, Chow BJ, Delago A, Hadamitzky M, Hausleiter J, Kaufmann P, Maffei E, Raff G, Shaw LJ, Villines T, Berman DS; CONFIRM Investigator — View Citation

SCOT-HEART investigators. CT coronary angiography in patients with suspected angina due to coronary heart disease (SCOT-HEART): an open-label, parallel-group, multicentre trial. Lancet. 2015 Jun 13;385(9985):2383-91. doi: 10.1016/S0140-6736(15)60291-4. Ep — View Citation

Shah R, Foldyna B, Hoffmann U. Outcomes of anatomical vs. functional testing for coronary artery disease : Lessons from the PROMISE trial. Herz. 2016 Aug;41(5):384-90. doi: 10.1007/s00059-016-4451-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiac Events	cardiac 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. )	3 years