Lp(a) With CCTA Assessed Parameters and Clinical Outcomes

Coronary Artery Disease Clinical Trial

— CHART-ACCORD  

Official title:

Association of Lipoprotein (a) With Coronary CTA Assessed High Risk Coronary Disease Attributes and Cardiovascular Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05323227
• Other study ID #: CHART20220404
• Status: Recruiting
• Start date: March 20, 2016
• Est. completion date: May 30, 2022

Study information

• Verified date: April 2022
• Source: Shanghai Zhongshan Hospital
• Contact: Neng Dai, MD
• Phone: +8613701997266
• Email: niceday1987[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Lipoprotein(a) [Lp(a)] is a risk factor for cardiovascular events, although the underlying mechanism remains unclear. This study evaluated the relationship between Lp(a) and high-risk attributes (HRA) by coronary computed tomography angiography (CCTA) as well as their prognostic value.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 378
• Est. completion date: May 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with Lp(a) meaured within 1 week of CCTA examination.

Exclusion Criteria:

• unstable angina pectoris

• acute myocardial infarction

• New York Heart Association class III-IV heart failure

• with a history of bypass surgery

• active infection

• respiratory failure

• chronic kidney disease (estimated glomerular filtration rate [eGFR] <60 ml/min/1.73 m2)

• liver dysfunction (liver enzyme >3 upper reference limit [URL] or bilirubin >2 URL)

• malignancy

• systemic connective tissue disease

• poor CCTA imaging quality not suitable for analysis

• other situations not suitable for the study

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Diagnostic Test:
• Coronary CTA
Patients receive coroanry CTA at the discretion of the physicians in charge. And parameters including plaque burden, minimal lumen area, diameter stenosis, total plaque volume, high-risk plaque characteristics, fractional flow reserve, pullback pressure gradient, fat attenuation index will be analyzed.

Locations

Country	Name	City	State
China	Shanghai Zhongshan Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Dai N, Hwang D, Lee JM, Zhang J, Jeon KH, Paeng JC, Cheon GJ, Koo BK, Ge J. Feasibility of Quantitative Flow Ratio-Derived Pullback Pressure Gradient Index and Its Impact on Diagnostic Performance. JACC Cardiovasc Interv. 2021 Feb 8;14(3):353-355. doi: 10.1016/j.jcin.2020.10.036. Erratum in: JACC Cardiovasc Interv. 2021 Sep 13;14(17):1963. — View Citation

Shin D, Dai N, Lee SH, Choi KH, Lefieux A, Molony D, Hwang D, Kim HK, Jeon KH, Lee HJ, Jang HJ, Ha SJ, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Doh JH, Shin ES, Nam CW, Koo BK, Gwon HC, Ge J, Lee JM. Physiological Distribution and Local Severity of Coronary Artery Disease and Outcomes After Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2021 Aug 23;14(16):1771-1785. doi: 10.1016/j.jcin.2021.06.013. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association of Lp(a) level with CCTA measured Parameters	Association of Lp(a) level with CCTA measured total plaque volume	at the index procedure
Primary	Association of Lp(a) level with CCTA measured Parameters	Association of Lp(a) level with CCTA measured fractional flow reserve	at the index procedure
Primary	Association of Lp(a) level with CCTA measured Parameters	Association of Lp(a) level with CCTA measured pullback pressure gradient	at the index procedure
Primary	Association of Lp(a) level with CCTA measured Parameters	Association of Lp(a) level with CCTA measured fat attenuation index	at the index procedure
Primary	Association of Lp(a) level with CCTA measured Parameters	Association of Lp(a) level with CCTA measured high-risk plaque characteristics	at the index procedure
Primary	Major adverse cardiac events	a composite of cardiac death, any myocardial infarction, and stroke	at 24 months from index procedure
Secondary	Cardiac death	Cardiac death	at 24 months from index procedure
Secondary	Myocardial infarction	Myocardial infarction	at 24 months from index procedure
Secondary	Stroke	stroke	at 24 months from index procedure