Clinical trial NCT05323227: Lp(a) With CCTA Assessed Parameters and Clinical Outcomes
Official title: Association of Lipoprotein (a) With Coronary CTA Assessed High Risk Coronary Disease Attributes and Cardiovascular Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 378
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stable CAD patients with serum Lp(a) measured and underwent CCTA within 1 week at Zhongshan Hospital, Fudan University

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Association of Lp(a) level with CCTA measured Parameters
timeFrame: at the index procedure
measure: Association of Lp(a) level with CCTA measured Parameters
timeFrame: at the index procedure
measure: Association of Lp(a) level with CCTA measured Parameters
timeFrame: at the index procedure
measure: Association of Lp(a) level with CCTA measured Parameters
timeFrame: at the index procedure
measure: Association of Lp(a) level with CCTA measured Parameters
timeFrame: at the index procedure
measure: Major adverse cardiac events
timeFrame: at 24 months from index procedure
Secondary outcomes:
measure: Cardiac death
timeFrame: at 24 months from index procedure
measure: Myocardial infarction
timeFrame: at 24 months from index procedure
measure: Stroke
timeFrame: at 24 months from index procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
Study officials:
affiliation: Fudan University
name: Junbo Ge, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. No abstract available.
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.