Lp(a) With CCTA Assessed Parameters and Clinical Outcomes

NCT05323227 | Unknown

• 1 other identifier: CHART20220404
• Study Type: observational
• Target: 378
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (6)

• Association of Lp(a) level with CCTA measured Parameters

  Association of Lp(a) level with CCTA measured total plaque volume

  at the index procedure

• Association of Lp(a) level with CCTA measured Parameters

  Association of Lp(a) level with CCTA measured fractional flow reserve

  at the index procedure

• Association of Lp(a) level with CCTA measured Parameters

  Association of Lp(a) level with CCTA measured pullback pressure gradient

  at the index procedure

• Association of Lp(a) level with CCTA measured Parameters

  Association of Lp(a) level with CCTA measured fat attenuation index

  at the index procedure

• 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

• Major adverse cardiac events

  a composite of cardiac death, any myocardial infarction, and stroke

  at 24 months from index procedure

Secondary Outcomes (3)

• Cardiac death

  at 24 months from index procedure

• Myocardial infarction

  at 24 months from index procedure

• Stroke

  at 24 months from index procedure

Study Arms (2)

Group 1

Patients with Lp(a) \<60mg/dL

Diagnostic Test: Coronary CTA

Group 2

Patients with Lp(a) ≥60 mg/dL

Diagnostic Test: Coronary CTA

Interventions

Coronary CTA DIAGNOSTIC_TEST

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.

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 33541549 BACKGROUND

• 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.

  PMID: 34412795 BACKGROUND

• Dai N, Chen Z, Zhou F, Zhou Y, Hu N, Duan S, Wang W, Yu Y, Zhang L, Qian J, Ge J. Association of Lipoprotein (a) With Coronary-Computed Tomography Angiography-Assessed High-Risk Coronary Disease Attributes and Cardiovascular Outcomes. Circ Cardiovasc Imaging. 2022 Dec;15(12):e014611. doi: 10.1161/CIRCIMAGING.122.014611. Epub 2022 Dec 12.

  PMID: 36503252 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Junbo Ge, Professor

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neng Dai, MD

CONTACT

+8613701997266; niceday1987@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 12, 2022
• Study Start: March 20, 2016
• Primary Completion: April 30, 2022
• Study Completion: May 30, 2022
• Last Updated: April 12, 2022

Record last verified: 2022-04

Locations

CN (1)