Lp(a) With CCTA Assessed Parameters and Clinical Outcomes

NCT ID: NCT05323227

Last Updated: 2022-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

378 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-20

Study Completion Date

2022-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group 1

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

Coronary CTA

Intervention Type 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 2

Patients with Lp(a) ≥60 mg/dL

Coronary CTA

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Junbo Ge, Professor

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Shanghai Zhongshan Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Neng Dai, MD

Role: CONTACT

+8613701997266

Facility Contacts

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Neng Dai, MD

Role: primary

+8613701997266

References

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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.

Reference Type BACKGROUND
PMID: 33541549 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34412795 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36503252 (View on PubMed)

Other Identifiers

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CHART20220404

Identifier Type: -

Identifier Source: org_study_id

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