Lp(a) With CCTA Assessed Parameters and Clinical Outcomes (CHART-ACCORD)

April 4, 2022 updated by: Shanghai Zhongshan Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

378

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai Zhongshan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Patients with Lp(a) <60mg/dL
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.
Group 2
Patients with Lp(a) ≥60 mg/dL
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac death
Time Frame: at 24 months from index procedure
Cardiac death
at 24 months from index procedure
Myocardial infarction
Time Frame: at 24 months from index procedure
Myocardial infarction
at 24 months from index procedure
Stroke
Time Frame: at 24 months from index procedure
stroke
at 24 months from index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Principal Investigator: Junbo Ge, Professor, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2016

Primary Completion (Anticipated)

April 30, 2022

Study Completion (Anticipated)

May 30, 2022

Study Registration Dates

First Submitted

April 4, 2022

First Submitted That Met QC Criteria

April 4, 2022

First Posted (Actual)

April 12, 2022

Study Record Updates

Last Update Posted (Actual)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHART20220404

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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