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Coronary Artery DiseaseCHART-ACCORDNCT05323227

Lp(a) With CCTA Assessed Parameters and Clinical Outcomes

An observational study of Coronary Artery Disease, run by Shanghai Zhongshan Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Coronary CTA
How many people
378 participants
Where
1 siteChina
Study dates
20 Mar 2016to 30 May 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Stable CAD patients with serum Lp(a) measured and underwent CCTA within 1 week at Zhongshan Hospital, Fudan University

Who may be able to join

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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Neng Dai, MD contact

+8613701997266

niceday1987@hotmail.com

China1 site, 1 recruiting

  • Shanghai Zhongshan Hospital

    Shanghai

    Neng Dai, MD, +8613701997266, niceday1987@hotmail.com

    Junbo Ge, MD

    Recruiting

Other trials in China

About this study

Official title: 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.

Being tested
Coronary CTA
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary CTADiagnostic 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.

Study groups in NCT05323227
Study groupRoleWhat they receive
Group 1Patients with Lp(a) <60mg/dL
Receives: Diagnostic Test: Coronary CTA
Group 2Patients with Lp(a) ≥60 mg/dL
Receives: Diagnostic Test: Coronary CTA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Association of Lp(a) level with CCTA measured Parameters

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

    Measured: at the index procedure

  2. Association of Lp(a) level with CCTA measured Parameters

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

    Measured: at the index procedure

  3. Association of Lp(a) level with CCTA measured Parameters

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

    Measured: at the index procedure

  4. Association of Lp(a) level with CCTA measured Parameters

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

    Measured: at the index procedure

  5. Association of Lp(a) level with CCTA measured Parameters

    Association of Lp(a) level with CCTA measured high-risk plaque characteristics

    Measured: at the index procedure

  6. Major adverse cardiac events

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

    Measured: at 24 months from index procedure

Secondary outcomes (3)

  1. Cardiac death

    Cardiac death

    Measured: at 24 months from index procedure

  2. Myocardial infarction

    Myocardial infarction

    Measured: at 24 months from index procedure

  3. Stroke

    stroke

    Measured: at 24 months from index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2022
  2. Study start20 Mar 2016
  3. Primary completion30 Apr 2022 (estimated)
  4. Study completion30 May 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
378 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05323227
Sponsor's protocol ID
CHART20220404
Acronym
CHART-ACCORD
Status last verified
Apr 2022
First submitted
4 Apr 2022
Last updated
12 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 33541549

  • 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.

    PubMed 34412795

  • 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.

    PubMed 36503252

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Shanghai Zhongshan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Neng Dai, MD (+8613701997266, niceday1987@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Association of Lp(a) level with CCTA measured Parameters (time frame: at the index procedure). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05323227, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.

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