CClinicalTrials.gg
Not yet recruitingNCT06248138Updated Feb 8, 2024

Factors Related to the Progression of Non-target Coronary Lesions

An observational study in Coronary Stenosis, sponsored by Mei Gao. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-08.

Sponsored by Mei Gao · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 6 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
1,111
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this observational study is to learn about correlation between traditional risk factors and emerging risk factors on the progression of non-target coronary lesions in patients with non-target lesions on at least two coronary angiographies at the First Affiliated Hospital of Shandong First Medical University. The main question it aims to answer is what the correlation between emerging risk factors and progression of coronary non-target lesions, and try to explore the powerful predictors of progression of coronary non-target lesions and cardiovascular events.

Participants will be divided into two groups based on coronary angiography results:

  1. progress group:There is at least one major coronary artery (left main artery, left anterior descending artery, left circumflex artery or the right coronary artery) had non-target lesions, and the coronary artery stenosis rate reached the progressive level on follow-up angiography.
  2. Non-progress groups: On repeat angiography, the rate of coronary stenosis did not reach progressive levels.
Read the detailed description

The laboratory and auxiliary examination indexes of the study participants were collected prior to two coronary angiography (CAG) procedures, encompassing blood cell counts, glucose metabolism, lipid metabolism, renal function, cardiac function, inflammatory factors, etc. Quantitative flow fraction (QFR) was employed for assigning values to coronary artery images and analyzing lesion information (including plaque progression and non-progression). The correlation between conventional risk factors, lipoprotein(a), homocysteine, and other emerging risk factors with the progression of non-target coronary lesions was analyzed; furthermore, the predictive value of emerging risk factors for non-target coronary lesion progression was evaluated.

02

Conditions studied

  • Coronary Stenosis

Keywords

  • Coronary heart disease
  • Atherosclerotic progression
  • Non-target coronary lesion
  • Quantitative flow ratio
03

In context

Coronary Stenosis

302 studies on the registry are indexed under Coronary Stenosis; 63 are open to participants now.

This study's planned enrollment of 1,111 is above the median of 200 across 132 observational studies indexed under Coronary Stenosis.

Browse Coronary Stenosis studies →

Lead sponsor

Mei Gao is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with non-target lesions who underwent at least two instances of coronary angiography at the First Affiliated Hospital of Shandong First Medical University from January 2017 to present were included in the study.

Inclusion criteria

  1. Age > 18 years old;
  2. Participants underwent at least two coronary angiography examinations in our hospital, and the time interval between the two angiography examinations was ≥12 months;
  3. At the first angiography, there is 20% to 70% stenosis in the coronary artery lesion, and no indication or condition for intervention.

Exclusion criteria

Exclusion Criteria:

  1. Participants had a documented medical history of various heart diseases, including congenital heart disease, pulmonary heart disease, valvular disease, cardiomyopathy, etc.
  2. Angiography or serum collection was conducted within 7 days following the onset of acute myocardial infarction.
  3. Exclusion criteria included uncontrolled severe arrhythmia and severe hepatic and renal dysfunction.
  4. Patients with tumor or other autoimmune diseases were excluded from the study.
  5. Incomplete clinical information, biochemical test information, coronary angiography data, and imaging data were considered as exclusion factors.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
1,111 participants (estimated)
Patient registry
No

Groups and cohorts

  • Progression

    There is at least one major coronary artery (left main artery, left anterior descending artery, left circumflex artery or the right coronary artery) had non-target lesions, and the coronary artery stenosis rate reached the progressive level on follow-up angiography.

  • Non-progression

    The rate of coronary stenosis of the non-target lesion did not reach progressive levels during the repeat angiography.

06

What researchers measure

Primary outcomes

  1. Correlation between emerging risk factors and progression of coronary non-target lesions.

    To calculate the change of non-target lesion stenosis rate , and get the correlation with homocysteine, lipoprotein(a) and so on by Logistic regression analysis

    Time frame: The estimated period of time over which the event is assessed up to 16 weeks, and from date of grouping until the date of first documented progression whichever came first, assessed up to 60 months.

Secondary outcomes

  1. Association of traditional risk factors and inflammation with the evolution of coronary non-target lesions

    To calculate the change of non-target lesion stenosis rate , and get the correlation with the basic information and inflammation of the participants by Logistic regression analysis

    Time frame: The estimated period of time over which the event is assessed up to 16 weeks, and from date of grouping until the date of first documented progression whichever came first, assessed up to 60 months.

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Nakachi T, Kosuge M, Hibi K, Ebina T, Hashiba K, Mitsuhashi T, Endo M, Umemura S, Kimura K. C-reactive protein elevation and rapid angiographic progression of nonculprit lesion in patients with non-ST-segment elevation acute coronary syndrome. Circ J. 2008 Dec;72(12):1953-9. doi: 10.1253/circj.cj-08-0185. Epub 2008 Oct 29. PubMed 18957790 ↗
  • Xin H, Gong HP, Cai SL, Ning XF, Liu S, Chen ZY, Lian ZX, Zhang R, Zhang QF, Kang WQ, Ge ZM. Elevated lipoprotein-associated phospholipase A2 is associated with progression of nonculprit lesions after percutaneous coronary intervention. Tohoku J Exp Med. 2013 Jun;230(2):97-102. doi: 10.1620/tjem.230.97. PubMed 23774398 ↗
  • Hartmann M, von Birgelen C, Mintz GS, Stoel MG, Eggebrecht H, Wieneke H, Fahy M, Neumann T, van der Palen J, Louwerenburg HW, Verhorst PM, Erbel R. Relation between lipoprotein(a) and fibrinogen and serial intravascular ultrasound plaque progression in left main coronary arteries. J Am Coll Cardiol. 2006 Aug 1;48(3):446-52. doi: 10.1016/j.jacc.2006.03.047. Epub 2006 Jul 12. PubMed 16875967 ↗
  • Boroumand MA, Rekabi V, Davoodi G, Amirzadegan A, Saadat S, Abbasi SH, Hamidian R, Poorgholi L. Correlation between lipoprotein(a) serum concentration and severity of coronary artery stenosis in an Iranian population according to Gensini score. Clin Biochem. 2008 Feb;41(3):117-20. doi: 10.1016/j.clinbiochem.2007.10.004. Epub 2007 Oct 16. PubMed 17976374 ↗
  • Montalescot G, Ankri A, Chadefaux-Vekemans B, Blacher J, Philippe F, Drobinski G, Benzidia R, Kamoun P, Thomas D. Plasma homocysteine and the extent of atherosclerosis in patients with coronary artery disease. Int J Cardiol. 1997 Aug 8;60(3):295-300. doi: 10.1016/s0167-5273(97)00099-5. PubMed 9261641 ↗
  • Ferraro S, Marano G, Biganzoli EM, Boracchi P, Bongo AS. Prognostic value of cystatin C in acute coronary syndromes: enhancer of atherosclerosis and promising therapeutic target. Clin Chem Lab Med. 2011 Sep;49(9):1397-404. doi: 10.1515/CCLM.2011.607. Epub 2011 May 24. PubMed 21605013 ↗
  • Authors/Task Force Members; ESC Committee for Practice Guidelines (CPG); ESC National Cardiac Societies. 2019 ESC/EAS guidelines for the management of dyslipidaemias: Lipid modification to reduce cardiovascular risk. Atherosclerosis. 2019 Nov;290:140-205. doi: 10.1016/j.atherosclerosis.2019.08.014. Epub 2019 Aug 31. No abstract available. Erratum In: Atherosclerosis. 2020 Jan;292:160-162. doi: 10.1016/j.atherosclerosis.2019.11.020. Atherosclerosis. 2020 Feb;294:80-82. doi: 10.1016/j.atherosclerosis.2019.12.004. PubMed 31591002 ↗
  • Zhang Y, Wu NQ, Li S, Zhu CG, Guo YL, Qing P, Gao Y, Li XL, Liu G, Dong Q, Li JJ. Non-HDL-C is a Better Predictor for the Severity of Coronary Atherosclerosis Compared with LDL-C. Heart Lung Circ. 2016 Oct;25(10):975-81. doi: 10.1016/j.hlc.2016.04.025. PubMed 27634241 ↗

Individual participant data

Plan to share: No — Individual participant data (IPD) utilized in this study were obtained from our hospital's healthcare big data cloud platform. In consideration of the data security and privacy protection for study participants, the sharing of this data with other researchers is currently restricted.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06248138
Lead sponsor
Mei Gao
Responsible party
Mei Gao (Clinical Professor, Qianfoshan Hospital) — Sponsor-investigator
First posted
Feb 8, 2024
Start date
Feb 1, 2024 (estimated)
Primary completion
Apr 1, 2024 (estimated)
Completion
Jun 1, 2024 (estimated)
Last update
Feb 8, 2024

Study contacts

zhongsu Wang, doctor
Contact
1760@sdhospital.com.cn
15969694663
mei Gao, doctor
study chair · The First Affiliated Hospital of Shandong First Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion