Factors Related to the Progression of Non-target Coronary Lesions

NCT06248138 | Unknown

• 1 other identifier: YXLL-KY-2023(155)
• Study Type: observational
• Target: 1,111
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 2.Non-progress groups: On repeat angiography, the rate of coronary stenosis did not reach progressive levels.

Conditions

Coronary Stenosis

Keywords

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

Outcome Measures

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

  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

  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.

Study Arms (2)

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.

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Participants had a documented medical history of various heart diseases, including congenital heart disease, pulmonary heart disease, valvular disease, cardiomyopathy, etc.
• Angiography or serum collection was conducted within 7 days following the onset of acute myocardial infarction.
• Patients with tumor or other autoimmune diseases were excluded from the study.

Sponsors & Collaborators

• Mei Gao: lead

Related Publications (8)

• 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.

  PMID: 18957790 BACKGROUND

• 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.

  PMID: 23774398 BACKGROUND

• 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.

  PMID: 16875967 BACKGROUND

• 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.

  PMID: 17976374 BACKGROUND

• 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.

  PMID: 9261641 BACKGROUND

• 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.

  PMID: 21605013 BACKGROUND

• 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.

  PMID: 31591002 RESULT

• 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.

  PMID: 27634241 RESULT

MeSH Terms

Conditions

Coronary Stenosis; Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• mei Gao, doctor

  Shandong First Medical University

  STUDY CHAIR

Central Study Contacts

zhongsu Wang, doctor

CONTACT

15969694663; 1760@sdhospital.com.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: February 8, 2024
• Study Start: February 1, 2024
• Primary Completion: April 1, 2024
• Study Completion: June 1, 2024
• Last Updated: February 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share