Clinical trial NCT06248138: Factors Related to the Progression of Non-target Coronary Lesions
Official title: Factors Related to the Progression of Non-target Coronary Lesions
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coronary Stenosis
Keywords: Coronary heart disease
Atherosclerotic progression
Non-target coronary lesion
Quantitative flow ratio
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 1111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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. 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.

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.

Eligibility criteria: 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:

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.

Primary outcomes:
measure: Correlation between emerging risk factors and progression of coronary non-target lesions.
timeFrame: 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:
measure: Association of traditional risk factors and inflammation with the evolution of coronary non-target lesions
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
affiliation: Shandong First Medical University
name: mei Gao, doctor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.