Coronary StenosisNCT06248138
Factors Related to the Progression of Non-target Coronary Lesions
An observational study of Coronary Stenosis, run by Mei Gao.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Stenosis
- How many people
- 1,111 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 1 Jun 2024
- 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: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
- Exclusion criteria included uncontrolled severe arrhythmia and severe hepatic and renal dysfunction.
- Patients with tumor or other autoimmune diseases were excluded from the study.
- Incomplete clinical information, biochemical test information, coronary angiography data, and imaging data were considered as exclusion factors.
Trial locations and contacts
No sites are listed yet.
About this study
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:
- 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.
- 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.
- Conditions
- Coronary Stenosis
- Keywords
- Coronary heart disease, Atherosclerotic progression, Non-target coronary lesion, Quantitative flow ratio
- Medical subject headings
- Coronary Stenosis, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Feb 2024 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Coronary StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mei Gao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mei Gao, Qianfoshan Hospital
- Investigators
- mei Gao, doctor, Study chair, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248138
- Sponsor's protocol ID
- YXLL-KY-2023(155)
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2024
- Last updated
- 8 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 18957790Xin 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 23774398Hartmann 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 16875967Boroumand 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 17976374Montalescot 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 9261641Ferraro 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 21605013Authors/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.
PubMed 31591002Zhang 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Related to the Progression of Non-target Coronary Lesions
- ClinicalTrials.gov ID
- NCT06248138
- Acronym / sponsor ID
- YXLL-KY-2023(155)
- Conditions
- Coronary Stenosis
- Keywords
- Coronary heart disease, Atherosclerotic progression, Non-target coronary lesion, Quantitative flow ratio
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,111 participants (estimated)
- Lead sponsor
- Mei GaoUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
- Exclusion criteria included uncontrolled severe arrhythmia and severe hepatic and renal dysfunction.
- Patients with tumor or other autoimmune diseases were excluded from the study.
- Incomplete clinical information, biochemical test information, coronary angiography data, and imaging data were considered as exclusion factors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between emerging risk factors and progression of coronary non-target lesions.
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.
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
1 secondary outcome
Association of traditional risk factors and inflammation with the evolution of coronary non-target lesions
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Background: PubMed 18957790Nakachi 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.
- Background: PubMed 23774398Xin 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.
- Background: PubMed 16875967Hartmann 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.
- Background: PubMed 17976374Boroumand 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.
- Background: PubMed 9261641Montalescot 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.
- Background: PubMed 21605013Ferraro 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.
- Results publication: PubMed 31591002Authors/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.
- Results publication: PubMed 27634241Zhang 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mei Gao, doctor study chair
Shandong First Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Stenosis, run by Mei Gao.
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 3 inclusion and 5 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 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 zhongsu Wang, doctor (15969694663, 1760@sdhospital.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between emerging risk factors and progression of coronary non-target lesions. (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.). 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 NCT06248138, which also lists 8 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 8 Feb 2024.