Factors Related to the Progression of Non-target Coronary Lesions

Not yet recruiting

• Conditions: Coronary Stenosis

• Registration Number: NCT06248138
• Lead Sponsor: Mei Gao

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.

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-09
• Study Start: 2024-02-01
• Study First Submitted QC: 2024-02-07
• Last Update Submitted: 2024-02-07
• Study First Posted: 2024-02-08
• Last Update Posted: 2024-02-08
• Primary Completion: 2024-04-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1111

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between emerging risk factors and progression 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.	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

Secondary Outcome Measures

Name	Time	Method
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.	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