Factors Related to the Progression of Non-target Coronary Lesions

February 7, 2024 updated by: Mei Gao

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

1111

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mei Gao

Investigators

  • Study Chair: mei Gao, doctor, The First Affiliated Hospital Of Shandong First Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

January 9, 2024

First Submitted That Met QC Criteria

February 7, 2024

First Posted (Actual)

February 8, 2024

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YXLL-KY-2023(155)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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