Korean NIRS-IVUS Multicenter Registry

Coronary Artery Disease With Myocardial Infarction Clinical Trial

Official title:

Korean Near-infrared Spectroscopy(NIRS)-Intravascular Ultrasound (IVUS) Multicenter Registry: a Comprehensive Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04619355
• Other study ID #: NIRS-IVUS in Korea
• Status: Recruiting
• Start date: January 1, 2010
• Est. completion date: May 1, 2027

Study information

• Verified date: April 2024
• Source: Korea University Anam Hospital
• Contact: Jung Joon Cha, MD,PhD
• Email: joonletter[@]hanmail.net
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Heart diseases known as the second cause of death in Koreans are coronary artery diseases such as angina and myocardial infarction. Coronary artery disease occurs when fat components, such as cholesterol, accumulate in the body. When these fat components are deposited in blood vessels, blood vessels' walls become thick, and the blood vessels narrow, which interferes with circulation. Without smooth circulation, the heart muscle does not function properly because the supply of oxygen and nutrient-rich blood, which is necessary for the heart to function normally, is not properly supplied. It leads to angina pectoris and chest pain and can cause myocardial infarction or even heart attack. Coronary artery disease in various aspects has a high mortality rate when it occurs in old age. The methods currently used for diagnosis and treatment are coronary angiography, percutaneous coronary intervention (PCI), and myocardial partial blood flow reserve history. There is a wide variety of tests (Fractional Flow Reserve, FFR), near-infrared spectroscopy intravascular ultrasound (NIRS-IVUS).

In addition to the various aspects and treatment methods of this disease, treatment is often difficult, so the clinical significance is great. In the case of PCI, one of the methods of examination and treatment, the National Cardiovascular Data Registry (NCDR) has been established to establish guidelines for improving patient prognosis after surgery in the United States. NCDR, which started with the American College of Cardiology (ACC) initiative, is currently in an indispensable position for establishing clinical practice guidelines such as monitoring treatment-related indicators, quality improvement (QI), and clinical research. In charge. Besides, in recent years, the use of new drugs or new devices (Post-Market Surveillance), real-time risk estimation, and personalized planning is increasing.

Research to analyze the prognosis of various aspects of coronary artery disease, tests, and procedures has been constantly conducted, but comprehensive studies that can be used to improve the overall treatment are considered to be insufficient. At this point, a comprehensive study is required to establish clinical guidelines and to develop them continuously.

In particular, the area that needs research is whether or not future events can be prevented using vascular imaging. Studies have shown that if lipids are actively treated with statins, the lipid component of atherosclerotic plaques can be significantly reduced in just a few weeks. Suggests. According to the results of a YELLOW (Reduction in Yellow Plaque by Aggressive Lipid-Lowering Therapy) study published in 2012 based on a near-infrared spectroscopy-vascular ultrasound analysis, the active treatment group of statins showed the lipid-core burden index compared to the standard treatment group. ) showed a significant decrease.

Accordingly, this study collects all comprehensive indicators such as test methods, test results, procedures, and treatment results for all patients undergoing near-infrared spectroscopy-vascular ultrasound treatment in Korea, including this institution, A comprehensive study of the disease registry related to the near-infrared spectroscopy-vascular ultrasound procedure is conducted to determine the type of disease, the number of affected vessels, and disease-related indicators.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: May 1, 2027
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• patient who underwent PCI using NIRS-IVUS

• Subjects who agreed to the study plan and clinical follow-up plan, voluntarily decided to participate in this clinical study and agreed in writing to the subject consent form

Exclusion Criteria:

• Subjects who cannot perform cardiovascular angiography due to severe symptoms of heart failure

• Subjects whose expected life expectancy is within 1 year due to the accompanying disease

• Women of childbearing age who plan to become pregnant within the study period

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease With Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Device:
• NIRS-IVUS
Near-infrared spectroscopy-intravascular ultrasound can be implemented in parallel with intravascular ultrasound and provides important information for predicting prognosis by measuring the lipid component of atherosclerotic plaques.

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac death	Cardiac death	1 Day
Secondary	MACE	Composite of cardiac death, MI, unstable angina or progressive angina either requiring revascularization or with rapid lesion progression	1 Day
Secondary	Death	Any cause of death	1 Day
Secondary	Stent thrombosis	Stent thrombosis	1 Day
Secondary	Stroke	Stroke	1 Day