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Coronary Artery Disease With Myocardial InfarctionNCT04619355

Korean NIRS-IVUS Multicenter Registry

An observational study of Coronary Artery Disease With Myocardial Infarction, run by Korea University Anam Hospital at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
NIRS-IVUS
Type of treatment
Medical device
How many people
1,500 participants
Where
1 siteSouth Korea
Study dates
1 Jan 2010to 1 May 2027
How long will I take part?
3 Years
Phase
Observational
Are there results?
Not yet: the study is under way

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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Since this study includes all inpatients who have undergone near-infrared spectroscopy-intravascular ultrasonography, the target number of subjects is not limited, and all patients suitable for the study will be enrolled. After the end of the study, the total number of institutional procedures will be finalized to calculate the number of enrolled subjects.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jung Joon Cha, MD,PhD contact

joonletter@hanmail.net

South Korea1 site, 1 recruiting
  • Korea University Anam Hospital

    Seoul

    Jung Joon Cha, MD, PhD, joonletter@hanmail.net

    Recruiting

Other trials in South Korea

About this study

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

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.

Read more

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.

Being tested
NIRS-IVUS
Keywords
NIRS, IVUS
Medical subject headings
Coronary Artery Disease, Autosomal Dominant, 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NIRS-IVUSDevice

    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.

Study groups in NCT04619355
Study groupRoleWhat they receive
TVC K-RegistryNot described
Receives: Device: NIRS-IVUS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiac death

    Cardiac death

    Measured: 1 Day

Secondary outcomes (4)
  1. MACE

    Composite of cardiac death, MI, unstable angina or progressive angina either requiring revascularization or with rapid lesion progression

    Measured: 1 Day

  2. Death

    Any cause of death

    Measured: 1 Day

  3. Stent thrombosis

    Stent thrombosis

    Measured: 1 Day

  4. Stroke

    Stroke

    Measured: 1 Day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2020
  2. Study start1 Jan 2010
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
1,500 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04619355
Sponsor's protocol ID
NIRS-IVUS in Korea
Status last verified
Apr 2024
First submitted
2 Nov 2020
Last updated
4 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease With Myocardial Infarction, run by Korea University Anam Hospital at 1 site in South Korea.

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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jung Joon Cha, MD,PhD (joonletter@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiac death (time frame: 1 Day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 4 Apr 2024.

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