AzTrials
AzTrials

Multivessel Coronary Artery DiseaseNCT01621438

Clinical Implication of 3-vessel Fractional Flow Reserve (FFR)

An observational study of Multivessel Coronary Artery Disease, run by Seoul National University Hospital at 20 sites in 5 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This study will evaluate the influence of total atherosclerotic burden assessed by 3-vessel fractional flow reserve (FFR) on the clinical outcomes of the patients with multi-vessel disease. Read more about this study

Who is it for?
Any age
Conditions the study is for
Multivessel Coronary Artery Disease
How many people
1,136 participants
Where
20 sitesin 5 countries
Study dates
May 2012to Sep 2018
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: The patients with 3-vessel intermediate coronary artery disease (visually 30~70% stenosis in coronary angiogram) whose FFR was measured at all 3-vessels due to their own clinical needs.

Who may be able to join

  • Subject must be at least 18 years of age.
  • Subject must have stenosis (>30% by visual estimate) in all 3-epicardial coronary arteries.
  • FFR should be measured at all 3-vessels at the end of a procedure.

Who cannot join

  • Depressed left ventricular systolic function (ejection fraction < 35%)
  • ST-elevation myocardial infarction within 72 hours,
  • Prior coronary artery bypass graft surgery
  • Creatinine level >= 2.0mg/dL or dependence on dialysis
  • Abnormal final myocardial flow (TIMI flow < 3)
  • Planned bypass surgery
  • Failed FFR measurement
  • Failed intended revascularization

Trial locations and contacts

20 sites in 5 countries.

20 sites in 5 countries

China6 sites

  • Fuwai hospital

    Beijing

  • Guandong general hospital

    Guandong

  • Queen Mary Hospital, The University of Hong Kong

    Hong Kong

  • United Christian Hospital

    Hong Kong

  • Nanjing 1st hospital

    Nanjing

  • Zhejiang No 2 hospital

    Zhejiang

Other trials in China

Japan6 sites

  • Gifu heart center

    Gifu

  • Kokura memorial hospital

    Kitakyushu

  • 2nd Red Cross hospital

    Kyoto

  • Aichi Medical university hospital

    Nagakute

  • Tokyo medical college hospital

    Tokyo

  • Wakayama medical university

    Wakayama

Other trials in Japan

South Korea6 sites

  • Keimyung University Dongsan medical center

    Daegu

  • Inje university Ilsan Paik hospital

    Ilsan

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital, Seoul, Korea

    Seoul

  • Ajou university hospital

    Suwon

  • Ulsan university hospital

    Ulsan

Other trials in South Korea

Singapore1 site

  • National University Heart center

    Singapore

Other trials in Singapore

Taiwan1 site

  • National Taiwan University hospital

    Taipei

Other trials in Taiwan

About this study

Official title: Influence of Total Atherosclerotic Burden Assessed by 3-vessel Fractional Flow Reserve (FFR) on the Clinical Outcomes of the Patients With Multi-vessel Disease

This study will evaluate the influence of total atherosclerotic burden assessed by 3-vessel fractional flow reserve (FFR) on the clinical outcomes of the patients with multi-vessel disease. For this purpose, the clinical data of the patients with 3-vessel intermediate coronary artery disease, whose FFR was measured at all 3-vessels due to their own clinical needs, will be analyzed.

Read the detailed description

Primary Analysis The Primary Analysis will be performed after 2-year follow-up data will be completed.

Pre-specified Subgroup Analysis

The pre-specified subgroup analysis will perform after 1-year follow-up data will be completed according to the following subjects:

  • Concordant and discordant results between FFR and angiographic stenosis severity (patients and lesions with pre-PCI FFR will be analyzed.).
  • Association between total atherosclerotic burden and total ischemic burden, coronary CT angiography substudy (after 2-year follow-up will be completed).
  • Validation of total ischemic burden (sum of 3 vessel FFR) with Duke score, measured by treadmill test.
  • Comparison of clinical outcomes of deferred lesions according to pre-PCI FFR levels (Pre-PCI FFR <0.75, 0.75-0.80, and >0.80).
  • Comparison of clinical outcomes of deferred lesions according to iFR and FFR values ⑥ Prognosis of functional complete revascularization versus incomplete revascularization
Keywords
coronary artery, atherosclerosis, angina pectoris
Medical subject headings
Atherosclerosis, Angina Pectoris

What is being measured

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

  1. The rate of the composite of major adverse cardiac events (MACE: cardiac death, myocardial infarction, revascularization) at 2 years per 3-vessel FFR

    Measured: 2 years after FFR measurement

Timeline

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

  1. First posted18 Jun 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionMar 2015
  4. Study completionSep 2018 (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
1,136 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01621438
Sponsor's protocol ID
H-1203-087-402
Status last verified
Aug 2017
First submitted
7 Jun 2012
Last updated
25 Aug 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Lee JM, Lee SH, Hwang D, Rhee TM, Choi KH, Kim J, Park J, Kim HY, Jung HW, Cho YK, Yoon HJ, Song YB, Hahn JY, Nam CW, Shin ES, Doh JH, Hur SH, Koo BK. Long-Term Clinical Outcomes of Nonhyperemic Pressure Ratios: Resting Full-Cycle Ratio, Diastolic Pressure Ratio, and Instantaneous Wave-Free Ratio. J Am Heart Assoc. 2020 Sep 15;9(18):e016818. doi: 10.1161/JAHA.120.016818. Epub 2020 Sep 11.

    PubMed 32914672

  • Lee JM, Choi KH, Koo BK, Park J, Kim J, Hwang D, Rhee TM, Kim HY, Jung HW, Kim KJ, Yoshiaki K, Shin ES, Doh JH, Chang HJ, Cho YK, Yoon HJ, Nam CW, Hur SH, Wang J, Chen S, Kuramitsu S, Tanaka N, Matsuo H, Akasaka T. Prognostic Implications of Plaque Characteristics and Stenosis Severity in Patients With Coronary Artery Disease. J Am Coll Cardiol. 2019 May 21;73(19):2413-2424. doi: 10.1016/j.jacc.2019.02.060.

    PubMed 31097161

  • Kim CH, Koo BK, Lee JM, Shin ES, Park J, Choi KH, Hwang D, Rhee TM, Zhang J, Choi YJ, Lee SY, Choi JH, Doh JH, Nam CW, Wang J, Chen S, Kuramitsu S, Tanaka N, Matsuo H, Akasaka T. Influence of Sex on Relationship Between Total Anatomical and Physiologic Disease Burdens and Their Prognostic Implications in Patients With Coronary Artery Disease. J Am Heart Assoc. 2019 Mar 5;8(5):e011002. doi: 10.1161/JAHA.118.011002.

    PubMed 30813812

  • Lee JM, Choi KH, Park J, Hwang D, Rhee TM, Kim J, Park J, Kim HY, Jung HW, Cho YK, Yoon HJ, Song YB, Hahn JY, Nam CW, Shin ES, Doh JH, Hur SH, Koo BK. Physiological and Clinical Assessment of Resting Physiological Indexes. Circulation. 2019 Feb 12;139(7):889-900. doi: 10.1161/CIRCULATIONAHA.118.037021.

    PubMed 30586749

  • Park J, Lee JM, Koo BK, Shin ES, Nam CW, Doh JH, Hwang D, Zhang J, Hu X, Wang J, Ye F, Chen S, Yang J, Chen J, Tanaka N, Yokoi H, Matsuo H, Takashima H, Shiono Y, Akasaka T. Clinical Relevance of Functionally Insignificant Moderate Coronary Artery Stenosis Assessed by 3-Vessel Fractional Flow Reserve Measurement. J Am Heart Assoc. 2018 Feb 15;7(4):e008055. doi: 10.1161/JAHA.117.008055.

    PubMed 29449274

  • Choi KH, Lee JM, Koo BK, Nam CW, Shin ES, Doh JH, Rhee TM, Hwang D, Park J, Zhang J, Kim KJ, Hu X, Wang J, Ye F, Chen S, Yang J, Chen J, Tanaka N, Yokoi H, Matsuo H, Takashima H, Shiono Y, Akasaka T. Prognostic Implication of Functional Incomplete Revascularization and Residual Functional SYNTAX Score in Patients With Coronary Artery Disease. JACC Cardiovasc Interv. 2018 Feb 12;11(3):237-245. doi: 10.1016/j.jcin.2017.09.009. Epub 2018 Jan 17.

    PubMed 29361444

  • Kobayashi Y, Lee JM, Fearon WF, Lee JH, Nishi T, Choi DH, Zimmermann FM, Jung JH, Lee HJ, Doh JH, Nam CW, Shin ES, Koo BK. Three-Vessel Assessment of Coronary Microvascular Dysfunction in Patients With Clinical Suspicion of Ischemia: Prospective Observational Study With the Index of Microcirculatory Resistance. Circ Cardiovasc Interv. 2017 Nov;10(11):e005445. doi: 10.1161/CIRCINTERVENTIONS.117.005445.

    PubMed 29146670

  • Lee JM, Koo BK, Shin ES, Nam CW, Doh JH, Hu X, Ye F, Chen S, Yang J, Chen J, Tanaka N, Yokoi H, Matsuo H, Takashima H, Shiono Y, Hwang D, Park J, Kim KJ, Akasaka T, Wang J. Clinical Outcomes of Deferred Lesions With Angiographically Insignificant Stenosis But Low Fractional Flow Reserve. J Am Heart Assoc. 2017 Aug 22;6(8):e006071. doi: 10.1161/JAHA.117.006071.

    PubMed 28862970

  • Lee JM, Kim CH, Koo BK, Hwang D, Park J, Zhang J, Tong Y, Jeon KH, Bang JI, Suh M, Paeng JC, Cheon GJ, Na SH, Ahn JM, Park SJ, Kim HS. Integrated Myocardial Perfusion Imaging Diagnostics Improve Detection of Functionally Significant Coronary Artery Stenosis by 13N-ammonia Positron Emission Tomography. Circ Cardiovasc Imaging. 2016 Sep;9(9):e004768. doi: 10.1161/CIRCIMAGING.116.004768.

    PubMed 27609817

Questions about this trial

What is this clinical trial studying?

An observational study of Multivessel Coronary Artery Disease, run by Seoul National University Hospital at 20 sites in 5 countries.

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 8 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 25 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in China, Japan, South Korea, Singapore, Taiwan. 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?

Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of the composite of major adverse cardiac events (MACE: cardiac death, myocardial infarction, revascularization) at 2 years per 3-vessel FFR (time frame: 2 years after FFR measurement). 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 NCT01621438, which also lists 9 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 25 Aug 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in