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Stable AnginaNCT03690713

International Collaboration of Comprehensive Physiologic Assessment

An observational study of Stable Angina and Unstable Angina, run by Seoul National University Hospital at 4 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The current study evaluated prognostic implication of comprehensive physiologic assessment using fractional flow reserve, coronary flow reserve (CFR) and index of microcirculatory resistance (IMR). Read more about this study

Who is it for?
Any age
What is being tested?
Fractional flow reserve, coronary flow reserve, and index of microcirculatory resistance
Type of treatment
Injection or infusion
How many people
1,397 participants
Where
4 sitesin 3 countries
Study dates
1 Jun 2018to 26 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
  • Child, Adult, Older adult

Study population: patients who underwent clinically indicated invasive coronary angiography and measurements of FFR, CFR, and IMR for at least 1 coronary artery

Who may be able to join

  • patients who underwent clinically indicated invasive coronary angiography and measurements of FFR, CFR, and IMR for at least 1 coronary artery

Who cannot join

  • Patients with hemodynamic instability
  • left ventricular dysfunction
  • culprit vessel of acute coronary syndrome

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

South Korea2 sites

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

Japan1 site

  • Tokyo Medical and Dental University

    Tokyo

Other trials in Japan

Spain1 site

  • Hospital Clinico San Carlos, Madrid, Spain

    Madrid

Other trials in Spain

About this study

Official title: International Patient-level Pooled Analysis of Comprehensive Physiologic Assessment: Collaborating Project of Korea, Japan, and Spain

The current study evaluated prognostic implication of comprehensive physiologic assessment using fractional flow reserve, coronary flow reserve (CFR) and index of microcirculatory resistance (IMR).

Read the detailed description

The patient-level data was gathered from 3 nations (Korea, Japan, Spain). The total 1397 patients (1694 vessels) data was collected from 5 university hospitals in Korea (Seoul National University Hospital, Samsung Medical Centre, Inje University Ilsan Paik Hospital, Keimyung University Dongsan Medical Centre, and Ulsan University Hospital, Korea) and Tsuchiura Kyodo General Hospital, Ibaraki, Japan, and Hospital Clinico San Carlos, Madrid, Spain.

Standardized form of data collection sheet was used and all study adopted standardized definition of patient's baseline characteristics, clinical outcomes, and physiologic data. In case of acute coronary syndrome (unstable angina, non-ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction), only non-culprit vessel was included in the data.

Primary outcome is patient- and vessel-oriented composite outcome at 5 years.

Being tested
Fractional flow reserve, coronary flow reserve, and index of microcirculatory resistance
Keywords
fractional flow reserve, myocardial ischemia, coronary artery disease, coronary flow reserve, index of microcirculatory resistance, prognosis, percutaneous coronary intervention
Medical subject headings
Angina, Stable, Angina, Unstable, Non-ST Elevated Myocardial Infarction, ST Elevation Myocardial Infarction, Myocardial Ischemia, Coronary Artery Disease

What participants receive

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

  • Fractional flow reserve, coronary flow reserve, and index of microcirculatory resistanceDiagnostic test

    The pressure sensor was positioned at the distal segment of a target vessel, and intracoronary nitrate was administered before each physiologic measurement. To derive resting mean transit time (Tmn), a thermodilution curve was obtained by using 3 injections (3-4 mL each) of room-temperature saline. Hyperemic proximal aortic pressure (Pa), distal arterial pressure (Pd), and hyperemic Tmn were measured during sustained hyperemia. CFR was calculated as resting Tmn/hyperemic Tmn. FFR was calculated as the lowest average of 3 consecutive beats during hyperemia. The uncorrected IMR was calculated by Pd × Tmn during hyperaemia. All IMR values were corrected by Yong's formula (Pa × Tmn × ([1.35 × Pd/Pa] - 0.32).

Study groups in NCT03690713
Study groupRoleWhat they receive
Patient and Vessels underwent physiologic evaluationThe total 1397 patients (1694 vessels) which evaluated using pressure-temperature sensor wire and measured FFR, CFR, and IMR.
Receives: Diagnostic Test: Fractional flow reserve, coronary flow reserve, and index of microcirculatory resistance

What is being measured

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

  1. Cumulative incidence of a composite of any death, any myocardial infarction, or any ischemia-driven revascularization

    Patient-oriented composite outcome

    Measured: 5 year

  2. Cumulative incidence of a composite of cardiac death, target-vessel related myocardial infarction, or target-vessel revascularization

    Vessel-oriented composite outcome

    Measured: 5 year

Secondary outcomes (4)

  1. Cumulative incidence of any death

    all-cause mortality

    Measured: 5 year

  2. Cumulative incidence of cardiac death

    cardiac death

    Measured: 5 year

  3. Cumulative incidence of myocardial infarction

    MI was defined as elevated cardiac enzyme levels greater than the upper limit of the normal range with either ischemic symptoms or electrocardiography changes indicating ischemia after index procedure. Periprocedural MI was not included as a clinical outcome

    Measured: 5 year

  4. Cumulative incidence of ischemia-driven revascularization

    Ischemia-driven revascularization was defined as a revascularization procedure with at least one of the following: (1) recurrence of angina; (2) positive non-invasive test; and (3) positive invasive physiologic test

    Measured: 5 year

Timeline

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

  1. First posted1 Oct 2018
  2. Study start1 Jun 2018
  3. Primary completion1 Jun 2018
  4. Study completion26 Sep 2018

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
1,397 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03690713
Sponsor's protocol ID
NCT186918690001
Status last verified
Sep 2018
First submitted
26 Sep 2018
Last updated
2 Oct 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Anonymized patient level data will be made available by the corresponding author for reasonable requests. Consent was not obtained for data sharing but the presented data are anonymized and risk of identification is minimal.

Publications

  • Shin D, Lee JM, Lee SH, Hwang D, Choi KH, Kim HK, Doh JH, Nam CW, Shin ES, Hoshino M, Murai T, Yonetsu T, Mejia-Renteria H, Kakuta T, Escaned J, Koo BK. Non-randomized comparison between revascularization and deferral for intermediate coronary stenosis with abnormal fractional flow reserve and preserved coronary flow reserve. Sci Rep. 2021 Apr 28;11(1):9126. doi: 10.1038/s41598-021-88732-4.

    PubMed 33911143

  • Lee JM, Choi KH, Doh JH, Nam CW, Shin ES, Hoshino M, Murai T, Yonetsu T, Mejia-Renteria H, Kakuta T, Escaned J, Koo BK. Long-term Patient Prognostication by Coronary Flow Reserve and Index of Microcirculatory Resistance: International Registry of Comprehensive Physiologic Assessment. Korean Circ J. 2020 Oct;50(10):890-903. doi: 10.4070/kcj.2020.0083. Epub 2020 May 27.

    PubMed 32725991

  • Hamaya R, Lee JM, Hoshino M, Yonetsu T, Koo BK, Escaned J, Kakuta T; Collaborators. Clinical outcomes of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention By Coronary Flow Capacity Status in Stable Lesions. EuroIntervention. 2021 Jul 20;17(4):e301-e308. doi: 10.4244/EIJ-D-20-00401.

    PubMed 32624458

  • Hamaya R, Hoshino M, Yonetsu T, Lee JM, Koo BK, Escaned J, Kakuta T. Defining heterogeneity of epicardial functional stenosis with low coronary flow reserve by unsupervised machine learning. Heart Vessels. 2020 Nov;35(11):1527-1536. doi: 10.1007/s00380-020-01640-x. Epub 2020 Jun 6.

    PubMed 32506182

  • Lee SH, Lee JM, Park J, Choi KH, Hwang D, Doh JH, Nam CW, Shin ES, Hoshino M, Murai T, Yonetsu T, Mejia-Renteria H, Kakuta T, Escaned J; International Collaboration of Comprehensive Physiologic Assessment Investigators. Prognostic Implications of Resistive Reserve Ratio in Patients With Coronary Artery Disease. J Am Heart Assoc. 2020 Apr 21;9(8):e015846. doi: 10.1161/JAHA.119.015846. Epub 2020 Apr 18.

    PubMed 32306809

Questions about this trial

What is this clinical trial studying?

An observational study of Stable Angina and Unstable Angina, run by Seoul National University Hospital at 4 sites in 3 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 1 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: finished, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in South Korea, Japan, Spain. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Cumulative incidence of a composite of any death, any myocardial infarction, or any ischemia-driven revascularization (time frame: 5 year). The study lists 2 primary outcomes in all. 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 NCT03690713, which also lists 5 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 2 Oct 2018.

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