NCT03690713

Brief 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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,397

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 1, 2018

Completed
Last Updated

October 2, 2018

Status Verified

September 1, 2018

Enrollment Period

Same day

First QC Date

September 26, 2018

Last Update Submit

September 28, 2018

Conditions

Stable AnginaUnstable AnginaNon-ST Elevation Myocardial InfarctionST-segment Elevation Myocardial Infarction

Keywords

fractional flow reservemyocardial ischemiacoronary artery diseasecoronary flow reserveindex of microcirculatory resistanceprognosispercutaneous coronary intervention

Outcome Measures

Primary Outcomes (2)

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

    Patient-oriented composite outcome

    5 year

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

    Vessel-oriented composite outcome

    5 year

Secondary Outcomes (4)

  • Cumulative incidence of any death

    5 year

  • Cumulative incidence of cardiac death

    5 year

  • Cumulative incidence of myocardial infarction

    5 year

  • Cumulative incidence of ischemia-driven revascularization

    5 year

Study Arms (1)

Patient and Vessels underwent physiologic evaluation

The total 1397 patients (1694 vessels) which evaluated using pressure-temperature sensor wire and measured FFR, CFR, and IMR.

Diagnostic Test: Fractional flow reserve, coronary flow reserve, and index of microcirculatory resistance

Interventions

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).

Patient and Vessels underwent physiologic evaluation

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Tokyo Medical and Dental University

Tokyo, Japan

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Hospital Clinico San Carlos, Madrid, Spain

Madrid, Spain

Location

Related Publications (5)

  • 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.

    PMID: 33911143DERIVED

  • 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.

    PMID: 32725991DERIVED

  • 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.

    PMID: 32624458DERIVED

  • 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.

    PMID: 32506182DERIVED

  • 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.

    PMID: 32306809DERIVED

MeSH Terms

Conditions

Angina, StableAngina, UnstableNon-ST Elevated Myocardial InfarctionST Elevation Myocardial InfarctionMyocardial IschemiaCoronary Artery Disease

Condition Hierarchy (Ancestors)

Angina PectorisHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMyocardial InfarctionInfarctionIschemiaPathologic ProcessesNecrosisCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Bon-Kwon Koo, MD, PhD

    Seoul National University Hospital

    STUDY CHAIR

  • Javier Escaned, MD, PhD

    Hospital Clinico San Carlos, Madrid, Spain

    STUDY CHAIR

  • Tsunekazu Kakuta, MD, PhD

    Tokyo Medical and Dental University, Tokyo, Japan

    STUDY CHAIR

  • Joo Myung Lee, MD, MPH, PhD

    Samsung Medical Center, Seoul, Korea

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 26, 2018

First Posted

October 1, 2018

Study Start

June 1, 2018

Primary Completion

June 1, 2018

Study Completion

September 26, 2018

Last Updated

October 2, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

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.

Locations

ES(1)KR(2)JP(1)