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.
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
- Conditions the study is for
- Stable Angina, Unstable Angina, Non-ST Elevation Myocardial Infarction
- 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
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
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.
- Conditions
- Stable Angina, Unstable Angina, Non-ST Elevation Myocardial Infarction, ST-segment Elevation Myocardial Infarction
- 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 group | Role | What they receive |
|---|---|---|
| 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. 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.
Cumulative incidence of a composite of any death, any myocardial infarction, or any ischemia-driven revascularization
Patient-oriented composite outcome
Measured: 5 year
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)
Cumulative incidence of any death
all-cause mortality
Measured: 5 year
Cumulative incidence of cardiac death
cardiac death
Measured: 5 year
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
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.
- First posted1 Oct 2018
- Study start1 Jun 2018
- Primary completion1 Jun 2018
- Study completion26 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Medical Center, Tsuchiura Kyodo General Hospital, Hospital San Carlos, Madrid, Imperial College Healthcare NHS Trust, Tokyo Medical and Dental University, Sungkyunkwan University, Inje University, Keimyung University Dongsan Medical Center, Ulsan University Hospital
- Responsible party
- Principal investigator, Bon-Kwon Koo, Seoul National University Hospital
- Investigators
- Bon-Kwon Koo, MD, PhD, Study chair, Seoul National University HospitalJavier Escaned, MD, PhD, Study chair, Hospital Clinico San Carlos, Madrid, SpainTsunekazu Kakuta, MD, PhD, Study chair, Tokyo Medical and Dental University, Tokyo, JapanJoo Myung Lee, MD, MPH, PhD, Study chair, Samsung Medical Center, Seoul, Korea
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 33911143Lee 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 32725991Hamaya 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 32624458Hamaya 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 32506182Lee 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