International Collaboration of Comprehensive Physiologic Assessment

September 28, 2018 updated by: Bon-Kwon Koo, Seoul National University Hospital

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1397

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Tokyo Medical and Dental University
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Samsung Medical Center
  • Spain
      • Madrid, Spain
        • Hospital Clinico San Carlos, Madrid, Spain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of a composite of any death, any myocardial infarction, or any ischemia-driven revascularization
Time Frame: 5 year
Patient-oriented composite outcome
5 year
Cumulative incidence of a composite of cardiac death, target-vessel related myocardial infarction, or target-vessel revascularization
Time Frame: 5 year
Vessel-oriented composite outcome
5 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of any death
Time Frame: 5 year
all-cause mortality
5 year
Cumulative incidence of cardiac death
Time Frame: 5 year
cardiac death
5 year
Cumulative incidence of myocardial infarction
Time Frame: 5 year
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
5 year
Cumulative incidence of ischemia-driven revascularization
Time Frame: 5 year
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
5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Samsung Medical Center
Ulsan University Hospital
Inje University
Keimyung University Dongsan Medical Center
Imperial College Healthcare NHS Trust
Hospital San Carlos, Madrid
Tokyo Medical and Dental University
Tsuchiura Kyodo General Hospital
Sungkyunkwan University

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

September 26, 2018

Study Registration Dates

First Submitted

September 26, 2018

First Submitted That Met QC Criteria

September 26, 2018

First Posted (Actual)

October 1, 2018

Study Record Updates

Last Update Posted (Actual)

October 2, 2018

Last Update Submitted That Met QC Criteria

September 28, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT186918690001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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