International Collaboration of Comprehensive Physiologic Assessment

NCT03690713 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1397

Last updated 2018-10-02

No results posted yet for this study

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).

Conditions

  • Stable Angina
  • Unstable Angina
  • Non-ST Elevation Myocardial Infarction
  • ST-segment Elevation Myocardial Infarction

Interventions

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).

Sponsors & Collaborators

  • Samsung Medical Center

    collaborator OTHER
  • Tsuchiura Kyodo General Hospital

    collaborator OTHER
  • Hospital San Carlos, Madrid

    collaborator OTHER
  • Imperial College Healthcare NHS Trust

    collaborator OTHER
  • Tokyo Medical and Dental University

    collaborator OTHER
  • Sungkyunkwan University

    collaborator OTHER
  • Inje University

    collaborator OTHER
  • Keimyung University Dongsan Medical Center

    collaborator OTHER
  • Ulsan University Hospital

    collaborator OTHER
  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Bon-Kwon Koo, MD, PhD · Seoul National University Hospital

  • Javier Escaned, MD, PhD · Hospital Clinico San Carlos, Madrid, Spain

  • Tsunekazu Kakuta, MD, PhD · Tokyo Medical and Dental University, Tokyo, Japan

  • Joo Myung Lee, MD, MPH, PhD · Samsung Medical Center, Seoul, Korea

Eligibility

Sex
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2018-06-01
Completion
2018-09-26

Countries

  • Japan
  • South Korea
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03690713 on ClinicalTrials.gov