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Completed

NCT Number: NCT03690713

International Collaboration of Comprehensive Physiologic Assessment

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

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Key information

Conditions

Stable Angina Angina Pectoris Angina, Stable Angina, Unstable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Artery Disease Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Non-ST Elevated Myocardial Infarction Non-ST Elevation Myocardial Infarction Pain Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction ST-segment Elevation Myocardial Infarction Signs and Symptoms Unstable Angina Vascular Diseases

Study type

Observational

Primary location

Tokyo Medical and Dental University, Tokyo, Japan

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fractional flow reserve, coronary flow reserve, and index of microcirculatory resistance

Diagnostic 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).

Primary outcomes

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

    Time frame: 5 year

    Patient-oriented composite outcome

  2. 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

Secondary outcomes

  1. Cumulative incidence of any death

    Time frame: 5 year

    all-cause mortality

  2. Cumulative incidence of cardiac death

    Time frame: 5 year

    cardiac death

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 1, 2018
Registry last updated
Oct 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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