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OpenTrials
Completed

NCT Number: NCT04646278

Coronary Hemodynamics by Coronary Angiography

Study for developing techniques to evaluate coronary artery hemodynamic profiles by conventional angiography without more dedicated measuring devices.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kangwon National University Hospital

Chuncheon, Gangwon-do, 24289, South Korea

About this study

  • Methods: Compare TIMI frame count, coronary clearance frame count in baseline/hyperemic coronary angiography with FFR, CFR, IMR and derive correlation, receiver-operating characteristic curve to find new tools estimating coronary hemodynamics by conventional angiography only.

A TIMI frame count is measured by counting the angiographic image cine frames during a head of radiocontrast column runs from the entry of left anterior descending artery (LAD) to the distal end.

A coronary clearance frame count is measured by counting the angiographic image cine frames during a tail of radiocontrast column runs from the entry of LAD to the distal end.

Baseline angiography is performed without any stimulation and hyperemic angiography is performed after intracoronary injection of adenosine 300ug or nicorandiol 2mg.

Inclusion criteria

  • Patient who underwent physiologic study using a pressure wire for intermediate coronary lesion after coronary angiography

Exclusion criteria

  • ST elevation myocardial infarction
  • Cardiogenic shock
  • Congestive heart failure with pulmonary edema
  • LVEF < 30%
  • Previous history of coronary revascularization
  • Chronic total occlusion
  • 3 vessel disease
  • Target lesion at distal segments or branches

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient who underwent physiologic study using a pressure wire for intermediate coronary lesion after coronary angiography

Exclusion criteria

  • ST elevation myocardial infarction
  • Cardiogenic shock
  • Congestive heart failure with pulmonary edema
  • LVEF < 30%
  • Previous history of coronary revascularization
  • Chronic total occlusion
  • 3 vessel disease
  • Target lesion at distal segments or branches

Treatment and study plan

Hyperemic stimuli

Drug

Hyperemic simuli of coronary flow by adenosine or nicorandil injection

Other names: Hyperemia

Primary outcomes

  1. TIMI frame count

    Time frame: Imediately after the procedure

    frame count between the beginning and end of contrast column head

  2. Coronary Clearance Frame Count

    Time frame: Imediately after the procedure

    frame count between the beginning and end of contrast column tail

  3. Index of microcirculatory resistance

    Time frame: During the procedure

    derived from distal coronary pressure by transit time

Secondary outcomes

  1. Fractional flow reserve

    Time frame: During the procedure

    measured by pressure wire

  2. Coronary flow reserve

    Time frame: During the procedure

    measured by pressure wire by thermodilution technique

Sponsors and collaborators

Lead sponsor

KangWon National University Hospital

Other

Collaborators

  • The Korean Society of Cardiology

Registry information

Official study title

Estimation of Coronary Artery Hemodynamic Profiles Using Cineangiography Technique

Acronym: ESCARGOT

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 27, 2020
Registry last updated
Nov 27, 2020

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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