Coronary Hemodynamics by Coronary Angiography (ESCARGOT)

Estimation of Coronary Artery Hemodynamic Profiles Using Cineangiography Technique

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Hyperemic stimuli

Detailed Description

* 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

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangwon-do
    • Chuncheon, Gangwon-do, Korea, Republic of, 24289
      • Kangwon National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Hyperemic stimuli; Hyperemic stimuli of coronary flow by adenosine or nicorandil injection	Drug: Hyperemic stimuli; Hyperemic simuli of coronary flow by adenosine or nicorandil injection; Other Names: Hyperemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TIMI frame count	frame count between the beginning and end of contrast column head	Imediately after the procedure
Coronary Clearance Frame Count	frame count between the beginning and end of contrast column tail	Imediately after the procedure
Index of microcirculatory resistance	derived from distal coronary pressure by transit time	During the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fractional flow reserve	measured by pressure wire	During the procedure
Coronary flow reserve	measured by pressure wire by thermodilution technique	During the procedure

Collaborators and Investigators

• Sponsor: KangWon National University Hospital
• Collaborators: The Korean Society of Cardiology

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 11, 2017
• Primary Completion (ACTUAL): March 25, 2020
• Study Completion (ACTUAL): March 25, 2020

Study Registration Dates

• First Submitted: November 4, 2020
• First Submitted That Met QC Criteria: November 22, 2020
• First Posted (ACTUAL): November 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 27, 2020
• Last Update Submitted That Met QC Criteria: November 22, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: coronary artery disease; Fractional flow reserve; Coronary flow reserve; Index of microcirculatory resistance; TIMI frame count
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: B-2017-01-012-015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Could be shared after necessary discussions
• IPD Sharing Time Frame: after publication
• IPD Sharing Access Criteria: Investigator who I permitted
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No