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Coronary Hemodynamics by Coronary Angiography (ESCARGOT)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Hyperemic stimuli
Sponsored by
KangWon National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring coronary artery disease, Index of microcirculatory resistance, TIMI frame count, Fractional flow reserve, Coronary flow reserve

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kangwon National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hyperemic stimuli

Arm Description

Hyperemic stimuli of coronary flow by adenosine or nicorandil injection

Outcomes

Primary Outcome Measures

TIMI frame count
frame count between the beginning and end of contrast column head
Coronary Clearance Frame Count
frame count between the beginning and end of contrast column tail
Index of microcirculatory resistance
derived from distal coronary pressure by transit time

Secondary Outcome Measures

Fractional flow reserve
measured by pressure wire
Coronary flow reserve
measured by pressure wire by thermodilution technique

Full Information

First Posted
November 4, 2020
Last Updated
November 22, 2020
Sponsor
KangWon National University Hospital
Collaborators
The Korean Society of Cardiology
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1. Study Identification

Unique Protocol Identification Number
NCT04646278
Brief Title
Coronary Hemodynamics by Coronary Angiography
Acronym
ESCARGOT
Official Title
Estimation of Coronary Artery Hemodynamic Profiles Using Cineangiography Technique
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 11, 2017 (Actual)
Primary Completion Date
March 25, 2020 (Actual)
Study Completion Date
March 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KangWon National University Hospital
Collaborators
The Korean Society of Cardiology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary artery disease, Index of microcirculatory resistance, TIMI frame count, Fractional flow reserve, Coronary flow reserve

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients who underwent coronary angiography and further hyperemic stimui
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyperemic stimuli
Arm Type
Experimental
Arm Description
Hyperemic stimuli of coronary flow by adenosine or nicorandil injection
Intervention Type
Drug
Intervention Name(s)
Hyperemic stimuli
Other Intervention Name(s)
Hyperemia
Intervention Description
Hyperemic simuli of coronary flow by adenosine or nicorandil injection
Primary Outcome Measure Information:
Title
TIMI frame count
Description
frame count between the beginning and end of contrast column head
Time Frame
Imediately after the procedure
Title
Coronary Clearance Frame Count
Description
frame count between the beginning and end of contrast column tail
Time Frame
Imediately after the procedure
Title
Index of microcirculatory resistance
Description
derived from distal coronary pressure by transit time
Time Frame
During the procedure
Secondary Outcome Measure Information:
Title
Fractional flow reserve
Description
measured by pressure wire
Time Frame
During the procedure
Title
Coronary flow reserve
Description
measured by pressure wire by thermodilution technique
Time Frame
During the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bong-Ki Lee, MD, PhD
Organizational Affiliation
KangWon National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kangwon National University Hospital
City
Chuncheon
State/Province
Gangwon-do
ZIP/Postal Code
24289
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Could be shared after necessary discussions
IPD Sharing Time Frame
after publication
IPD Sharing Access Criteria
Investigator who I permitted

Learn more about this trial

Coronary Hemodynamics by Coronary Angiography

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