Coronary Hemodynamics by Coronary Angiography

Coronary Artery Disease Clinical Trial

— ESCARGOT  

Official title:

Estimation of Coronary Artery Hemodynamic Profiles Using Cineangiography Technique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04646278
• Other study ID #: B-2017-01-012-015
• Status: Completed
• Phase: N/A
• Start date: April 11, 2017
• Est. completion date: March 25, 2020

Study information

• Verified date: November 2020
• Source: KangWon National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 25, 2020
• Est. primary completion date: March 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Hyperemic stimuli
Hyperemic simuli of coronary flow by adenosine or nicorandil injection

Locations

Country	Name	City	State
Korea, Republic of	Kangwon National University Hospital	Chuncheon	Gangwon-do

Sponsors (2)

Lead Sponsor	Collaborator
KangWon National University Hospital	The Korean Society of Cardiology

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TIMI frame count	frame count between the beginning and end of contrast column head	Imediately after the procedure
Primary	Coronary Clearance Frame Count	frame count between the beginning and end of contrast column tail	Imediately after the procedure
Primary	Index of microcirculatory resistance	derived from distal coronary pressure by transit time	During the procedure
Secondary	Fractional flow reserve	measured by pressure wire	During the procedure
Secondary	Coronary flow reserve	measured by pressure wire by thermodilution technique	During the procedure