Clinical trial NCT04646278: Coronary Hemodynamics by Coronary Angiography
Official title: Estimation of Coronary Artery Hemodynamic Profiles Using Cineangiography Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
Index of microcirculatory resistance
TIMI frame count
Fractional flow reserve
Coronary flow reserve
Lead sponsor: KangWon National University Hospital
Sponsor class: OTHER
Collaborators: name: The Korean Society of Cardiology
First posted: 2020-11-27
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients who underwent coronary angiography and further hyperemic stimui
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: TIMI frame count
timeFrame: Imediately after the procedure
measure: Coronary Clearance Frame Count
timeFrame: Imediately after the procedure
measure: Index of microcirculatory resistance
timeFrame: During the procedure
Secondary outcomes:
measure: Fractional flow reserve
timeFrame: During the procedure
measure: Coronary flow reserve
timeFrame: During the procedure
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
state: Gangwon-do
Study officials:
affiliation: KangWon National University Hospital
name: Bong-Ki Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: