Coronary Hemodynamics by Coronary Angiography | NCT04646278

Studies
Coronary Hemodynamics by Coronary Angiography

NCT04646278

Sponsor

KangWon National University Hospital

Status

Completed

Last Update Posted

Nov 27, 2020Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Coronary Artery Disease

Interventions

Hyperemic stimuli

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 11, 2017Actual

Primary Completion Date

Mar 25, 2020Actual

Completion Date

Mar 25, 2020Actual

First Submitted Date

Nov 4, 2020

First Submission Date that Met QC Criteria

Nov 22, 2020

First Posted Date

Nov 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2020

Last Update Posted Date

Nov 27, 2020Actual

Name	Class
The Korean Society of Cardiology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hyperemic stimuli	Experimental	Hyperemic stimuli of coronary flow by adenosine or nicorandil injection	Drug: Hyperemic stimuli

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hyperemic stimuli	Drug	Hyperemic simuli of coronary flow by adenosine or nicorandil injection	Hyperemic stimuli

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bong-Ki Lee, MD, PhD	KangWon National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kangwon National University Hospital		Chuncheon	Gangwon-do	24289	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Could be shared after necessary discussions

Types

Study Protocol

Time Frame

after publication

Access Criteria

Investigator who I permitted

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

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Browse Branches

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