Prospective Evaluation of MyocaRdial PerFUSion ComputEd T... | NCT02208388

Studies
Prospective Evaluation of MyocaRdial PerFUSion ComputEd Tomography Trial

NCT02208388

Sponsor

Young-Hak Kim, MD, PhD

Status

Recruiting

Last Update Posted

Apr 5, 2023Actual

Enrollment

1,000Estimated

Phase

Not Applicable

Conditions

Coronary Disease

Interventions

computed tomography perfusion guided treatment
Fractional flow reserve guided treatment

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

Apr 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 12, 2014Actual

Primary Completion Date

Mar 5, 2028Estimated

Completion Date

Mar 5, 2028Estimated

First Submitted Date

Jul 31, 2014

First Submission Date that Met QC Criteria

Aug 3, 2014

First Posted Date

Aug 5, 2014Estimated

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

Apr 4, 2023

Last Update Posted Date

Apr 5, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

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

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Computed tomography perfusion	Experimental	Patients with Computed tomography perfusion	Device: computed tomography perfusion guided treatment
Fractional flow reserve	Active Comparator	Patients with Fractional flow reserve	Device: Fractional flow reserve guided treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
computed tomography perfusion guided treatment	Device		Computed tomography perfusion
Fractional flow reserve guided treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite Events	All cause death, Myocardial infarction, Diseased-related unplanned hospitalization or stroke	1 year

Secondary Outcomes

Measure	Description	Time Frame
All cause death	All cause death	5 year
Myocardial infarction	Myocardial infarction	5 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 20 and more
Diagnosed angina or angina equivalent symptom or positive exercise treadmill test
Patients with intermediate- or high-risk probability of CAD defined by Diamond and Forester
70 % stenosis or more in coronary CTA
Willing to provide informed, written consent

Exclusion Criteria:

Requirement for surgical procedure
Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support
Recent STEMI (<5 days)
Non STEMI, if the cardiac troponin is not stable or starting to decline
Left ventricular ejection fraction <30%
Life expectancy <2 years
Impaired renal function with an effective glomerular filtration rate less than 30mL/min/1.73 ㎡ or creatinine more than 2.0 mg/dL
Undergoing evaluation for organ transplantation
Participation or planned participation in another cardiovascular clinical trial
Pregnancy
Inability to take dual antiplatelet therapy for six months
Previous CABG
Left main disease requiring revascularization
Any target lesion with in-stent restenosis
NYHA class 3 or 4a
Severe and persistent angina with severe limitation in everyday living activities (Canadian Cardiovascular Society grading Class IV)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Young-Hak Kim, MD	Contact			mdyhkim@amc.seoul.kr

Overall Officials

Name	Affiliation	Role
Byoung-Wook Choi, MD	Severance Hospital, Yonsei University College of Medicine	Principal Investigator
Young-Hak Kim, MD	Asan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center	Recruiting	Seoul	Songpa-Gu		South Korea

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases