Clinical trial NCT02792075: Prognosis of Coronary Stenosis Based on Intracoronary Imaging; A Multicenter, Prospective Observational Study
Official title: Prognosis of Coronary Stenosis Based on Intracoronary Imaging; A Multicenter, Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Keywords: Coronary Stenosis
Intracoronary Imaging
VH-IVUS
OCT
NIRS
gray scale IVUS
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2016-06-07
Enrollment: 4000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with intracoronary imaging

Brief summary: The purpose of this study is to evaluate the prognosis of coronary stenosis based on intracoronary Imaging.


Eligibility criteria: Inclusion Criteria:

* Patients with intracoronary imaging
* Written consent

Exclusion Criteria:

* Severe calcification and/or severe tortuosity
* Lesion with previous bypass graft surgery (CABG)
* Left ventricular ejection fraction less than 30 %
* Coronary spasm
* Life expectancy less than 2 years
* Pregnancy or breast-feeding

Primary outcomes:
measure: Target Vessel Failure
timeFrame: 2 years
Secondary outcomes:
measure: All-cause death
timeFrame: 5 years
measure: Cardiac death
timeFrame: 5 years
measure: Number of myocardial infarction events
timeFrame: 5 years
measure: Composite event of death or myocardial infarction
timeFrame: 5 years
measure: Composite event of cardiac death or myocardial infarction
timeFrame: 5 years
measure: Target Vessel revascularization
timeFrame: 5 years
measure: Target Lesion revascularization
timeFrame: 5 years
measure: Number of stent thrombosis events
timeFrame: 5 years
measure: Number of stroke
timeFrame: 5 years
measure: Procedural success
timeFrame: 7 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Cheonan
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Ilsan
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Jeju
country: Korea, Republic of
facility: Jeju national university hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang university hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
Study officials:
References: