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Recruiting NCT02792075

Prognosis of Coronary Stenosis Based on Intracoronary Imaging; A Multicenter, Prospective Observational Study

Observational Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 5-year Follow-up.
Who it may be relevant to
Registry conditions: Coronary Artery Disease. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

  • Other 5-year Follow-up

Primary outcome measures

  • Target Vessel Failure [Time frame: 2 years]
Secondary outcome measures (10)
  • All-cause death [Time frame: 5 years]
  • Cardiac death [Time frame: 5 years]
  • Number of myocardial infarction events [Time frame: 5 years]
  • Composite event of death or myocardial infarction [Time frame: 5 years]
  • Composite event of cardiac death or myocardial infarction [Time frame: 5 years]
  • Target Vessel revascularization [Time frame: 5 years]
  • Target Lesion revascularization [Time frame: 5 years]
  • Number of stent thrombosis events [Time frame: 5 years]
  • Number of stroke [Time frame: 5 years]
  • Procedural success [Time frame: 7 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 15 centers
  • Asan Medical Center — Seoul
  • Inje University Busan Paik Hospital — Busan
  • Soon Chun Hyang University Hospital Cheonan — Cheonan
  • Keimyung University Dongsan Medical Center — Daegu
  • Chungnam National University Hospital — Daejeon
  • Inje University Ilsan Paik Hospital — Ilsan
  • Gachon University Gil Hospital — Incheon
  • Jeju national university hospital — Jeju City
  • … and 7 more centers

Identifiers

NCT: NCT02792075 · AMCCV2016-09

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗