RecruitingNot ApplicableNCT02208388

Prospective Evaluation of MyocaRdial PerFUSion ComputEd Tomography Trial

Prospective Evaluation of MyocaRdial PerFUSion ComputEd Tomography Trial: Ischemia-guided Revascularization Using Perfusion Coronary CT vs. Fractional Flow Reserve


Sponsor

Young-Hak Kim, MD, PhD

Enrollment

1,000 participants

Start Date

Aug 12, 2014

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate safety and effectiveness of CTP(computed tomography perfusion) guided revascularization vs FFR(Fractional flow reserve) guided revascularization


Eligibility

Min Age: 20 Years

Inclusion Criteria5

  • 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
  • % stenosis or more in coronary CTA
  • Willing to provide informed, written consent

Exclusion Criteria16

  • 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)

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Interventions

DEVICEcomputed tomography perfusion guided treatment
DEVICEFractional flow reserve guided treatment

Locations(7)

Asan Medical Center

Seoul, Songpa-Gu, South Korea

Hallym University Sacred Heart Hospital

Anyang, South Korea

Gangwon National Univ. Hospital

Chuncheon, South Korea

Keimyung University Dongsan Medical Center

Daegu, South Korea

Pusan National University Hospital

Pusan, South Korea

Pusan National University Yangsan Hospital

Pusan, South Korea

Severance Hospital

Seoul, South Korea

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NCT02208388


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