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NCT Number: NCT02208388

Prospective Evaluation of MyocaRdial PerFUSion ComputEd Tomography Trial

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

Recruiting

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Key information

Conditions

Coronary Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center, Seoul, Songpa-Gu, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

computed tomography perfusion guided treatment

Device

Fractional flow reserve guided treatment

Device

Primary outcomes

  1. Composite Events

    Time frame: 1 year

    All cause death, Myocardial infarction, Diseased-related unplanned hospitalization or stroke

Secondary outcomes

  1. All cause death

    Time frame: 5 year

    All cause death

  2. Myocardial infarction

    Time frame: 5 year

    Myocardial infarction

  3. Target vessel revascularization

    Time frame: 5 year

    Target vessel revascularization

  4. Stent thrombosis

    Time frame: 5 year

    Stent thrombosis

  5. Seattle Angina Questionnaire,EQ5D questionnaire

    Time frame: 5 year

    Quality of life score assessed by the EQ-5D-5L The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

    Higher score of EQ-5D and EQ VAS means the low quality of life. EQ-5D: the minimum and maximum values are 5 and 25 respectively. EQ VAS: the minimum and maximum values are 0 and 100 respectively.

    Seattle Angina Questionnaire The Seattle Angina Questionnaire (SAQ) is a vali- dated disease-specific instrument for assessing the health status of patients with coronary artery disease.

    SAQ scores can be aligned with clinical constructs (eg, scores on the SAQ angina frequency scale of 0-30 points indicate daily angina, 31-60 points indicate weekly angina, 61-99 points indicate monthly angina, and 100 points indicate no angina)

  6. Success of intervention

    Time frame: 5 year

    Defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death

  7. Cost effective analysis

    Time frame: 1 year

    Cost effective analysis

Study contacts

Contact information is provided by the study sponsor or research team.

Young-Hak Kim, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Young-Hak Kim, MD, PhD

Other

Registry information

Official study title

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

Acronym: PERFUSERCT

Important dates

Study start
2014
Primary completion
2028
Study completion
2028
First posted
Aug 5, 2014
Registry last updated
Apr 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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