NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs061180103

Registered date:28/03/2019

CT Perfusion-PET trial

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedischemic heart disease
Date of first enrollment05/07/2017
Target sample size80
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)necessity of two imaging modalities for assessment of myocardial ischemia

Outcome(s)

Primary Outcome1. rest/stress myocardial blood flow by CTP (MBF-CTP) & coronary flow reserve by CTP (CFR-CTP), rest/stress myocardial blood flow by PET (MBF-PET) & coronary flow reserve by PET (CFR-PET), 2. prognosis: all cause death, cardiac death, acute coronary syndrome, admission for ischemic heart disease, target lesion revascularization (TLR), target vessel revascularization (TVR)
Secondary Outcome1. angina scale (SAQ: Seattle Angina Questionnaire) 2. qualitative analysis by CTP & PET 3. evaluation of myocardial ischemia with other modalities: MR perfusion, SPECT, echo 4. quantitative flow ratio (QFR) by CTP 5. QCA 6. FFR, iFR 7. contrast medium, radiation dose

Key inclusion & exclusion criteria

Age minimum>= 40age old
Age maximum<= 85age old
GenderBoth
Include criteria1. patients with diagnosed or suspected coronary artery disease 2. patients who undergo cardiac CT and ammonia-PET
Exclude criteria1. clinically unstable patients (acute myocardial infarction, unstable angina, malignant arrhythmia, symptomatic heart failure: NYHA >class 2, aortic stenosis: >moderate) 2. known prior myocardial infarction 3. known anaphylactic reaction to iodinated contrast 4. bronchial asthma or uncontrolled hyperthyroidism 5. chronic kidney disease (Cre > 1.5 mg/dl) or hemodialysis 6. patients with chronic atrial fibrillation 7. patients with atrial-ventricular block (2 or 3 degree), sick sinus syndrome 8. pacemaker or internal defibrillator lead implantation 9. pregnancy or lactation 10. previous coronary intervention (within 6 months) 11. contraindication to be-ta blockers 12. previous coronary artery bypass grafting 13. patients who are considered inappropriate by a principal investigator or a member of this project

Related Information

Contact

Public contact
Name Teruyoshi Uetani
Address 454 Shitsukawa, Toon, Ehime Ehime Japan 791-0295
Telephone +81-89-960-5303
E-mail t.ue307@gmail.com
Affiliation Ehime University Hospital
Scientific contact
Name Osamu Yamaguchi
Address 454 Shitsukawa, Toon, Ehime Ehime Japan 791-0295
Telephone +81-89-960-5303
E-mail osamu7@gmail.com
Affiliation Ehime University Hospital