CT Perfusion-PET trial

JRCT ID: jRCTs061180103

Registered date:28/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: ischemic heart disease
• Date of first enrollment: 05/07/2017
• Target sample size: 80
• Study type: Interventional
• Intervention(s): necessity of two imaging modalities for assessment of myocardial ischemia

Outcome(s)

Primary Outcome

1. 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 Outcome

1. 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
• Gender: Both

Include criteria

1. patients with diagnosed or suspected coronary artery disease
2. patients who undergo cardiac CT and ammonia-PET

Exclude criteria

1. 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

• Primary Sponsor: Yamaguchi Osamu
• Source(s) of Monetary Support: Bayer Yakuhin, Ltd,FUJIFILM Toyama Chemical Co., Ltd.