Accuracy of quantification of myocardial blood flow by Dynamic Stress Perfusion CT: verification with 15O-H2O PET

JRCT ID: jRCTs042220045

Registered date:15/07/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Known or suspected chronic coronary artery disease
• Date of first enrollment: 09/01/2024
• Target sample size: 47
• Study type: Interventional
• Intervention(s): Myocardial perfusion CT examinations for clinical purposes are currently performed using a Siemens CT system (SOMATOM FORCE) at Mie University Hospital. This is due to the fact that there have been many studies suggesting the clinical usefulness of myocardial perfusion CT using SOMATOM FORCE. The CT system of GE healthcare (Revolution CT), which was introduced to our hospital in March 2019, has a larger detector size in the z-axis direction compared to the SOMATOM FORCE, which may be more useful for cardiac perfusion imaging. However, for the aforementioned reasons, Revolution CT has not been used as a routine myocardial perfusion CT examination in our hospital. If a myocardial perfusion CT scan is performed with Revolution CT, it is possible that the results will not be exactly the same as if the SOMATOM FORCE were used. Since this study was a prospective study using Revolution CT, it was determined that it could be considered an intervention.

Outcome(s)

• Primary Outcome: The purpose of the study in the pilot group was to examine whether there were systematic errors (Pearson's correlation coefficient greater than 0.5) in myocardial blood flow measurements (segment-based and patient-based) between stress CTP and 15O-H2O myocardial perfusion PET, and to compute the correction equation if the systemic error is found. The validity of the correction equation will be evaluated using the intraclass correlation coefficient in the validation group.

Secondary Outcome

1. Regional and global hyperemic myocardial blood flow and myocardial blood flow reserve (ratio of blood flow during vasodilator stress to at rest) determined from cardiac CT are compared with myocardial blood flow reserve determined from 15O-H2O myocardial blood flow PET.
2. In patients undergoing invasive coronary angiography, the diagnostic value of myocardial blood flow measured with cardiac CT will be evaluated for detecting significant coronary stenosis and significant abnormalities in Fractional Flow Reserve (FFR) and Instantaneous Wave-Free Ratio (iFR).
3. Evaluation of morphological features of the distribution of myocardial ischemic regions on perfusion CT.

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1) Patients with known or suspected chronic coronary artery disease who are clinically indicated to be evaluated by myocardial perfusion imaging
2) Age 50-75
3) Patients who have given written consent to perform 15O-H2O myocardial perfusion PET and to participate in the study

Exclude criteria

1) Contraindications to adenosine triphosphate and iodine contrast media
2) Claustrophobia that makes it difficult to perform cardiac PET and CT examinations
3) Difficulty with breath holding required for the cardiac PET and CT examinations
4) Poor general condition
5) Women with known or possible pregnancy
6) Inappropriate research participants (judged by the researchers in this study)
7) Patients who experienced a cardiovascular event, underwent revascularization, or had a change or addition of medication between cardiac CT and myocardial perfusion PET examinations
8) Reduced renal function (determined as eGFR less than 0.45 mL/min/1.73m2 within 1 month before the examinations)
9) A past history of myocardial infarction

Related Information

• Primary Sponsor: Ichikawa Yasutaka
• Source(s) of Monetary Support: GE Healthcare Japan