Assessment of Fractional Flow Reserve by Intravascular Ultrasound

JRCT ID: jRCTs032180330

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Stable coronary artery disease
• Date of first enrollment: 17/04/2017
• Target sample size: 31
• Study type: Interventional
• Intervention(s): Anatomical assessment and measuring intensity of blood speckle using intravascular ultrasound, and physiological assessment during percutaneous coronary intervention

Outcome(s)

• Primary Outcome: Correlation between delta intensity of blood speckle and fractional flow reserve under basal condition and hyperemia
• Secondary Outcome: Diagnostic accuracy of delta intensity of blood speckle for fractional flow reserve less than or equal to 0.80 under basal condition and hyperemia

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both
• Include criteria: Patients with stable coronary artery disease who are scheduled to undergo percutaneous coronary intervention

Exclude criteria

1. Patients with hemodialysis
2. Patients who are inhaled drugs or theophylline products for bronchial asthema
3. Patients with left main trunk lesion or stenosis >50% at the distal to the target lesion
4. Patients with chronic total obstruction
5. Patients with severe heart failure (ejection fraction <30% or NYHA >class 3)
6. Patients with prior coronary artery bypass grafting

Related Information

• Primary Sponsor: Kitahara Hideki
• Secondary ID(s): UMIN No. 000026325