Phase III clinical trial to evaluate the diagnostic accuracy of QFR

JRCT ID: jRCT2032210032

Registered date:12/04/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Stable angina or stenosis after AMI
• Date of first enrollment: 25/05/2021
• Target sample size: 191
• Study type: Interventional
• Intervention(s): FFR will be measured during coronary angiography or coronary intervention in the patients who gave written consent. QFR will be measured by a certified user for all vessels for which FFR assessment is planed. Patients will be treated according to the results of angiography and FFR. QFR values should not be used to determine treatment strategy.

Outcome(s)

• Primary Outcome: Evaluate the diagnostic accuracy of QFR with FFR as gold standard, and compare the diagnostic accuracy of QFR with that of anatomical assessment by QCA.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Patients with stable angina or patients who undergo a secondary assessment of stenosis after AMI - 20 years of age or older
- Patients who can give written consent to the participation

Exclude criteria

- Patients who had myocardial infarction within 72 hours
- Patients with severe asthma or severe chronic obstructive pulmonary disease
- Patients with severe heart failure

Related Information

• Primary Sponsor: van Schaik-Yamamoto Yuko