Status:
COMPLETED
Diagnostic Performance of Fractional Flow Reserve Derived From Coronary CT Angiography
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
Zhejiang Hospital
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Brief Summary
This is a blind evaluation, self-control, multicenter clinical trial designed to determine the diagnostic performance of CT-FFR from coronary computed tomographic angiography (CCTA), as compared to CC...
Eligibility Criteria
Inclusion
- Age≥ 18 years old;
- Subjects with clinical need and consent for coronary angiography;
- Can provide the results of coronary CT angiography within 60 days prior to ICA or agree to undergo coronary CT angiography;
- The subjects knew about the experiment and signed the informed consent voluntarily.
Exclusion
- Patients who have had percutaneous coronary intervention (PCI);
- Patients who had CABG;
- Acute coronary syndrome, such as acute ST segment elevation;
- Severe tachycardia or arrhythmia;
- Patients with severe hepatorenal insufficiency;
- Patients with congenital heart disease, implanted pacemaker or defibrillator, artificial heart valve;
- Failure to perform invasive FFR examination or obtain FFR value due to various reasons;
- Allergic to β - blockers, nitrates and adenosine, sick sinus syndrome, long QT syndrome, severe hypotension, severe asthma, severe COPD or COPD;
- Persistent or significant clinical instability, including acute chest pain (sudden onset), cardiogenic shock, blood pressure instability (systolic blood pressure \< 90mmHg) and severe congestive heart failure (according to the heart classification of the New York Heart Association, grade III or IV of cardiac function) or acute pulmonary edema;
- The CTA images of coronary artery showed that the stenosis rate was less than 30% or greater than 90%, or the diameter of diseased segment was less than 2.0mm;
- CT-FFR can not be calculated because of the quality of CTA image;
- Known pregnant and lactating women;
- Having participated in other clinical trials within 3 months;
- Other situations that the researchers judged were not suitable for inclusion.
Key Trial Info
Start Date :
April 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
339 Patients enrolled
Trial Details
Trial ID
NCT04426396
Start Date
April 15 2020
End Date
May 31 2022
Last Update
March 8 2023
Active Locations (1)
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1
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009