Coronary Artery Disease
Conditions
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 CCTA alone, for non-invasive diagnosis of the presence of a hemodynamically significant coronary stenosis, using invasive fractional flow reserve (FFR) as the reference standard.
Interventions
DIAGNOSTIC_TESTFFR
FFR measured by pressure wire, CT-FFR computed by coronary CT angiography
Sponsors
Zhejiang Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of CT-FFR compared to FFR | 1 day |
Secondary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy and AUC of CT-FFR compared to FFR | 1 day |
Countries
China
Outcome results
None listed