Clinical trial NCT04426396: Diagnostic Performance of Fractional Flow Reserve Derived From Coronary CT Angiography
Official title: Coronary CT Angiography-Derived Fractional Flow Reserve for Functional Evaluation of Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Zhejiang Hospital
First posted: 2020-06-11
Enrollment: 339
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with stable angina or unstable angina who need selective surgery referred to coronary angiography and physiological evaluation.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity and specificity of CT-FFR compared to FFR
timeFrame: 1 day
Secondary outcomes:
measure: Diagnostic accuracy and AUC of CT-FFR compared to FFR
timeFrame: 1 day
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: