Diagnostic Performance of Fractional Flow Reserve Derived From Coronary CT Angiography

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

339 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-15

Study Completion Date

2022-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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FFR

FFR measured by pressure wire, CT-FFR computed by coronary CT angiography

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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CT-FFR

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No