Diagnostic Performance of Fractional Flow Reserve Derived From Coronary CT Angiography (ACCURATE-CT)

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Zhejiang University

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Diagnostic Test: FFR

Study type

Observational

Funder types

Other

Identifiers

NCT04426396
2019-375

Details and patient eligibility

About

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.

Enrollment

339 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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