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OpenTrials
Completed

NCT Number: NCT04426396

Diagnostic Performance of Fractional Flow Reserve Derived From Coronary CT Angiography

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FFR

Diagnostic Test

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

Other names: CT-FFR

Primary outcomes

  1. Sensitivity and specificity of CT-FFR compared to FFR

    Time frame: 1 day

Secondary outcomes

  1. Diagnostic accuracy and AUC of CT-FFR compared to FFR

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • Zhejiang Hospital

Registry information

Official study title

Coronary CT Angiography-Derived Fractional Flow Reserve for Functional Evaluation of Coronary Artery Disease

Acronym: ACCURATE-CT

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jun 11, 2020
Registry last updated
Mar 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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