Diagnostic Performance of Fractional Flow Reserve Derived From Coronary CT Angiography

NCT04426396 | Completed

• 1 other identifier: 2019-375
• Study Type: observational
• Target: 339
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of CT-FFR compared to FFR

  1 day

Secondary Outcomes (1)

• Diagnostic accuracy and AUC of CT-FFR compared to FFR

  1 day

Interventions

FFR DIAGNOSTIC_TEST

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

Also known as: CT-FFR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with stable angina or unstable angina who need selective surgery referred to coronary angiography and physiological evaluation.

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Zhejiang Hospital: collaborator

Study Sites (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Related Publications (1)

• Li C, Hu Y, Jiang J, Dong L, Sun Y, Tang L, Du C, Yin D, Jiang W, Leng X, Jiang F, Pan Y, Jiang X, Zhou Z, Koo BK, Xiang J, Wang J; ACCURATE-CT Investigators. Diagnostic Performance of Fractional Flow Reserve Derived From Coronary CT Angiography: The ACCURATE-CT Study. JACC Cardiovasc Interv. 2024 Sep 9;17(17):1980-1992. doi: 10.1016/j.jcin.2024.06.027. Epub 2024 Aug 21.

  PMID: 39177553 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2020
• First Posted: June 11, 2020
• Study Start: April 15, 2020
• Primary Completion: December 31, 2021
• Study Completion: May 31, 2022
• Last Updated: March 8, 2023

Record last verified: 2022-05

Locations

CN (1)