Functional Diagnostic Accuracy of Ultrasonic Flow Ratio in Assessment of Coronary Artery Lesions

NCT06052670 | Unknown

• 1 other identifier: 2023-GSP-GG-4
• Study Type: observational
• Target: 408
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, single-center study. The primary purpose of this study is to evaluate the sensitivity and specificity of offline computational ultrasonic flow ratio (UFR) with conventional pressure wire-based fractional flow reserve (FFR) as the standard reference. The study will be conducted in Fuwai Hospital, and a total of 408 patients with coronary vessel diameter stenosis ≥30% and ≤80% are planned to be recruited. Participants who meet the inclusion criteria and do not meet the exclusion criteria will undergo intravascular ultrasound (IVUS) followed by FFR examination. IVUS imaging will be sent to an independent core laboratory for UFR calculation. UFR analyses were performed offline in a blinded fashion without awareness of FFR measurement. Using FFR≤0.80 as the gold standard, the sensitivity and specificity of UFR in the functional significance of coronary artery stenosis will be analyzed.

Conditions

Coronary Artery Stenosis

Keywords

intravascular ultrasound; ultrasonic flow ratio; fractional flow reserve

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of UFR in predicting functionally significant coronary stenosis at the patient level, using FFR as the reference standard

  Sensitivity is defined as the proportion of UFR ≤ 0.80 in patients with hemodynamically-significant stenosis as measured by FFR (FFR ≤ 0.80); specificity is defined as the proportion of UFR \> 0.80 in patients without hemodynamically-significant stenosis as measured by FFR (FFR \> 0.80).

  Immediately after the procedure

Secondary Outcomes (3)

• Sensitivity and specificity of UFR in predicting functionally significant coronary stenosis at the vessel level, using FFR as the reference standard

  Immediately after the procedure

• Diagnostic accuracy of UFR in predicting functionally significant coronary stenosis at the patient level, using FFR as the reference standard

  Immediately after the procedure

• The AUC of UFR for coronary stenosis with FFR as the gold standard

  Immediately after the procedure

Interventions

fractional flow reserve (FFR); ultrasonic flow ratio (UFR); intravascular ultrasound (IVUS) DIAGNOSTIC_TEST

pressure wire-based fractional flow reserve (FFR); intravascular ultrasound (IVUS)-based ultrasonic flow ratio (UFR)

Eligibility Criteria

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

Study Population

Patients ≥ 18 years of age who will be admitted for coronary angiography and had an indication for FFR measurement at the FuWai Hospital, Beijing, China, due to stable angina or unstable angina will be consecutively enrolled.

You may qualify if:

• Stable angina pectoris, unstable angina pectoris, or after the acute phase of myocardial infarction
• Age ≥18 years
• Written informed consent
• Intermediated coronary lesions (diameter stenosis of 30%-80% by visual estimation from coronary angiography)

You may not qualify if:

• Ineligible for diagnostic IVUS or FFR examination
• Prior coronary artery bypass grafting of the interrogated vessels
• Myocardial infarction within 72 h of coronary angiography
• Severe heart failure
• Serum creatinine levels \>150 umol/L, or glomerular filtration rates \<45 ml/kg/1.73 m2
• Allergy to the contrast agent or adenosine
• Life expectancy \< 2 years
• IVUS pullback not covering the entire lesion
• Severe myocardial bridge in the interrogated vessel

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Jie Qian, MD

CONTACT

+8613601396650; qianjfw@163.com

Cheng Yang, MD

CONTACT

+8619801116690; yangcheng_fw@163.com

Study Design

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

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 25, 2023
• Study Start: September 20, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 25, 2023

Record last verified: 2023-09