Functional Diagnostic Accuracy of Ultrasonic Flow Ratio in Assessment of Left Main Coronary Artery Stenosis

NCT06053944 | Unknown

• 1 other identifier: 2022-12M-C&T-B-043
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, observational, single-center study. The main purpose of this study is to evaluate the diagnostic accuracy of offline computational ultrasonic flow ratio (UFR) in predicting functionally significant left main (LM) coronary stenosis 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 120 patients with intermediated left main 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 left main coronary artery stenosis will be analyzed.

Conditions

Left Main Coronary Artery Disease

Keywords

intravascular ultrasound; ultrasonic flow ratio; fractional flow reserve

Outcome Measures

Primary Outcomes (2)

• Diagnostic accuracy of UFR in predicting functionally significant left main coronary stenosis, using FFR as the reference standard

  Diagnostic accuracy is defined as UFFR (≤0.80 or \>0.80) to identify hemodynamically-significant left main coronary stenosis with FFR (≤0.80 or \>0.80) as the reference standard.

  Immediately after the procedure

• Sensitivity and specificity of UFR in predicting functionally significant left main coronary stenosis, using FFR as the reference standard

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

  Immediately after the procedure

Secondary Outcomes (2)

• Comparison of sensitivity and specificity of UFR and IVUS-derived minimal lumen area (MLA) in predicting functionally significant left main coronary stenosis, using FFR as the reference standard

  Immediately after the procedure

• The AUC of UFR for left main 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

UFR is a novel IVUS-derived modality for fast computation of FFR without pressure wires and adenosine.

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 left main 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
• Proximal LAD diffuse lesions (diameter stenosis \> 50%)
• IVUS pullback not covering the entire lesion
• Severe myocardial bridge in the interrogated vessel

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Select A State, 100037, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Jie Qian

  Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

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
• Target Duration: 5 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2023
• First Posted: September 26, 2023
• Study Start: October 18, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 22, 2024

Record last verified: 2023-09

Locations

CN (1)