Clinical Trials Logo

Clinical Trial Summary

Investigating the diagnostic accuracy of online Ultrasonic Flow Ratio (UFR) assessment to identify hemodynamically significant coronary stenosis in patients with suspected ischemic heart disease using angiography-derived fractional flow reserve (FFR) as a reference standard.


Clinical Trial Description

This is a prospective, single-center, observational registry study of patients with suspected ischemic coronary artery disease. The purpose of this registry is to investigate the accuracy of online UFR assessment to identify hemodynamically significant coronary stenosis in patients with suspected ischemic heart disease using angiography-derived FFR as a reference standard. Study population and sample size calculation are based on the diagnostic performance of previous studies, where an accuracy of 92% was found for UFR. Investigators conservatively estimate the diagnostic accuracy of online UFR assessment as 90% for consecutively enrolled patient population, and with a test target value set as 78% at a two-side significance level of 0.05, statistical power as 90%. Considering incomplete FFR/UFR data of 10% at most, a total of 112 patients need to be enrolled. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05694065
Study type Observational
Source Ruijin Hospital
Contact Fenghua Ding, MD, PhD
Phone +86 21 64370045
Email ruijindfh@126.com
Status Not yet recruiting
Phase
Start date January 30, 2023
Completion date December 31, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT04562805 - Infinity-Swedeheart Registry Based Randomized Clinical Trial (R-RCT) N/A
Recruiting NCT05292079 - CAPTURER PMCF Study ( rEPIC04D )
Recruiting NCT05292105 - NC Xperience PMCF Study( rEPIC04B)
Recruiting NCT05292014 - ANGIOLITE PMCF Study ( rEPIC04F )
Recruiting NCT05292092 - Essential Pro PMCF Study ( rEPIC04E )
Recruiting NCT05292118 - Navitian PMCF Study ( rEPIC04C )
Completed NCT03076801 - Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease? N/A
Not yet recruiting NCT04153383 - Milrinone on Left Ventricular Diastolic Performance During Off-pump Coronary Artery Bypass Surgery
Recruiting NCT02729064 - Intraoperative Nasal Insulin Effect on Plasma and CSF Insulin Concentration and Blood Glucose Phase 1
Recruiting NCT02982434 - The New Pharmaceutical Composition Containing Botulinum Toxin to Treat Atrial Fibrillation Phase 2
Completed NCT02468401 - Prevention of Contrast Induced Nephropathy in Patients With Advanced Renal Dysfunction Undergoing Coronary Interventions N/A
Completed NCT02759406 - Evaluation of the Palmaz Mach-5 Grooved Bare Metal Coronary Stent System Versus the Palmaz Bare Metal Coronary Stent System in Patients With Symptomatic Ischemic Heart Disease: A Safety and Performance Study N/A
Recruiting NCT01681381 - Evaluate Safety And Effectiveness Of The Tivoli® DES and The Firebird2® DES For Treatment Coronary Revascularization N/A
Completed NCT01604213 - Effects of Vildagliptin/Metformin Combination on Markers of Atherosclerosis, Thrombosis, and Inflammation in Diabetics With Coronary Artery Disease Phase 4
Completed NCT01699802 - Influence of Inhaled Anaesthetics on Rebreathing of Carbon Dioxide When Using an Anaesthesia Gas Reflector (AnaConDa) N/A
Completed NCT01724567 - Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training N/A
Completed NCT01334268 - RESOLUTE China RCT N/A
Completed NCT02159235 - Heavy Metals, Angiogenesis Factors and Osteopontin in Coronary Artery Disease (CAD) N/A
Completed NCT00983632 - Selective Vagus Nerve Stimulation in Human N/A