Ischemic Heart Disease
Conditions
Brief 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.
Detailed description
1. Study overview 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. 2. 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. 3. Participant enrollment was completed in November 2024; the study is currently in the follow-up phase with ongoing data collection and analysis.
Interventions
None listed
Sponsors
Ruijin Hospital
School of Biomedical Engineering, Shanghai Jiao Tong University
Erasmus Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject must be ≥ 18 years * Patients suspected with ischemic heart disease * ≥ 1 diseased vessel with angiographic percent diameter stenosis between 40% and 80% in a vessel ≥ 2.5mm by visual estimation * Target vessels are limited to major epicardial coronary arteries (left anterior descending artery \[LAD\], left circumflex artery \[LCX\], right coronary artery \[RCA\])
Exclusion criteria
* Patients with previous coronary artery bypass grafting (CABG) * Myocardial infarction within 72h of coronary angiography * Allergy to the contrast agent or adenosine * Left main coronary artery stenosis ≥ 50% * Target vessel with in-stent restenosis * Target vessel with severe tortuosity or angulation * 100% occlusion of target vessel * Target vessel spasm or injury * Target vessel with severe myocardial bridge * Target vessel with severe thrombosis * Intravascular ultrasound (IVUS) pullback fails to cover the complete target lesion * Presence of false lumen at target vessel based on IVUS * A serum creatinine level \>150 umol/l, or a glomerular filtration rate \< 45 ml/kg/1.73 m\^2 * Heart failure * Ineligible for diagnostic intervention (IVUS or FFR examination)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Accuracy of Onsite UFR | baseline | UFR was computed as the pressure ratio across a coronary stenosis, using FFR ≤0.80 as the reference standard for hemodynamically significant stenosis. The diagnostic performance of onsite UFR was assessed by the area under the receiver operating characteristic (ROC) curve analysis, with diagnostic accuracy defined as the percentage of all correctly classified cases (true positives and true negatives) in the total population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of Onsite UFR | baseline | The diagnostic performance of onsite UFR was assessed by ROC curve analysis, using an FFR ≤0.80 as the reference standard. Sensitivity was defined as the percentage of true positives correctly identified by UFR. |
| Specificity of Onsite UFR | baseline | The diagnostic performance of onsite UFR was assessed by ROC curve analysis, using an FFR ≤0.80 as the reference standard. Specificity was defined as the percentage of true negatives correctly identified by UFR. |
| Sensitivity of Minimal Lumen Area (MLA) | baseline | The diagnostic performance of MLA was assessed by ROC curve analysis, using an FFR ≤0.80 as the reference standard. Sensitivity was defined as the percentage of true positives correctly identified by the prespecified MLA cutoff value. |
| Specificity of MLA | baseline | The diagnostic performance of MLA was assessed by ROC curve analysis, using an FFR ≤0.80 as the reference standard. Specificity was defined as the percentage of true negatives correctly identified by the prespecified MLA cutoff value. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORFenghua Ding, MD, PhD
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Functional Assessment in Patients With Suspected Ischemic Heart Disease Onsite UFR and FFR Assessment in Patients with Suspected Ischemic Heart Disease | 106 |
| Total | 106 |
Baseline characteristics
| Characteristic | Functional Assessment in Patients With Suspected Ischemic Heart Disease |
|---|---|
| Age, Continuous | 68.5 years |
| Body Mass Index (BMI) | 24.6 Kg/m^2 STANDARD_DEVIATION 3.2 |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Diagnostic Accuracy of Onsite UFR
UFR was computed as the pressure ratio across a coronary stenosis, using FFR ≤0.80 as the reference standard for hemodynamically significant stenosis. The diagnostic performance of onsite UFR was assessed by the area under the receiver operating characteristic (ROC) curve analysis, with diagnostic accuracy defined as the percentage of all correctly classified cases (true positives and true negatives) in the total population.
Time frame: baseline
Population: Six participants were excluded according to the predefined exclusion criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Functional Assessment in Patients With Suspected Ischemic Heart Disease | Diagnostic Accuracy of Onsite UFR | 94 percentage of correctly classified cases |
Secondary
Sensitivity of Minimal Lumen Area (MLA)
The diagnostic performance of MLA was assessed by ROC curve analysis, using an FFR ≤0.80 as the reference standard. Sensitivity was defined as the percentage of true positives correctly identified by the prespecified MLA cutoff value.
Time frame: baseline
Population: Six participants were excluded according to the predefined exclusion criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Functional Assessment in Patients With Suspected Ischemic Heart Disease | Sensitivity of Minimal Lumen Area (MLA) | 47 percentage of true positives |
Secondary
Sensitivity of Onsite UFR
The diagnostic performance of onsite UFR was assessed by ROC curve analysis, using an FFR ≤0.80 as the reference standard. Sensitivity was defined as the percentage of true positives correctly identified by UFR.
Time frame: baseline
Population: Six participants were excluded according to the predefined exclusion criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Functional Assessment in Patients With Suspected Ischemic Heart Disease | Sensitivity of Onsite UFR | 88 percentage of true positives |
Secondary
Specificity of MLA
The diagnostic performance of MLA was assessed by ROC curve analysis, using an FFR ≤0.80 as the reference standard. Specificity was defined as the percentage of true negatives correctly identified by the prespecified MLA cutoff value.
Time frame: baseline
Population: Six participants were excluded according to the predefined exclusion criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Functional Assessment in Patients With Suspected Ischemic Heart Disease | Specificity of MLA | 84 percentage of true negatives |
Secondary
Specificity of Onsite UFR
The diagnostic performance of onsite UFR was assessed by ROC curve analysis, using an FFR ≤0.80 as the reference standard. Specificity was defined as the percentage of true negatives correctly identified by UFR.
Time frame: baseline
Population: Six participants were excluded according to the predefined exclusion criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Functional Assessment in Patients With Suspected Ischemic Heart Disease | Specificity of Onsite UFR | 97 percentage of true negatives |