coronary heart disease
Conditions
Interventions
Gold Standard:Coronary flow reserve fraction measured by guidewire
Index test:Optical coherence tomography derived fractional flow fraction(FFR-OCT) measured by using the coronary artery OCT quantitative flow fraction calculation software based on optical coherence
Sponsors
The second hospital of Jilin university
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 ; 2. Participants with stable or unstable angina pectoris; 3. Researchers believe that it is necessary and feasible to undergo angiography, and the results of the angiography need to be further diagnosed using OCT imaging and FFR measurement, then PCI if necessary; 4. Able to understand and voluntarily sign the informed consent form, and complete the observation as required.
Exclusion criteria
Exclusion criteria: 1. Participants with abnormal coagulation function tests that have clinical significance; 2. Participants with severe hemodynamic disorders or shock; 3. Those who have experienced acute myocardial infarction within the past week; 4. Having severe heart failure symptoms (NYHA class III or above) or left ventricular ejection fraction (LVEF) <30%; 5. Renal insufficiency (serum creatinine greater than 200µmol/L); 6. Participants who are not suitable for coronary angiography; 7. Those diagnosed with coronary artery spasm; 8. Diagnosed with chronic total occlusion of the coronary artery; 9. Severe calcification or tortuous lesions; 10. in stent restenosis ; 11. Those with a history of allergy to contrast agents or adenosine; 12. Pregnant or lactating women; 13. Participants in other clinical trials that have not yet reached the primary endpoint; 14. Researchers believe that participants who are not suitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Accuracy;Negative Predictive Value;Negative predictive value;Positive likelihood ratio;Negative likelihood ratio;AUC of the ROC curve;Correlation between FFROCT (test device) and reference FFR;Agreement between FFROCT (test device) and reference FFR;Device handling performance;Adverse event rate;Device success rate; | — |
Countries
China
Contacts
Public ContactLiu Bin
The Second Hospital of Jilin University
Outcome results
None listed