coronary heart disease
Conditions
Interventions
Gold Standard:Coronary angiography combined with stress radionuclide myocardial perfusion imaging.
Index test:(1)Myocardial 
ischemia: 
combined 
with 
caIMR 
from 
FAS(FlashAngio 
System).
(2)Atherosclerotic 
System).
(3)Myocardial 
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Between 18-80 years old; (2) Subjects with stable and unstable angina pectoris; (3) Subjects (or legal guardians) understand the study requirements and treatment procedures and are able to provide written informed consents before conducting specific tests or procedures; (4) Subjects are willing to comply with the clinical assessments required by the study protocol, including tests that agreed and are able to tolerate stress myocardial perfusion imaging (exercise or adenosine triphosphate as the stress), coronary angiography, coronary fractional flow reserve, and index of microcirculatory resistance etc..
Exclusion criteria
Exclusion criteria: (1) Subjects with acute phase of myocardial infarction; (2) Subjects have received an organ transplant or are waiting to receive an organ transplant; (3) Subjects are receiving or planning to receive chemotherapy within 30 days before and after coronary angiography; (4) Subjects are allergic to iodine contrast agent and adenosine; (5) Subjects are known to have the following conditions (based on the evaluation at the time of screening): 1) Other serious diseases that may reduce life expectancy to less than 24 months (such as cancer, congestive heart failure); 2) Currently having drug abuse issues (such as alcohol, cocaine, heroin, etc.); 3) plan to receive surgery that may cause non-compliance or confusing data; (6) Subjects whose blood cell count (CBC) is out of range, and the research doctor confirms that it has clinical significance; (7) Subjects have clear or suspected liver disease, including laboratory evidence of hepatitis; (8) Subjects are undergoing dialysis or the baseline serum creatinine level is >2.0 mg/dL (177µmol/L); (9) Subjects have a tendency to hemorrhage or a history of coagulopathy or refuse blood transfusion; (10) Subjects have active gastric ulcer or active gastrointestinal bleeding; (11) Subjects are participating in other clinical trials and have not reached its primary endpoint; (12) Subjects are pregnants or lactating women (women of childbearing age must undergo a pregnancy test within 7 days before the coronary angiography). (13) Angiographic exclusion criteria: 1) The interrogated stenosis is caused by myocardial bridge; 2) Ostial lesions; 3) Pool contrast agent filling, vascular overlap or severe distortion of the interrogated vessel, and poor angiographic image quality precluding contour detection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of caFFR combined with caIMR and radionuclide myocardial perfusion imaging in the diagnosis of myocardial ischemia;The ROC curve and the area under the curve of FlashAngio FFR System in assessment of myocardial ischemia with radionuclide myocardial perfusion imaging as the contrast; | — |
Secondary
| Measure | Time frame |
|---|---|
| Accuracy of caFFR in diagnose myocardial ischemia due to atherosclerosis;Accuracy of caIMR in diagnose myocardial ischemia due to microcirculatory disturbance;The calculation success rate of caFFR and caIMR; | — |
Countries
China
Contacts
Public ContactHu Ai
Department of Cardiology, Beijing Hospital
Outcome results
None listed