Coronary atherosclerotic heart disease
Conditions
Interventions
Gold Standard:Transcatheter coronary angiography showing coronary stenosis >= 50% and stress radionuclide myocardial perfusion imaging positive
Index test:Fractional Flow Reserve derived from Coronary Angiography, caFFR
Sponsors
beijing hospital
Eligibility
Sex/Gender
All
Age
65 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age is over 65 and under 85 2. The subjects are patients suspected of coronary heart disease 3. The subjects (or legal guardian) understand the research requirements and treatment procedures and can provide written informed consent before conducting specific examinations or procedures 4. The subjects are willing to comply with the clinical evaluation required by the study protocol, including consent and tolerance to stress radionuclide myocardial perfusion imaging (exercise or adenosine triphosphate load), coronary angiography, coronary flow reserve fraction measurement, and other examinations.
Exclusion criteria
Exclusion criteria: 1. The subjects are patients with acute myocardial infarction; 2. Subjects have received or are waiting for organ transplantation; 3. Subjects are receiving or planning to receive chemotherapy within 30 days before and after surgery; 4. Subjects are allergic to iodine contrast agents and adenosine; 5. Subjects are known to have the following conditions (based on the evaluation at screening): Other serious diseases that may reduce life expectancy to less than 24 months (such as cancer, congestive heart failure); 6. There are drug abuse problems (such as alcohol, cocaine, heroin, etc.); 7. Plan to accept surgery that may cause protocol non-compliance or data understanding confusion; 8. Subjects are receiving long-term (>= 72 hours) anticoagulant therapy (such as heparin and warfarin) to treat diseases other than acute coronary syndrome (ACS); 9. The whole blood cell count (CBC) of the subjects is out of the range, which is confirmed by the study doctor to be of clinical significance; 10. Subjects with definite or suspected liver disease, including laboratory evidence of hepatitis; 11. Subjects are undergoing dialysis or baseline serum creatinine level>2.0 mg/dL (177 µ mol/L); 12. Subjects with a bleeding tendency or a history of coagulation disease or refused a blood transfusion; 13. Subjects with active gastric ulcer or active gastrointestinal bleeding; 14. The subjects are participating in the clinical study of other research drugs or devices and has not reached its primary endpoint; 15. The subjects are pregnant or lactating women (women of childbearing age must have a pregnancy test within 7 days before surgery); 16. Exclusion criteria of coronary angiography: (1) The target coronary artery stenosis involves the myocardial bridge; (2) Coronary artery ostium lesion; (3) The contrast agent is not filled, the vessels overlap or the target vessels are severely distorted, the lesion position cannot be fully exposed, the image quality is poor, and the image cannot be clearly identified.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fractional Flow Reserve derived from Coronary Angiography, caFFR; | — |
Countries
China
Contacts
Public ContactGuojian Yang
Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine
Outcome results
None listed