incomplete revascularization of coronary heart disease
Conditions
Interventions
Control group:placebo of Guanxinning tablet
Sponsors
Fuwai Huazhong Cardiovascular Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Age>= 18 years old; (2) Consistent with a diagnosis of coronary artery disease, without complete revascularization (coronary angiography or coronary CTA angiography with a diameter stenosis of >= 50% and a QFR 2.75 mm), and a QFR of at least one main branch > 0.90; (3) CT myocardial perfusion showed myocardial ischemia; (4) Symptoms of myocardial ischemia (angina pectoris at rest or exertion; angina allele: shortness of breath, etc.), consistent with blood stasis;
Exclusion criteria
Exclusion criteria: (1) Patients with heart failure with NYHA cardiac function grade IV, or ejection fraction 180 mm Hg or DBP>110 mm Hg); (6) Active liver disease or persistent ALT or AST elevation = 3 times; (7) 5-fold unexplained CK > or elevated CK due to known muscle disease; (8) Planned or expected cardiac surgery or revascularization prior to randomization; (9) The patient has taken other traditional Chinese medicines or medicines containing proprietary Chinese medicine ingredients half a month before enrollment; (10) History of active malignancy (surgery, radiation therapy, and/or systemic therapy within the past three years); (11) Currently participating in another drug or device study, or less than 30 days after just ending another drug or device study or receiving other study drugs; (12) Any life-threatening comorbidity (other than CVD) that is expected to result in death within the next 1 year; (13) History of alcoholism and drug abuse; and the canteen/unwillingness to abstain from alcohol and discontinue substance abuse for the duration of the study; (14) Have received transplantation from major organs (e.g., lung, liver, heart, bone marrow, kidney); (15) Significant active and uncontrolled disease judged by the investigator to be significant, or any medical, physical, or surgical condition (such as infection or significant hematological, renal, metabolic, gastrointestinal, or endocrine dysfunction, etc.) that may interfere with participation in this clinical study; (16) To the best of the investigator's knowledge, the subject has a low likelihood of follow-up follow-up or is not expected to complete more than 1 year of follow-up (the subject may not be able to complete the follow-up or procedures required by the study protocol); (17) Psychiatric/psychological/neurocognitive impairment or any other reason that anticipates the subject's difficulty in complying with the requirements of the study or understanding the objectives and potential risks of participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in myocardial perfusion on CT after 6 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in MBF at 6 months of CT perfusion resting/loading;Seattle Angia Rating Scale;TCM Syndrome Integral Scale;6-minute walk test;Short-acting nitrate depletion rate;Endpoint events; | — |
Countries
China
Contacts
Public ContactLi Muwei
Fuwai Huazhong Cardiovascular Hospital
Outcome results
None listed