Ischemia and Non-Obstructive Coronary Artery Disease
Conditions
Interventions
Control group:Placebo
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participates, understands, and signs the informed consent form. 2. Age >=18 years and 25 frames). Positive results from an exercise stress test on electrocardiogram (ECG). ECG during chest pain episodes showing typical signs of myocardial ischemia. Evidence of reversible myocardial ischemia on stress nuclear myocardial perfusion imaging or stress echocardiography within the past three months. c. Experiences recurrent chest pain despite current treatment (symptoms have not improved or have only slightly improved, significantly affecting daily life).
Exclusion criteria
Exclusion criteria: 1. History of Myocardial Infarction: Patients with a prior history of myocardial infarction. 2. Poorly Controlled Hypertension: Defined as resting systolic blood pressure >=180 mmHg and/or diastolic blood pressure >=110 mmHg on two separate measurements prior to randomization. 3. Severe Liver or Kidney Dysfunction: Liver transaminases (ALT or AST) or bilirubin exceeding three times the upper limit of normal for any reason, or glomerular filtration rate less than 15 mL/min/1.73 m². 4. Hematologic Disorders: Hemoglobin concentration <=9 g/dL and/or any hematologic diseases. 5. Untreated Valvular or Congenital Heart Disease: Patients with valvular heart disease or congenital heart disease who have not undergone surgery. 6. Epicardial Variant Angina: Presence of large-vessel variant angina. 7. Cardiomyopathies: Hypertrophic, dilated, restrictive cardiomyopathy, or other secondary or infiltrative cardiomyopathies. 8. Active Myocarditis: Presence of active myocarditis. 9. Pericardial Diseases: Constrictive pericarditis or other pericardial diseases. 10. Syncope: History of syncope within the past three months. 11. Symptomatic Bradycardia or Conduction Disorders: Symptomatic bradycardia or second- or third-degree heart block without a pacemaker. 12. Malignant Ventricular Arrhythmias: Malignant ventricular arrhythmias affecting hemodynamics. 13. Recent Cardiac Device Implantation: Implantation of a cardiac resynchronization therapy pacemaker (CRT-P) or defibrillator (CRT-D), upgrading from a conventional pacemaker or implantable cardioverter defibrillator (ICD) to a CRT device within the past six months, or plans for similar device implantation within the next six months. 14. Recent Cardiac Events or Procedures: Events within the past three months including worsening heart failure (NYHA class III–IV), acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid, or other major vascular surgery, percutaneous coronary intervention (PCI), carotid angioplasty, coronary artery bypass grafting, or other cardiac surgeries. 15. Major Surgery: Major surgery within the past six months prior to randomization. 16. Exercise Intolerance: Inability to tolerate treadmill or bicycle exercise stress tests due to musculoskeletal disorders. 17. Severe Pulmonary Disorders: Severe chronic obstructive pulmonary disease (COPD), cor pulmonale, severe pulmonary vascular disease, pulmonary hypertension due to autoimmune disease, or any type of severe pulmonary arterial hypertension. 18. Organ Transplant: History of major organ transplantation (e.g., lung, liver, heart, bone marrow, kidney). 19. Severe Systemic Diseases: Severe primary diseases of the liver, kidneys, hematopoietic system, nervous system, or endocrine system; malignancies; or psychiatric disorders. 20. Limited Life Expectancy: Expected life expectancy of less than one year for any reason. 21. Known Drug Allergy: Known allergy to any investigational drugs. 22. Participation in Other Trials: Participation in another drug clinical trial within the past month. 23. Use of Similar Medications: Use of traditional Chinese medicines or herbal preparations with similar ingredients to Qishen Yiqi Dripping Pills within the past month. 24. Pregnancy or Lactation: Positive pregnancy test, current breastfeeding, or women of childbearing potential not using adequate contraception. 25. Inability to Comply: Judged by the investigator as unable to complete the study or comply with study requirements due to lo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| myocardial?flow?reserve,?MFR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Myocardial Blood Flow;High-frequency QRS Electrocardiographic Monitoring for Myocardial Ischemia;Angina Classification;All-cause mortality, cardiovascular death, myocardial infarction or coronary revascularization, rehospitalization due to angina, composite endpoint events.; | — |
Countries
China
Contacts
Public ContactDianfu Li
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed