Periprocedural Myocardial Injury Associated with PCI
Conditions
Interventions
Treatment group:In addition to the standard of care (SOC), patients will receive Qixuekang Oral Liquid (30 ml, orally, twice daily).
Control Group:In addition to the standard of care (SOC), patients will receive Qixuekang Oral Liquid placebo (30 ml, orally, twice daily).
Sponsors
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 79 Years
Inclusion criteria
Inclusion criteria: (1)Age between 40 and 79 years (inclusive); (2)Patients diagnosed with coronary heart disease, presenting with angina symptoms, and scheduled for elective PCI; (3)Normal hs-cTnI level prior to the procedure; (4)Fulfilling the Traditional Chinese Medicine diagnostic criteria for Qi deficiency and blood stasis syndrome; (5)Voluntarily sign the written informed consent form.
Exclusion criteria
Exclusion criteria: (1)History of myocardial infarction within the past 28 days; (2)Hemodynamic instability, cardiogenic shock, recurrent or persistent chest pain refractory to medical therapy, acute heart failure presumed secondary to ongoing myocardial ischemia, life-threatening arrhythmias, cardiac arrest, mechanical complications, or recurrent dynamic electrocardiogram (ECG) changes indicative of ischemia (especially intermittent ST-segment elevation); (3)Presence of severe cardiovascular diseases (e.g., refractory heart failure, severe valvular heart disease); poorly controlled hypertension (systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100 mmHg despite treatment); poorly controlled diabetes mellitus (random blood glucose = 10.0 mmol/L or glycated hemoglobin [HbA1c] = 7.0%); severe respiratory diseases (e.g., severe pulmonary insufficiency); severe hepatic or renal impairment, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 2 times the upper limit of normal (ULN), or serum creatinine > 2 times the ULN; or other severe conditions including malignancies, moderate-to-severe anemia (hemoglobin < 90 g/L), and severe renal artery stenosis; (4)Presence of other diseases or factors known to elevate hs-cTnI levels, such as myocarditis or the concurrent use of cardiotoxic agents (e.g., anthracyclines); (5)Pregnant or lactating women, or those planning to conceive; (6)Participation in another interventional clinical trial within 1 month prior to screening; (7)Known hypersensitivity or allergy to any components of the study drug; (8)Patients deemed unable to complete the study or comply with study requirements, as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| High-Sensitivity Troponin I(hs-cTnI)levels;Seattle Angina Questionnaire (SAQ) summary score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Periprocedural Myocardial Injury Associated with PCI;Creatine kinase-MB (CK-MB) levels;High-sensitivity C-reactive protein (hs-CRP) levels;Seattle Angina Questionnaire (SAQ) subscale scores;Chest pain Visual Analogue Scale (VAS) score;Canadian Cardiovascular Society (CCS) angina class;Nitroglycerin Withdrawal and Reduction Rate;Traditional Chinese Medicine (TCM) syndrome score;Incidence of major adverse cardiovascular events (MACE); | — |
Countries
China
Contacts
Public ContactWang Xianliang
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed