Coronary heart disease
Conditions
Interventions
Reganosen Group:Reganosen was given 0.4mg intravenous infusion, and 10 minutes later, Reganosen was given 15ug/min maintenance treatment for 1 hour.
Control Group:0.4mg of normal saline was injected intravenously, and 15ug/min of normal saline was given for 1 hour after 10 minutes.
Phase I Trial Group:Reganosen was given 0.4mg intravenous infusion, and 10 minutes later, Reganosen was given 15ug/min maintenance treatment for 1 hour.
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients aged 18-80 years; Chest pain onset time is =30 minutes and =24 hours ST-segment elevation of =0.1 mV in two or more adjacent leads on electrocardiogram (ECG); Agree to receive emergency PCI treatment and have no contraindications for such treatment; Immediate assessment of coronary flow reserve (caIMR) after PCI, with caIMR > 40; Agree to participate in this study and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: Hemodynamic instability (such as cardiogenic shock, heart failure, respiratory failure, requiring vasoactive drugs to maintain or tracheal intubation, etc.) before, during, or after emergency PCI surgery. High-risk patients with target lesions involving the left main stem. Stenosis of more than 70% in other coronary arteries, excluding the target vessel. Bradycardia, frequent ventricular premature beats, second-degree or higher atrioventricular block, sinus arrest, or escape rhythm, etc., occurring immediately during or after PCI surgery. Concurrent pre-excitation syndrome. History of coronary artery bypass grafting (CABG). History of asthma. Acute and chronic infectious diseases (such as severe pneumonia). History of hemorrhagic stroke within the past six months. Severe liver dysfunction (total bilirubin > 3 times the upper limit of normal, ULN) and renal insufficiency (estimated glomerular filtration rate, EGFR < 30 ml/min/1.73m2) due to various causes. History of various types of cardiomyopathy. Severe anemia, thrombocytopenia, and other hematologic diseases. Malignant tumors, autoimmune diseases, and patients using glucocorticoids and immunosuppressants for various reasons. Pregnant women, nursing women, and patients who plan to become pregnant during the study period. Patients participating in other interventional clinical studies or those whom the researcher considers unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ST segment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Index of Microcirculatory Resistance;MACE;cardiac function;grading of angina; | — |
Countries
China
Contacts
Public ContactChen Zhangwei
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed