Myocardial Infarction
Conditions
Keywords
Shenfu Injection, Reperfusion Injury, Myocardial Protection, Percutaneous Coronary Intervention
Brief summary
The purpose of this study is to evaluate whether perioperative use of Shenfu Injection could reduce myocardial injury (enzymatic infarct size and infarct volume according to cardiac magnetic resonance imaging) in patients with STEMI after primary PCI
Interventions
Sponsors
China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.
Beijing Anzhen Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 and \<75 years; 2. First-time acute anterior STEMI; 3. The time from onset of ischemic symptom to the time of initial PCI balloon inflation ≤6 hours; 4. \>0.1 mV ST segment elevation in at least two contiguous precordial leads according to electrocardiogram; 5. Scheduled for primary PCI; 6. The presence of left anterior descending branch (LAD) occlusion in proximal or middle segment with pre-PCI TIMI flow 0 or 1 according to baseline coronary angiogram; 7. Written informed consent.
Exclusion criteria
1. Hypertrophic cardiomyopathy, aortic valve stenosis and/or regurgitation, pericarditis, or myocarditis; 2. Cardiogenic shock, severe ventricular arrhythmia, serious heart failure (Killip class III and above) or mechanical complications; 3. Patients after cardiopulmonary resuscitation (CPR) (including cardioversion); 4. Patients who have already received thrombolytic therapy; 5. Prior myocardial infarction or coronary artery bypass surgery; 6. Known serious hepatic, renal, blood, respiratory, or neuropsychiatric diseases; 7. Malignant tumor, lymphoma, HIV-positive, or hepatitis; 8. Uncontrolled hypertension (systolic BP \>160 mm Hg or a diastolic BP \>100 mmHg on at least two consecutive readings); 9. Patients with active bleeding, major surgery or trauma within 3 months and cerebrovascular accident within 6 months; 10. History of anemia (hemoglobin\<90g/L) or thrombocytopenia (thrombocyte\<90×109/L); 11. Multi-vessel disease with non-culprit vessel intervention; 12. Breastfeeding, pregnant, or potentially fertile women; 13. Patients who have known to be allergic to Shenfu Injection or its components or patients with serious adverse effect; 14. Patients with potential contraindication to CMR; 15. Participation in other clinical trial in recent 3 months; 16. Patients who cannot complete this trial or comply with the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infarct size | immediately after admission (0 hour), and 6, 12, 18, 24, 48, and 72 hours after PCI, as well as 4±1days after PCI | Infarct size was assessed by measuring the area under the curve (AUC) of creatine kinase isoenzyme (CK-MB) within 72 hours after PCI and by performing cardiac magnetic resonance (CMR) imaging at 4±1days after PCI. |
Secondary
| Measure | Time frame |
|---|---|
| Peak value of CK-MB and cTnI | 72 hours after PCI |
| ST segment resolution (%) according to ECG | up to 24 hours after PCI |
| AUC of cardiac troponin I (cTnI) | immediately after admission (0 hour), and 6, 12, 18, 24, 48, and 72 hours after PCI |
| Left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD), and Left ventricular ejection fraction (LVEF) | up to 28 days after PCI |
| Main adverse cardiovascular and cerebrovascular events (MACCE, including death, non-fatal myocardial infarction, target vessel revascularization, stroke, new-onset severe heart failure, re-hospitalization for heart failure) | up to 28 days after PCI |
Countries
China
Outcome results
None listed