ShenFu Injection for Myocardial Protection in Patients With Acute ST Segment Elevation Myocardial Infarction (SF-STEMI)

Capital Medical University

Status and phase: Completed; Phase 4

Conditions: Myocardial Infarction

Treatments: Drug: Shenfu Injection; Drug: 5% Glucose Injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02709798

D99-2015(043)-TCM-4

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Shenfu Injection

Experimental group

Description:

80ml Shenfu Injection + 70ml 5% glucose injection), ivdrip, 30 minutes before PCI and 1-5 days (once a day) after PCI (6 times in total). Drug titration time should be no less than 30 minutes.

Treatment:

Drug: Shenfu Injection

5% Glucose Injection

Placebo Comparator group

Description:

150 ml 5% glucose injection, ivdrip, 30 minutes before PCI and 1-5 days (once a day) after PCI (6 times in total). Drug titration time should be no less than 30 minutes.

Treatment:

Drug: 5% Glucose Injection