ShenFu Injection for Myocardial Protection in Patients With Acute ST Segment Elevation Myocardial Infarction

Phase 4

Completed

• Conditions: Myocardial Infarction
• Interventions: Drug: Shenfu Injection; Drug: 5% Glucose Injection

• Registration Number: NCT02709798
• Lead Sponsor: Beijing Anzhen Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-11
• Study First Submitted QC: 2016-03-15
• Study First Posted: 2016-03-16
• Study Start: 2016-04
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-06
• Last Update Posted: 2018-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shenfu Injection	Shenfu Injection	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.
5% Glucose Injection	5% Glucose Injection	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Peak value of CK-MB and cTnI	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
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
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

Trial Locations

Locations (1)

Beijing Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, China