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

Myocardial Infarction Clinical Trial

— SF-STEMI  

Official title:

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Effect of Shenfu Injection on Reperfusion Injury in Patients With Acute ST Segment Elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention: A Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02709798
• Other study ID #: D99-2015(043)-TCM-4
• Status: Completed
• Phase: Phase 4
• Start date: April 2016
• Est. completion date: February 2018

Study information

• Verified date: August 2018
• Source: Beijing Anzhen Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Reperfusion Injury
• ST Elevation Myocardial Infarction

Intervention

Drug:
• Shenfu Injection

• 5% Glucose Injection

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital	China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infarct size	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.	immediately after admission (0 hour), and 6, 12, 18, 24, 48, and 72 hours after PCI, as well as 4±1days after PCI
Secondary	AUC of cardiac troponin I (cTnI)		immediately after admission (0 hour), and 6, 12, 18, 24, 48, and 72 hours after PCI
Secondary	Peak value of CK-MB and cTnI		72 hours after PCI
Secondary	ST segment resolution (%) according to ECG		up to 24 hours after PCI
Secondary	Left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD), and Left ventricular ejection fraction (LVEF)		up to 28 days after PCI
Secondary	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