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

NCT ID: NCT02709798

Last Updated: 2018-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-02-28

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

Conditions

Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Shenfu Injection

Intervention Type: DRUG

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.

Group Type: PLACEBO_COMPARATOR

5% Glucose Injection

Intervention Type: DRUG

Interventions

Shenfu Injection

Intervention Type: DRUG

5% Glucose Injection

Intervention Type: DRUG

Other Intervention Names

Shenfu Zhusheye

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shao-Ping Nie

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Anzhen Hospital, Capital Medical University

Beijing, , China

Countries

China

References

Wang X, Miao H, Yan Y, Guo R, Gong W, He Y, Wang H, Ma X, Nie S. Effect of Shenfu Injection on Reperfusion Injury in Patients Undergoing Primary Percutaneous Coronary Intervention for ST Segment Elevation Myocardial Infarction: A Pilot Randomized Clinical Trial. Front Cardiovasc Med. 2021 Dec 3;8:736526. doi: 10.3389/fcvm.2021.736526. eCollection 2021.

Reference Type: DERIVED

PMID: 34926601 (View on PubMed)

Other Identifiers

D99-2015(043)-TCM-4

Identifier Type: -

Identifier Source: org_study_id