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

NCT02709798 | Completed Phase 4

• 1 other identifier: D99-2015(043)-TCM-4
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Shenfu Injection; Reperfusion Injury; Myocardial Protection; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• AUC of cardiac troponin I (cTnI)

  immediately after admission (0 hour), and 6, 12, 18, 24, 48, and 72 hours after PCI

• Peak value of CK-MB and cTnI

  72 hours after PCI

• ST segment resolution (%) according to ECG

  up to 24 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

Study Arms (2)

Shenfu Injection

EXPERIMENTAL

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.

Drug: Shenfu Injection

5% Glucose Injection

PLACEBO COMPARATOR

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.

Drug: 5% Glucose Injection

Interventions

Shenfu Injection DRUG

Also known as: Shenfu Zhusheye

Shenfu Injection

5% Glucose Injection DRUG

5% Glucose Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 and \<75 years;
• First-time acute anterior STEMI;
• The time from onset of ischemic symptom to the time of initial PCI balloon inflation ≤6 hours;
• \>0.1 mV ST segment elevation in at least two contiguous precordial leads according to electrocardiogram;
• Scheduled for primary PCI;
• 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;
• Written informed consent.

You may not qualify if:

• Hypertrophic cardiomyopathy, aortic valve stenosis and/or regurgitation, pericarditis, or myocarditis;
• Cardiogenic shock, severe ventricular arrhythmia, serious heart failure (Killip class III and above) or mechanical complications;
• Patients after cardiopulmonary resuscitation (CPR) (including cardioversion);
• Patients who have already received thrombolytic therapy;
• Prior myocardial infarction or coronary artery bypass surgery;
• Known serious hepatic, renal, blood, respiratory, or neuropsychiatric diseases;
• Malignant tumor, lymphoma, HIV-positive, or hepatitis;
• Uncontrolled hypertension (systolic BP \>160 mm Hg or a diastolic BP \>100 mmHg on at least two consecutive readings);
• Patients with active bleeding, major surgery or trauma within 3 months and cerebrovascular accident within 6 months;
• History of anemia (hemoglobin\<90g/L) or thrombocytopenia (thrombocyte\<90×109/L);
• Multi-vessel disease with non-culprit vessel intervention;
• Breastfeeding, pregnant, or potentially fertile women;
• Patients who have known to be allergic to Shenfu Injection or its components or patients with serious adverse effect;
• Patients with potential contraindication to CMR;
• Participation in other clinical trial in recent 3 months;

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead
• China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, 100029, China

Location

Related Publications (1)

• 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.

  PMID: 34926601 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Reperfusion Injury

Interventions

Shen-Fu; Glucose

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Postoperative Complications

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: March 16, 2016
• Study Start: April 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: August 7, 2018

Record last verified: 2018-08

Locations

CN (1)