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

Primary Purpose

Myocardial Infarction

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Shenfu Injection

5% Glucose Injection

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Shenfu Injection, Reperfusion Injury, Myocardial Protection, Percutaneous Coronary Intervention

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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;
Patients who cannot complete this trial or comply with the protocol.

Sites / Locations

Beijing Anzhen Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Shenfu Injection

5% Glucose Injection

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

AUC of cardiac troponin I (cTnI)

Peak value of CK-MB and cTnI

ST segment resolution (%) according to ECG

Left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD), and Left ventricular ejection fraction (LVEF)

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)

Full Information

NCT ID

NCT02709798

First Posted

March 11, 2016

Last Updated

August 6, 2018

Sponsor

Beijing Anzhen Hospital

Collaborators

China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02709798

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

April 2016 (Actual)

Primary Completion Date

February 2018 (Actual)

Study Completion Date

February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Anzhen Hospital

Collaborators

China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Shenfu Injection

Arm Type

Experimental

Arm 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.

Arm Title

5% Glucose Injection

Arm Type

Placebo Comparator

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Shenfu Injection

Other Intervention Name(s)

Shenfu Zhusheye

Intervention Type

Drug

Intervention Name(s)

5% Glucose Injection

Primary Outcome Measure Information:

Title

Infarct size

Description

Time Frame

immediately after admission (0 hour), and 6, 12, 18, 24, 48, and 72 hours after PCI, as well as 4±1days after PCI

Secondary Outcome Measure Information:

Title

AUC of cardiac troponin I (cTnI)

Time Frame

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

Title

Peak value of CK-MB and cTnI

Time Frame

72 hours after PCI

Title

ST segment resolution (%) according to ECG

Time Frame

up to 24 hours after PCI

Title

Left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD), and Left ventricular ejection fraction (LVEF)

Time Frame

up to 28 days after PCI

Title

Time Frame

up to 28 days after PCI

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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; Patients who cannot complete this trial or comply with the protocol.

Facility Information:

Facility Name

Beijing Anzhen Hospital, Capital Medical University

City

Beijing

ZIP/Postal Code

100029

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

34926601

Citation

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.

Results Reference

derived

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

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