Clinical trial NCT02709798: ShenFu Injection for Myocardial Protection in Patients With Acute ST Segment Elevation Myocardial Infarction
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Keywords: Shenfu Injection
Reperfusion Injury
Myocardial Protection
Percutaneous Coronary Intervention
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
Collaborators: name: China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.
First posted: 2016-03-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Infarct size
timeFrame: 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:
measure: AUC of cardiac troponin I (cTnI)
timeFrame: immediately after admission (0 hour), and 6, 12, 18, 24, 48, and 72 hours after PCI
measure: Peak value of CK-MB and cTnI
timeFrame: 72 hours after PCI
measure: ST segment resolution (%) according to ECG
timeFrame: up to 24 hours after PCI
measure: Left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD), and Left ventricular ejection fraction (LVEF)
timeFrame: up to 28 days after PCI
measure: 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)
timeFrame: up to 28 days after PCI
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
Study officials:
References:
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.