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| Name | Class |
|---|---|
| China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. | INDUSTRY |
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shenfu Injection | Drug |
|
| |
| 5% Glucose Injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Beijing | 100029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34926601 | Derived | 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. |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D015427 | Reperfusion Injury |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C492793 | Shen-Fu |
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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| Drug |
|
| 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 |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D011183 | Postoperative Complications |