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Randomized Evaluation of Shenfu Injection to Reduce Myocardial Injury (RESTORE)

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ClinicalTrials.gov Identifier: NCT04493840
Recruitment Status : Recruiting
First Posted : July 30, 2020
Last Update Posted : September 10, 2021
Sponsor:
Information provided by (Responsible Party):
Shao-Ping Nie, Beijing Anzhen Hospital

Brief Summary:
This study aims to evaluate whether perioperative use of Shenfu Injection, as compared to placebo, could reduce infarct size assessed by cardiac magnetic resonance (CMR) in patients with acute anterior ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI).

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Shenfu Injection Drug: 5% Glucose Injection Phase 4

Detailed Description:
Shenfu injection is a traditional Chinese medicine formulation containing ginseng (Panax; family: Araliaceae) and aconite (Radix aconiti lateralis preparata, Aconitum carmichaeli Debx; family: Ranunculaceae) with Ginsenosides and aconite alkaloids as the main active ingredients. Its quality is strictly controlled in compliance with the standard of the China Ministry of Public Health (official approval code: certification number Z20043117; No. 110804, Ya'an, China). Animal studies have shown that Shenfu injection has protective effects against reperfusion injury through multiple pharmacologic effects, including scavenging free radicals, inhibiting inflammatory mediators, suppressing cell apoptosis, and inhibiting calcium overload. However, few data are available regarding its efficacy in humans. We aimed to determine whether perioperative use of Shenfu injection, as compared to placebo, might reduce infarct size in patients with STEMI undergoing primary PCI.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 326 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Shenfu Injection on Myocardial Injury in Patients With Acute ST Segment Elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention: A Multicenter, Randomized, Double-Blinded, Parallel-Group, Placebo-Controlled Clinical Trial
Actual Study Start Date : July 30, 2020
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Shenfu Injection Drug: Shenfu Injection
80ml Shenfu Injection + 70ml 5% glucose injection, ivdrip, within 30 minutes before PCI and 1 to 5 days (once a day) after PCI (6 times in total). Drug titration time should be no less than 30 minutes.

Placebo Comparator: 5% Glucose Injection Drug: 5% Glucose Injection
150 ml 5% glucose injection, ivdrip, within 30 minutes before PCI and 1 to 5 days (once a day) after PCI (6 times in total). Drug titration time should be no less than 30 minutes.




Primary Outcome Measures :
  1. Infarct size (% of left ventricular mass) [ Time Frame: 5±2 days after PCI ]
    Infarct size was assessed by performing CMR imaging at 5±2 days after PCI


Secondary Outcome Measures :
  1. Microvascular obstruction (% of left ventricular mass) [ Time Frame: 5±2 days after PCI ]
  2. Intramyocardial hemorrhage (% of left ventricular mass) [ Time Frame: 5±2 days after PCI ]
  3. Area under the curve (AUC) of creatine kinase isoenzyme (CK-MB) [ Time Frame: Immediately after admission (0 hour), and 6, 12, 18, 24, 48, and 72 hours after PCI ]
  4. AUC of cardiac troponin I [ Time Frame: Immediately after admission (0 hour), and 6, 12, 18, 24, 48, and 72 hours after PCI ]
  5. Peak value of CK-MB and cTnI [ Time Frame: 72 hours after PCI ]
  6. ST segment resolution (%) according to ECG [ Time Frame: 24 hours after PCI ]
  7. TIMI flow grade [ Time Frame: Immediately after PCI ]
  8. Corrected TIMI frame count (CTFC) [ Time Frame: Immediately after PCI ]
  9. TIMI myocardial perfusion grade (TMPG) [ Time Frame: Immediately after PCI ]
  10. Myocardial salvage index [ Time Frame: 5±2 days after PCI ]
  11. Area at risk (myocardial edema, % of left ventricular mass) [ Time Frame: 5±2 days after PCI ]
  12. Left ventricular end-diastolic volume (LVEDV) [ Time Frame: 5±2 days after PCI ]
  13. Left ventricular end-systolic volume (LVESV) [ Time Frame: 5±2 days after PCI ]
  14. Left ventricular ejection fraction (LVEF) [ Time Frame: 5±2 days after PCI ]
  15. Major adverse cardiovascular and cerebrovascular events (MACCE, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, emergency revascularization) [ Time Frame: 30 days after PCI ]
  16. Individual events (including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, emergency revascularization, re-hospitalization for heart failure) [ Time Frame: 30 days after PCI ]

Other Outcome Measures:
  1. Slow flow and no flow [ Time Frame: Index procedure ]
  2. Malignant arrhythmia (ventricular fibrillation, ventricular tachycardia, etc.) [ Time Frame: Index procedure ]
  3. Value of high-sensitivity C-reactive protein (Hs-CRP) [ Time Frame: Immediately after admission (0 hour), and 24, 72 hours and 5 days after PCI ]
  4. Value of brain natriuretic peptide (BNP) [ Time Frame: Immediately after admission (0 hour), and 24, 72 hours and 5 days after PCI ]
  5. The Myocardial Infarction Dimensional Assessment Scale (MIDAS) [ Time Frame: 6 hours and 30 days after PCI ]
    0 to 140 scores, higher scores mean worse outcome



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 and <75 years.
  2. First-time acute anterior STEMI scheduled for primary PCI.
  3. ST segment elevation in at least two contiguous precordial leads according to electrocardiogram (>30 min).
  4. Symptoms onset ≤12 hours.
  5. The presence of proximal or middle left anterior descending branch (LAD) occlusion with pre-PCI TIMI flow 0 or 1 according to baseline coronary angiogram.
  6. Written informed consent.

Exclusion Criteria:

  1. Cardiogenic shock, serious heart failure (Killip class III or above), malignant ventricular arrhythmia, or mechanical complications.
  2. Post cardiopulmonary resuscitation (CPR) (including cardioversion).
  3. Patients who have received thrombolytic therapy or upstream GPIIb/IIIa inhibitors (GPI).
  4. Uncontrolled hypertension (systolic BP ≥180 mm Hg or a diastolic BP ≥110 mmHg).
  5. Prior myocardial infarction, PCI or coronary artery bypass graft.
  6. Known severe hepatic insufficiency (AST/ALT >3-fold the upper limit of normal value) or known renal insufficiency.
  7. Malignant tumor, lymphoma, HIV-positive, or cirrhosis with life expectancy <1 year.
  8. Patients with active bleeding, intracranial hemorrhage, major surgery or trauma within 1 months, or ischemic stroke or transient ischemic attack (TIA) within 6 months.
  9. History of anemia (hemoglobin<90g/L) or thrombocytopenia (thrombocyte<100×109/L).
  10. Patients who require simultaneous intervention of left main disease during primary PCI or those with multi-vessel disease who plan to intervene in non-culprit vessels within 7 days (simultaneous or staged).
  11. Scheduled for CABG within one month after randomization.
  12. Pregnancy, lactation, 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 contraindication to CMR (metal foreign body in the body, claustrophobia, etc.).
  15. Participation in other clinical trial in recent 3 months.
  16. Patients who cannot complete this trial or comply with the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04493840


Contacts
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Contact: Shao-Ping Nie, MD, PhD 86-10-84005256 spnie@ccmu.edu.cn
Contact: Xiao Wang, MD 86-10-84005255 spaceeye123@126.com

Locations
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China
Beijing Anzhen Hospital, Capital Medical University Recruiting
Beijing, China
Contact: Shao-Ping Nie, MD, PhD    86-10-84005256    spnie@ccmu.edu.cn   
Contact: Xiao Wang, MD    86-10-84005255    spaceeye123@126.com   
Principal Investigator: Shao-Ping Nie, MD, PhD         
Sponsors and Collaborators
Beijing Anzhen Hospital
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Responsible Party: Shao-Ping Nie, Professor of Medicine, Director, Emergency & Critical Care Center, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT04493840    
Other Study ID Numbers: 2019013
First Posted: July 30, 2020    Key Record Dates
Last Update Posted: September 10, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases