Randomized Evaluation of Shenfu Injection to Reduce Myocardial Injury

NCT04493840 | Unknown Phase 4

• 1 other identifier: 2019013
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 1

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).

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Infarct size (% of left ventricular mass)

  Infarct size was assessed by performing CMR imaging at 5±2 days after PCI

  5±2 days after PCI

Secondary Outcomes (16)

• Microvascular obstruction (% of left ventricular mass)

  5±2 days after PCI

• Intramyocardial hemorrhage (% of left ventricular mass)

  5±2 days after PCI

• Area under the curve (AUC) of creatine kinase isoenzyme (CK-MB)

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

• AUC of cardiac troponin I

  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

Other Outcomes (5)

• Slow flow and no flow

  Index procedure

• Malignant arrhythmia (ventricular fibrillation, ventricular tachycardia, etc.)

  Index procedure

• Value of high-sensitivity C-reactive protein (Hs-CRP)

  Immediately after admission (0 hour), and 24, 72 hours and 5 days after PCI

Study Arms (2)

Shenfu Injection

EXPERIMENTAL

Drug: Shenfu Injection

5% Glucose Injection

PLACEBO COMPARATOR

Drug: 5% Glucose Injection

Interventions

Shenfu Injection DRUG

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.

Shenfu Injection

5% Glucose Injection DRUG

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.

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 scheduled for primary PCI.
• ST segment elevation in at least two contiguous precordial leads according to electrocardiogram (\>30 min).
• Symptoms onset ≤12 hours.
• 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.
• Written informed consent.

You may not qualify if:

• Cardiogenic shock, serious heart failure (Killip class III or above), malignant ventricular arrhythmia, or mechanical complications.
• Post cardiopulmonary resuscitation (CPR) (including cardioversion).
• Patients who have received thrombolytic therapy or upstream GPIIb/IIIa inhibitors (GPI).
• Uncontrolled hypertension (systolic BP ≥180 mm Hg or a diastolic BP ≥110 mmHg).
• Prior myocardial infarction, PCI or coronary artery bypass graft.
• Known severe hepatic insufficiency (AST/ALT \>3-fold the upper limit of normal value) or known renal insufficiency.
• Malignant tumor, lymphoma, HIV-positive, or cirrhosis with life expectancy \<1 year.
• Patients with active bleeding, intracranial hemorrhage, major surgery or trauma within 1 months, or ischemic stroke or transient ischemic attack (TIA) within 6 months.
• History of anemia (hemoglobin\<90g/L) or thrombocytopenia (thrombocyte\<100×109/L).
• 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).
• Scheduled for CABG within one month after randomization.
• Pregnancy, lactation, 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 contraindication to CMR (metal foreign body in the body, claustrophobia, etc.).
• Participation in other clinical trial in recent 3 months.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

RECRUITING

Related Publications (1)

• Wang X, Guo R, Guo Y, Guo Q, Yan Y, Gong W, Zheng W, Wang H, Xu L, Ai H, Que B, Yan X, Ma X, Nie S. Rationale and design of the RESTORE trial: A multicenter, randomized, double-blinded, parallel-group, placebo-controlled trial to evaluate the effect of Shenfu injection on myocardial injury in STEMI patients after primary PCI. Am Heart J. 2023 Jun;260:9-17. doi: 10.1016/j.ahj.2023.02.005. Epub 2023 Feb 22.

  PMID: 36822255 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

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

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Central Study Contacts

Shao-Ping Nie, MD, PhD

CONTACT

86-10-84005256; spnie@ccmu.edu.cn

Xiao Wang, MD

CONTACT

86-10-84005255; spaceeye123@126.com

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: Professor of Medicine, Director, Emergency & Critical Care Center

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 30, 2020
• Study Start: July 30, 2020
• Primary Completion: July 31, 2022
• Study Completion: August 31, 2022
• Last Updated: September 10, 2021

Record last verified: 2021-09

Locations

CN (1)