Initiate Danhong Injection before or after percutaneous coronary intervention for microvascular obstruction in ST-elevation myocardial infarction (DIRECTION): study protocol for a randomized controlled trial

Abstract

on behalf of the DIRECTION investigatorsAbstract Background: No treatment has convincingly been proven to be beneficial for microvascular obstruction (MVO) in patients with ST-elevation myocardial infarction (STEMI). Several studies have described the effects of Danhong Injection. However, evidence of a rigorously designed verification study is still lacking, and the intervention timing of Danhong Injection is uncertain. Methods:The DIRECTION study is a multicenter, prospective, randomized, evaluator-blind study. A total of 336 patients with STEMI receiving percutaneous coronary intervention (PCI) will be randomly assigned to conventional treatment, the preoperative Danhong Injection, or the postoperative Danhong Injection. The primary outcome is rate of ST-segment resolution (STR) ≥ 70% at 90 min after PCI. The secondary outcomes are the degree of STR, Thrombolysis in Myocardial Infarction (TIMI) flow grade, TIMI myocardial perfusion grade, left ventricular ejection fraction, N-terminal prohormone brain natriuretic peptide, high-sensitivity C-reactive protein, and infarct size expressed as area under the curve for cardiac troponin I (cTnI) and for creatine kinase MB. The major adverse cardiovascular events and hospital readmission events will be recorded. Health quality will be assessed with the 12item Short Form Health Survey. The safety outcomes include bleeding events, adverse events, and abnormal changes in routine blood tests. Psychological status and dietary patterns will be evaluated using Hamilton Depression Rating Scale and Food Frequency Questionnaire as the relevant indicators. Discussion: This trial will evaluate the efficacy and safety of Danhong Injection, as well as its optimal timing of intervention to prevent MVO in patients with STEMI.

Revealing Calcium Signaling Pathway as Novel Mechanism of Danhong Injection for Treating Acute Myocardial Infarction by Systems Pharmacology and Experiment Validation

“…Studies had shown that salvianolic acid such as danshensu and salvianolic acid B had a protective effect on the heart of AMI, which was closely related to the inhibition of intracellular calcium pathways ( Chen et al, 2011 ; Wang et al, 2011 ; Zhao et al, 2012 ; Lin et al, 2016 ). In a cross-sectional study, Zhang et al, found that serum calcium concentrations were significantly lower in patients with first AMI compared with patients without AMI, further emphasizing the value of serum calcium level in clinical practice ( Zhang et al, 2020 ). Similarly, integrated bioinformatics studies revealed that the calcium signaling pathway plays an important role in AMI ( Guo et al, 2021a ).…”

Traditional Chinese Medicine for Coronary Artery Disease Treatment: Clinical Evidence From Randomized Controlled Trials

“…Inflammation and immune injury in SCAD have been proven (54), and whether Taoren Honghua Jian Granule (桃 仁 红 花 煎 颗 粒) could alleviate symptoms, control inflammation, and improve quality of life in patients with SCAD will also be explored (55). Other RCTs will reveal the efficacy and safety of Danhong Injection, as well as its optimal timing of intervention (before or after percutaneous coronary intervention) to prevent microvascular obstruction in patients with ST-segment elevation myocardial infarction (56), and determine the clinical efficacy and safety of traditional Chinese medicine Tongxinluo Capsule in the treatment of ST-segment elevation myocardial infarction patients in the reperfusion era (57).…”

Comparison of the Efficacy of Danhong Injections at Different Time-points During the Perioperative Period of Acute Myocardial Infarction: A Systematic Review and Meta-analysis of Randomized Controlled Trials

“…The effect of DHI in the perioperative period was previously assessed in a systematic review by Zhang et al, who concluded that DHI may improve reperfusion after PCI ( Zhang et al, 2020 ). After a meta-analysis of 1,131 patients in 12 studies, Yuan et al concluded that DHI can improve the perioperative cardiac function in patients with AMI and increase the TIMI blood flow grade ( Yuan et al, 2020 ).…”