ABSTRACT
BACKGROUND@#Ventricular remodeling after acute anterior wall ST-segment elevation myocardial infarction (AAMI) is an important factor in occurrence of heart failure which additionally results in poor prognosis. Therefore, the treatment of ventricular remodeling needs to be further optimized. Compound Danshen Dripping Pills (CDDP), a traditional Chinese medicine, exerts a protective effect on microcirculatory disturbance caused by ischemia-reperfusion injury and attenuates ventricular remodeling after myocardial infarction.@*OBJECTIVE@#This study is designed to evaluate the efficacy and safety of CDDP in improving ventricular remodeling and cardiac function after AAMI on a larger scale.@*METHODS@#This study is a multi-center, randomized, double-blind, placebo-controlled, parallel-group clinical trial. The total of 268 patients with AAMI after primary percutaneous coronary intervention (pPCI) will be randomly assigned 1:1 to the CDDP group (n=134) and control group (n=134) with a follow-up of 48 weeks. Both groups will be treated with standard therapy of ST-segment elevation myocardial infarction (STEMI), with the CDDP group administrating 20 tablets of CDDP before pPCI and 10 tablets 3 times daily after pPCI, and the control group treated with a placebo simultaneously. The primary endpoint is 48-week echocardiographic outcomes including left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume index (LVEDVI), and left ventricular end-systolic volume index (LVESVI). The secondary endpoint includes the change in N terminal pro-B-type natriuretic peptide (NT-proBNP) level, arrhythmias, and cardiovascular events (death, cardiac arrest, or cardiopulmonary resuscitation, rehospitalization due to heart failure or angina pectoris, deterioration of cardiac function, and stroke). Investigators and patients are both blinded to the allocated treatment.@*DISCUSSION@#This prospective study will investigate the efficacy and safety of CDDP in improving ventricular remodeling and cardiac function in patients undergoing pPCI for a first AAMI. Patients in the CDDP group will be compared with those in the control group. If certified to be effective, CDDP treatment in AAMI will probably be advised on a larger scale. (Trial registration No. NCT05000411).
Subject(s)
Humans , ST Elevation Myocardial Infarction/therapy , Stroke Volume , Ventricular Remodeling , Prospective Studies , Microcirculation , Ventricular Function, Left , Myocardial Infarction/etiology , Treatment Outcome , Percutaneous Coronary Intervention/adverse effects , Heart Failure/drug therapy , Drugs, Chinese Herbal/therapeutic use , Randomized Controlled Trials as Topic , Multicenter Studies as TopicABSTRACT
Objective To investigate the prediction by intravascular ultrasound (IVUS) with monocyte to high density lipoprotein-cholesterol (HDL-C) ratio (MHR) of 12-month prognosis in patients with intermediate non-left main coronary lesions after percutaneous coronary intervention (PCI). Methods Patients with intermediate non-left main coronary lesions diagnosed by coronary angiography were tested of monocyte counts and HDL-C levels at admission with MHRs calculated. IVUS was used to examine plaque stability in target lesions. Patients were dviided into stable plaque group (n=44) and unstable plaque group (n=140) according to the IVUS results. PCI was then operated in patients with unstable plaque or with minimum lumen area<4 mm2. The major adverse cardiovascular events (MACE) were recorded during the follow-up period of 12 months after PCI. Results MHR was significantly higher in unstable plaque group than that in stable plaque group[(22.6±8.4) vs.(14.1±7.2),P<0.001]. Receiver-operating characteristic (ROC) analysis revealed that an MHR cut-off of 16.05 had 74.2％ sensitivity and 77.0％ specificity for prediction of 12-month MACE after PCI (AUC 0.78, 95％ CI 0.71–0.85, P<0.001). Besides, unstable plaque with MHR over 16.05 was an independent risk factor for 12-month MACE after PCI (adjusted HR 3.26, 95％ CI 2.48–4.14, P=0.020). Conclusions IVUS combined with MHR is a valuable index predicting the prognosiso f patients with intermediate non-left main coronary lesions who underwent PCI.
ABSTRACT
<p><b>BACKGROUND</b>Early goal-directed therapy (EGDT) has become an important therapeutic management in early salvage stage of septic shock. However, splenic organs possibly remained hypoperfused and hypoxic despite fluid resuscitation. This study aimed to evaluate the effect of EGDT on hepatic perfusion in septic shock patients.</p><p><b>METHODS</b>A prospective observational study was carried out in early septic shock patients who were admitted to Intensive Care Unit within 24 h after onset and who met all four elements of the EGDT criteria after treatment with the standard EGDT procedure within 6 h between December 1, 2012 and November 30, 2013. The hemodynamic data were recorded, and oxygen metabolism and hepatic functions were monitored. An indocyanine green clearance test was applied to detect the hepatic perfusion. The patients' characteristics were compared before treatment (T0), immediately after EGDT (T1), and 24 h after EGDT (T2). This study is registered at ClinicalTrials.org, NCT02060773.</p><p><b>RESULTS</b>Twenty-one patients were included in the study; however, the hepatic perfusion data were not included in the analysis for two patients; therefore, 19 patients were eligible for the study. Hemodynamics data, as monitored by pulse-indicator continuous cardiac output, were obtained from 16 patients. There were no significant differences in indocyanine green plasma disappearance rate (ICG-PDR) and 15-min retention rate (R15) at T0 (11.9 ± 5.0%/min and 20.0 ± 13.2%), T1 (11.4 ± 5.1%/min and 23.6 ± 14.9%), and T2 (11.0 ± 4.5%/min and 23.7 ± 15.3%) (all P > 0.05). Both of the alterations of ICG-PDR and R15 showed no differences at T0, T1, and T2 in the patients of different subgroups that achieved different resuscitation goal numbers when elected (P > 0.05).</p><p><b>CONCLUSION</b>There were no hepatic perfusion improvements after EGDT in the early phase of patients with septic shock.</p><p><b>TRIAL REGISTRATION</b>Clinicaltrials.gov NCT02060773 (https://clinicaltrials.gov/ct2/show/NCT02060773).</p>