Transplantation of mesenchymal stem cells for prevention of acute myocardial infarction induced heart failure: study protocol of a phase III randomized clinical trial (Prevent-TAHA8).

BACKGROUND: Results from recent clinical trials on bone marrow mononuclear cell (BM-MNC) transplantation show that this intervention can help reduce the incidence of heart failure (HF) after acute myocardial infarction (AMI). However, no study has evaluated the effect of the transplantation of mesenchymal stem cells (MSCs) on a clinical endpoint such as HF. METHODS: This single-blinded, randomized, multicenter trial aims to establish whether the intracoronary infusion of umbilical cord-derived Wharton's jelly MSCs (WJ-MSCs) helps prevent HF development after AMI. The study will enroll 390 patients 3 to 7 days following AMI. Only patients aged below 65 years with impaired LV function (LVEF < 40%) will be included. They will be randomized (2:1 ratio) to either receive standard care or a single intracoronary infusion of 107 WJ-MSCs. The primary outcome of this study is the assessment of HF development during long-term follow-up (3 years). DISCUSSION: Data will be collected until Nov 2024. Thereafter, the analysis will be conducted. Results are expected to be ready by Dec 2024. We will prepare and submit the related manuscript following the CONSORT guidelines. This study will help determine whether or not the infusion of intracoronary WJ-MSCs in patients with AMI will reduce the incidence of AMI-induced HF. TRIAL REGISTRATION: ClinicalTrials.gov NCT05043610 , Registered on 14 September 2021 - retrospectively registered.

Single vs. double intracoronary injection of mesenchymal stromal cell after acute myocardial infarction: the study protocol from a randomized clinical trial: BOOSTER-TAHA7 trial.

BACKGROUND: Meta-analysis from previous studies have shown that treatment with mesenchymal stromal cell (MCSs) may increase the left ventricular ejection fraction (LVEF) after acute myocardial infarction (AMI) by 3.84%, and the effect is greater in those who are not aged and have developed a reduced LVEF. However, it seems that MSC transplantation does its effect through an indirect paracrine effect, and direct differentiation to the cardiomyocytes does not occur. Therefore, it can be hypothesized that this paracrine effect would be augmented if repeated doses of MSC are transplanted. This study is conducted to compare single vs. double injection of MSCs. METHODS: This is a single-blind, randomized, multicenter trial aiming to determine whether intracoronary infusion of double doses of umbilical cord-derived Wharton's jelly MSCs (WJ-MSCs) improves LVEF more after AMI compared to single administration. Sixty patients 3 to 7 days after AMI will be enrolled. The patients should be under 65 years old and have a severe impairment in LV function (LVEF < 40%). They will be randomized to three arms receiving single or double doses of intracoronary infusion of WJ-MSCs or placebo. The primary endpoint of this study is assessment of improvement in LVEF at 6-month post intervention as compared to the baseline. DISCUSSION: This investigation will help to determine whether infusion of booster (second) dose of intracoronary WJ-MSCs in patients with AMI will contribute to increasing its effect on the improvement of myocardial function. TRIAL REGISTRATION: Iranian Registry of Clinical Trials ( www.IRCT.ir ) IRCT20201116049408N1. Registered on November 26 2020.

Efficacy of education delivery through multimedia and text messaging on the psychological parameters of patients scheduled for coronary angiography: a single-blind randomized controlled clinical trial.

BACKGROUND: Angiography is a highly effective invasive method for diagnosing coronary artery diseases but can lead to certain psychological problems such as stress, anxiety, and depression. This study aimed to compare the effects of education delivery through multimedia DVD content or text messaging in comparison with conventional printed pamphlets on the psychological parameters of patients scheduled for angiography. METHODS: This study was a randomized controlled clinical trial. We used the convenience sampling method to select 120 patients who met the inclusion criteria among individuals who were scheduled for elective coronary angiography. The patients were randomly divided into three groups through the block randomization method. The necessary educational tips for before, during, and after the angiography procedure were delivered to the patients in interventional group 1 (n = 40) and interventional group 2 (n = 40) through text messages and a multimedia DVD, respectively. The control group received routine hospital education through pamphlets besides the opportunity for verbal discussions with nurses. All educational content was delivered to the patients four days before the scheduled day of angiography. The DASS-21 questionnaire, consisting of the three domains of stress, anxiety, and depression, was used to collect the data. The questionnaire was administered at the time of delivering the educational content as the pretest evaluation and 30 min after the angiography procedure as the posttest evaluation. SPSS software, version 18, was used for statistical analysis. RESULTS: There was no significant difference among the three groups of patients in terms of pretest DASS-21 scores. Conversely, the mean posttest scores in all DASS-21 domains were significantly lower among the patients receiving education via the multimedia DVD or text messaging in comparison with the control group (P < 0.001). However, there were no statistically significant differences between the mean scores in all domains between the participants in the DVD and text messaging groups. CONCLUSION: It seems that both DVDs and text messaging are more effective than conventional pamphlets in controlling the anxiety, stress, and stress of patients scheduled for elective coronary artery angiography. Iranian Registry of Clinical Trials: IRCT registration number: IRCT2015030121283N1, Registration date: 2015-10-05, 1394/07/13.

The impact of generic form of Clopidogrel on cardiovascular events in patients with coronary artery stent: results of the OPCES study.

BACKGROUND: To compare the early and late cardiovascular events as well as side effects of Osvix, a generic form of Clopidogrel versus Plavix regimens in patients with chronic stable angina, undergoing bare metal stent (BMS) or drug eluting stent (DES) placement, this study was carried out. METHODS: A total of 442 patients with chronic stable angina who were scheduled for elective percutaneous coronary intervention (PCI) were included in a randomized, double blind, multi-centric clinical trial being performed in 6 distinct university hospitals in 5 cities of Iran from March 2007 to November 2009. Baseline, demographic and history of risk factors were recorded using the patients' medical charts. Stenting procedure was performed via transfemoral approach using low osmolar contrast agents. Patients underwent BMS or DES placements based on the physician selection and were randomly assigned to Osvix or Plavix groups. Patients were followed by telephone in 0 and 6 months intervals regarding the major adverse cardiovascular events (MACE) including death, myocardial infarction, in-stent thrombosis, stroke, target lesion revascularization, and target vascular revascularization. Angina episodes, bleeding, liver enzymes, neutrophils and platelets count were also assessed in these intervals. RESULTS: There was not any significant difference between these two groups regarding the baseline characteristics. In the DES group, the 6-month mortality rate and the incidence of MACE in Osvix and Plavix groups were 0.9% and 1.9% (p = 0.61) and 1.8% and 4.9% (p = 0.26), respectively. During the follow up period after DES or BMS placement, there wasn't any significant difference regarding neutrophil and platelet counts or liver enzymes between study groups. CONCLUSIONS: Using Osvix and Plavix are followed by similar major cardiovascular events and side-effect profile in patients undergoing PCI.