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.

Psychometric properties of the Farsi translation of the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version.

BACKGROUND: Semi-structural clinical interviews are very important in the area of mental health research and services. There were no studies of the reliability and validity of the Farsi (Persian) version of Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version (K-SADS-PL) in Iran. This study compares the results of face-to-face, semi-structural interview and clinical interview by a child and adolescent psychiatrist. METHOD: Subjects were 109 children and adolescents recruited to the child and adolescent psychiatry outpatient clinic of Hafez Hospital. Order of interview (in-psychiatrist or the semi-structural interview) was determined using random assignment within a counterbalanced framework. After, translation and back translation of K-SADS-PL, the Farsi version of K-SADS-PL was provided and used in the study. The interviewer was unaware of the child and adolescent psychiatrist diagnosis at the time of making the interview. Consensual validity, test-retest and inter-rater reliability, sensitivity, specificity, positive and negative predictive validity for the disorders were studied. RESULTS: Consensual validity of all of the psychiatric disorders was good to excellent. It was highest for panic disorder, conduct disorder, and simple phobia. Consensual validity of anorexia nervosa was 0.49. There was sufficient validity and test-retest and inter-rater reliability and good to excellent sensitivity and specificity and positive and negative predictive validity for nearly all of the disorders. Test-retest reliabilities of attention deficit hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), and tic disorder were 0.81, 0.67, and 0.56; respectively. Inter-rater reliabilities of ADHD, and ODD were 0.69 and 0.69. Tic disorder, post traumatic disorder, panic disorder, and ADHD had the highest positive predictive validities. CONCLUSION: The Farsi version of K-SADS-PL is a valid and reliable interview instrument for use in assessing and diagnosing child and adolescent psychiatric disorders.