Objective Myocardial perfusion imaging (MPI) by gated single-photon emission computed tomography (SPECT) is a feasible method in the evaluation of left ventricular perfusion and function. The purpose of this study was to determine the threshold and grading of left ventricular (LV) diastolic dysfunction (LVDD) using gated SPECT MPI. Methods A total of 149 patients were recruited in the study. All of the patients underwent a standard 2-day stress/rest gated MPI study and transthoracic echocardiography within 2 weeks. The reconstructed rest-only images were analyzed by Cedar-Sinai’s quantitative gated SPECT and the LV diastolic parameters, including peak filling rate (PFR), time to PFR (TTPF) and secondary PFR (PFR2) to PFR ratio were provided and compared to echocardiographic data. Results 68 (45.6%) and 81 (54.4%) of patients were categorized in LVDD-absent and LVDD-present groups on the basis of LVDD evidence in echocardiography, respectively. receiver-operating-characteristic analysis for PFR and TTPF was performed, resulting in diagnostic sensitivities of 70 and 57% and specificities of 60 and 75% for PFR <2.6 end-diastolic volumes (EDV)/s and TTPF>160.5 ms, respectively. Applying our previously used thresholds of <1.70 EDV/s for PFR, >208 ms for TTPF and >1 for PFR2/PFR, sensitivities and specificities of 9.9 and 96.6%, 9.9 and 95.6% and 13.8 and 88% were resulted, respectively. Grading of LVDD on the basis of MPI-obtained diastolic parameters showed considerable overlapping data by interquartile range. Conclusion Gated SPECT MPI can be used as a highly specific means for detection of LV diastolic dysfunction when compared to echocardiography. However, grading of severity of diastolic heart failure appears to be impracticable.
Background The FAKHRAVAC®, an inactivated SARS-CoV-2 vaccine, was assessed for safety and immunogenicity in a phase II trial. Methods We did a phase II, single-centered, randomized, double-blind, placebo-controlled clinical trial of the FAKHRAVAC inactivated SARS-CoV-2 vaccine on adults aged 18 to 70. The two parallel groups received two intramuscular injections of either a 10-µg vaccine or a placebo at 2-week intervals. The participants' immunogenicity responses and the occurrence of solicited and unsolicited adverse events were compared over the study period of up to 6 months. Immunogenicity outcomes include serum neutralizing antibody activity and specific IgG antibody levels. Results Five hundred eligible participants were randomly (1:1) assigned to vaccine or placebo groups. The median age of the participants was 36 years, and 75% were male. The most frequent local adverse reaction was tenderness (21.29% after the first dose and 8.52% after the second dose), and the most frequent systemic adverse reaction was headache (11.24% after the first dose and 8.94% after the second dose). Neutralizing antibody titers two and four weeks after the second injection in the vaccine group showed about 3 and 6 times increase compared to the placebo group (GMR = 2.69, 95% CI 2.32–3.12, N:309) and (GMR = 5.51, 95% CI 3.94–8.35, N:285). A four-fold increase in the neutralizing antibody titer was seen in 69.6% and 73.4% of the participants in the vaccine group two and four weeks after the second dose, respectively. Specific ELIZA antibody response against a combination of S1 and RBD antigens 4 weeks after the second injection increased more than three times in the vaccine compared to the placebo group (GMR = 3.34, 95% CI 2.5–4.47, N:142). Conclusions FAKHRAVAC® is safe and induces a significant humoral immune response to the SARS-CoV-2 virus at 10-µg antigen dose in adults aged 18–70. A phase III trial is needed to assess the clinical efficacy. Trial registration: Trial Registry Number: Ref., IRCT20210206050259N2 (http://irct.ir; registered on 08/06/2021)
Background: Structural heart disease (SHD) has great impacts on healthcare systems, creating further public health concerns. Proper data are scant regarding the magnitude of the affected population by SHD. Objectives: This study aimed to determine the prevalence of SHD among children and adolescents in an Iranian population. Methods: In this population-based study, a multistage cluster-random sampling was used to choose schools from the Tehran urban area. All students were examined using a handheld Vscan device by echocardiographer, and the results were concurrently supervised and interpreted by cardiologists. All the major findings were reevaluated in hospital clinics. Results: Of 15,130 students (6–18 years, 52.2% boys) who were examined, the prevalence of individuals with congenital heart disease (CHD) and cardiomyopathy was 152 (10.046 per 1,000 persons) and 9 (0.595 per 1,000 persons), respectively. The prevalence of definite and borderline rheumatic heart disease (RHD) was 30 (2 per 1,000 persons) and 113 (7.5 per 1,000 persons), correspondingly. Non-rheumatic valvular heart disease (VHD) was also detected in 465 (30.7 per 1,000 persons) students. Of all the pathologies, only 39 (25.6%) cases with CHD and 1 (0.007%) cases with RHD had already been diagnosed. Parental consanguinity was the strongest predictor of CHD and SHD (odds ratio [OR]: 1.907, 95% CI, 1.358 to 2.680; P < 0.001 and OR, 1.855, 95% CI, 1.334 to 2.579; P < 0.001, respectively). The female sex (OR, 1.262, 95% CI, 1.013 to 1.573; P = 0.038) and fathers’ low literacy (OR, 1.872, 95% CI, 1.068 to 3.281; P = 0.029) were the strongest predictors of non-rheumatic VHD and RHD, correspondingly. Conclusions: The implementation of echocardiographic examinations for detecting SHD among young population is feasible which detected SHD prevalence in our population comparable to previous reports. Further studies are required to delineate its economic aspects for community-based screening.
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