BackgroundPatients with ST-segment elevation myocardial infarction (STEMI) experience major adverse cardiac events (MACEs) following primary percutaneous coronary intervention (PCI). Although the relationship between time to treatment (eg, door-to-balloon time, symptom onset-to-balloon time, and symptom onset-to-door time) and 1-month all-cause mortality was assessed previously, its relationship with in-hospital MACEs and the effect of some clinical characteristics on this relationship were not considered. Furthermore, previous studies that were conducted in developed countries with a different quality of care cannot be applied in Iran, as Iran is a developing country and the studies were not performed according to the 24/7 primary PCI service registry.ObjectiveThe objective of this study protocol is to determine the relationship between time to treatment and in-hospital MACEs.MethodsThis cross-sectional study will take place at the Tehran Heart Center (THC), which is affiliated with Tehran University of Medical Sciences (TUMS) in Tehran, Iran. Data related to patients with STEMI, who underwent primary PCI between March 2015 and March 2019, that have been prospectively recorded in the THC’s 24/7 primary PCI service registry will be analyzed. The study outcome is the occurrence of in-hospital MACEs. Data analysis will be conducted using SPSS for Windows, version 16.0 (SPSS Inc). We will perform chi-square tests, independent-samples t tests, or the Mann-Whitney U test, as well as univariate and multivariate binary logistic regression with a significance level of less than .05 and 95% CI for odds ratios.ResultsFrom March 2015 to September 2017, 1586 patients were included in the THC service registry, consecutively. We will conduct a retrospective analysis of this registry on patient entries between March 2015 and March 2019 and data will be analyzed and published by the end of 2019.ConclusionsTo our knowledge, this is the first observational study based on the 24/7 primary PCI service registry in Iran. The findings of this study may reveal current problems regarding time to treatment in STEMI management in the THC. Results from this study may help determine appropriate preventive strategies that need to be applied in order to reduce time-to-treatment delays and improve patients’ outcomes following primary PCI in the setting of STEMI at the THC and similar clinical centers.International Registered Report Identifier (IRRID)DERR1-10.2196/13161
BackgroundPatients with heart failure (HF) reduced ejection fraction (HFrEF) have symptoms that are more severe and experience a higher rate of hospitalization compared with HF preserved ejection fraction (HFpEF) patients. However, symptom recognition cannot be made by patients based on current approaches. This problem is a barrier to effective self-care that needs to be improved by new self-monitoring instruments and strategies.ObjectiveThis study describes a protocol for the self-monitoring daily diaries of weight and shortness of breath (SOB) based on the traffic light system (TLS). The primary objective is to compare the self-care between the intervention and control group. Comparison of HF knowledge, HF quality of life (HFQOL), and all-cause hospitalization between the 2 groups are the secondary objectives.MethodsA single-blind randomized controlled trial is being conducted at the HF clinic at Tehran Heart Center (Tehran, Iran). Sixty-eight adult patients of both genders will be enrolled during admission to HF clinic. Eligible subjects will be assigned to either the intervention or control group by a block balanced randomization method. Baseline surveys will be conducted before random allocation. Participants in the intervention group will receive an integrated package consisting of (1) HF self-care education by an Australian Heart Foundation booklet on HF, (2) regular home self-monitoring of weight and SOB, and (3) scheduled call follow-ups for 3 months. Patients in the control group will receive no intervention and they only complete monthly surveys.ResultsThis study is ongoing and is expected to be completed by the end of 2018.ConclusionsThis is the first trial with new self-monitoring instruments in Iran as a low and middle-income country. If the findings show a positive effect, the package will be applied in different regions with the same health care status.Trial RegistrationIranian Registry of Clinical Trials IRCT2017021032476N1; https://en.irct.ir/trial/25296?revision=25296 (Archived by WebCite at http://www.webcitation.org/73DLICQL8)International Registered Report Identifier (IRRID)PRR1-10.2196/9209
Background: Heart failure (HF) is a serious problem with an increasing prevalence globally. Low level of HF knowledge may cause low compliance and low quality of life and, poor self-care. On the other hand, assessing the level of HF knowledge is necessary in order to apply educational programs. Aims and objectives: the aim was to determine knowledge regarding HF among Iranian patients with HF. Study Design: This was a cross sectional study. Setting: We conducted this study at the HF clinic of Tehran Heart Center (THC) affiliated with Tehran University of Medical Sciences (TUMS, Tehran, Iran). Materials and Methods: In this cross-sectional study, 190 patients older than 18 years old, with confirmed diagnosis of HF for at least 3 months by an HF specialist, NYHA function class II to IV and an ability of reading and writing Farsi language were included during June 2017 and January 2018 by consecutive sampling. Data were gathered in a short form, including demographic and clinical variables. Knowledge regarding HF was measured by the Dutch HF knowledge scale (Cronbach’s alpha=0.62) with 15- multiple choice item. The score range varied between 0 (no knowledge) and 15 (optimum knowledge). Scores were reported totally and in 3 areas of knowledge. Scores higher than the median was considered as higher knowledge. Statistics: The SPSS software version 16 was used to describe data. Normality of continuous variables was checked by the Kolmogorov-Smirnoff test. Frequency and partial frequency distribution were used to describe Categorical variables. While, we used mean, median, standard deviation, and IQR for describing continuous variables. Results: From June 2017 to January 2018, 160/190 patients with median age (IQR) of 59 (16) years old participated in the study (response rate of 84.2%). 67.5% of study patients were male (83.5%). 87.5% of then were married. The majority of patients were with NYHA function class II (60.6%), and with an etiology of ischemic heart disease (65.0%). The median and IQR of total, general, HF treatment, and symptoms/ symptom recognition knowledge were 8 (7-10), 12 (9-14), 2 (1.25-3), and 4 (3-5), respectively. Low level of total, general, HF treatment, and symptoms and symptom recognition knowledge among Iranian patients with HF were 55%, 60%, 58.8%, and 71.9%, respectively. Conclusion: Patients with HF had low levels of total, general, HF treatment, and symptoms/symptom recognition knowledge. Thus, there is an essential need to be improved by an appropriate intervention, especially on knowledge of symptoms /symptom recognition.
Background Performing primary percutaneous coronary intervention (PCI) as a preferred reperfusion strategy for patients with ST-segment elevation myocardial infarction (STEMI) may be associated with major adverse cardiocerebrovascular events (MACCEs). Thus, timely primary PCI has been emphasized in order to improve outcomes. Despite guideline recommendations on trying to reduce the door-to-balloon time to <90 minutes in order to reduce mortality, less attention has been paid to other components of time to treatment, such as the symptom-to-balloon time, as an indicator of the total ischemic time, which includes the symptom-to-door time and door-to-balloon time, in terms of clinical outcomes of patients with STEMI undergoing primary PCI. Objective We aimed to determine the association between each component of time to treatment (ie, symptom-to-door time, door-to-balloon time, and symptom-to-balloon time) and in-hospital MACCEs among patients with STEMI who underwent primary PCI. Methods In this observational study, according to a prospective primary PCI 24/7 service registry, adult patients with STEMI who underwent primary PCI in one of six catheterization laboratories of Tehran Heart Center from November 2015 to August 2019, were studied. The primary outcome was in-hospital MACCEs, which was a composite index consisting of cardiac death, revascularization (ie, target vessel revascularization/target lesion revascularization), myocardial infarction, and stroke. It was compared at different levels of time to treatment (ie, symptom-to-door and door-to-balloon time <90 and ≥90 minutes, and symptom-to-balloon time <180 and ≥180 minutes). Data were analyzed using SPSS software version 24 (IBM Corp), with descriptive statistics, such as frequency, percentage, mean, and standard deviation, and statistical tests, such as chi-square test, t test, and univariate and multivariate logistic regression analyses, and with a significance level of <.05 and 95% CIs for odds ratios (ORs). Results Data from 2823 out of 3204 patients were analyzed (mean age of 59.6 years, SD 11.6 years; 79.5% male [n=2243]; completion rate: 88.1%). Low proportions of symptom-to-door time ≤90 minutes and symptom-to-balloon time ≤180 minutes were observed among the study patients (579/2823, 20.5% and 691/2823, 24.5%, respectively). Overall, 2.4% (69/2823) of the patients experienced in-hospital MACCEs, and cardiac death (45/2823, 1.6%) was the most common cardiac outcome. In the univariate analysis, the symptom-to-balloon time predicted in-hospital MACCEs (OR 2.2, 95% CI 1.1-4.4; P=.03), while the symptom-to-door time (OR 1.4, 95% CI 0.7-2.6; P=.34) and door-to-balloon time (OR 1.1, 95% CI 0.6-1.8, P=.77) were not associated with in-hospital MACCEs. In the multivariate analysis, only symptom-to-balloon time ≥180 minutes was associated with in-hospital MACCEs and was a predictor of in-hospital MACCEs (OR 2.3, 95% CI 1.1-5.2; P=.04). Conclusions A longer symptom-to-balloon time was the only component associated with higher in-hospital MACCEs in the present study. Efforts should be made to shorten the symptom-to-balloon time in order to improve in-hospital MACCEs. International Registered Report Identifier (IRRID) RR2-10.2196/13161
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