Clinical profile of arrhythmias post acute myocardial infarction in the first 48hours
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Association between acute myocardial Infarction and arrhythmias in the first 48hours.
研究概览
简要总结
Arrhythmias, may occur at any time of myocardial infarction, beginning from the early minutes of acute infarction till the remote post-MI period.Although the incidence of VAs has declined in the hospital phase of acute coronary syndromes (ACS) mainly due to prompt revascularization and early introduction of optimal medical therapy, the risk of cardiac arrest and sudden cardiac death (SCD) remains increased after MI and are predictors of worse in-hospital outcome in the setting of ACS.
Need for the study:
Risk factors if identified, helps in risk stratification, primary prevention and early intervention thereby reducing the morbidity and mortality associated with arrhythmias, which are a major cause of death in the early (<48hrs) post acute myocardial infarction period.
Description:
A total of 196 participants will be recruited in the study after written informed consent ,using a preformed proforma, clinical, laboratory and imaging parameters will be collected from patients’ fitting the inclusion criteria. The parameters will be noted and relevant statistical analysis will be done to find correlation between acute myocardial Infarction and arrhythmias. The study will go on for 18months.
Detailed description of procedure / processes: After written informed consent ,using a preformed proforma, clinical, laboratory and imaging parameters will be collected from patients’ fitting the inclusion criteria.
1.Categorical variables will be expressed as frequency/percentage and will be compared using chiâ€square test.
2.Continuous variables with normal distribution will be presented as mean ± standard deviation (SD)-compared using unpaired t test. Nonâ€normally distributed data will be expressed as median and interquartile range (IQR)-compared using Mann Whitney U test. 3.Multivariate logistic regression analysis will be performed to identify independent risk factors. A pâ€value < 0.05 will be considered statistically significant for all tests.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients presenting with acute myocardial infarction above 18 years of age who can give written informed consent.
- •Acute myocardial infarction (MI) : Acute myocardial injury with clinical evidence of acute myocardial ischemia and with detection of a rise and,or fall of cT values with at least one value above the 99th percentile URL and at least one of the following: 1)Symptoms of myocardial ischemia 2)New ischemic electrocardiographic (ECG) changes 3) Development of pathologic Q waves 4)Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology.
排除标准
- •Pregnant females 2)History of prior myocardial infarction or chronic heart failure 3)Patients already on anti arrhythmics or drugs prolonging QT interval 4)Patients with previously diagnosed structural and valvular heart diseases- cardiomyopathy, congenital heart 5)Patients with previously diagnosed channelopathies or conduction disorders 6)Patient on cardiac device therapy 7)Prior documented cardiac conduction abnormalities 8)Documented Active infection 9)Autoimmune diseases 10)Malignancy 11)Chronic obstructive pulmonary disease 12)Hypothyroidism 13)Hyperthyroidism 14)Documented Anemia 15)Patients on Beta blockers.
结局指标
主要结局
Association between acute myocardial Infarction and arrhythmias in the first 48hours.
时间窗: At the time of recruitment.
次要结局
- To analyze risk factors associated with increased occurrence of arrhythmias post acute MI(Evaluation of ECG indices associated with arrhythmias post acute MI in the first 48hours)
研究者
Dr Sreeja Gandamsetty
Kasturba Medical College, Manipal