ASSESMENT OF LEFT HEART FUNCTION BY STRAIN ECHO IN DIABETIC PATIENTS WITH RETINOPATHY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Ayush Sharma
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- To compare Left Ventricular & Left Atrial Strain parameters using ECHO in diabetic patients with and without retinopathy and establish a co-relation
研究概览
简要总结
The study involves comparison of 2 groups of diabetic individuals, those with and those without diabetic retinopathy and the presence of left sided cardiac dysfunction in them by using strain ECHO parameters. It is an observational cross sectional study. Approximately 126 patients with 63 in each group (diabetic patients with retinopathy and other group of diabetic patients without retinopathy) will be participating in the study after explaining to them about the study and taking their informed consent. Patients will be subjected to routine history taking and a general physical examination along with routine blood investigations like glycosylated hemoglobin, Fasting blood sugars, Fasting lipid profile, Post prandial blood sugars, urine routine examination and urine protein to creatine ration. And routine non invasive investigations like a fundoscopy. Apart from this these patients will undergo a routine ECHO cardiography, ECG to fullfil the inclusion and exclusion criteria. Then the patients will be subjected to a strain ECHO in which various parameters as mentioned in the proforma for assessment of Left sided heart failure will be assesed. The outcome will then be compared in the form of presence and association of left sided cardiac dysfunction with diabetic retinopathy and nephropathy.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Males and Females above the age of 18 years living with Type 2 diabetes Mellitus willing to be evaluated for Retinopathy, and to undergo a cardiac evaluation by strain ECHO between August 2022 to August 2024.
排除标准
- •Known Coronary Artery disease.
- •Newly diagnosed Coronary artery disease by non invasive tests such as ECHO/ Tread mill test.
- •Pre-existing Congestive cardiac failure.
- •Moderate to severe valvular heart disease.
- •Pre-existing Occular anomalies, like eyeball tumours, occular trauma, enucleation of eyes.
- •Left ventricular Ejection Freaction of less than 50 percent.
- •Chronic Kidney Disease (grade 2 or above).
- •Poor window prohibiting strain ECHO analysis.
结局指标
主要结局
To compare Left Ventricular & Left Atrial Strain parameters using ECHO in diabetic patients with and without retinopathy and establish a co-relation
时间窗: At the end of sample collection
次要结局
- To corelate findings of Strain ECHO parameters acreoss stages of Diabetic Nephropathy(Once data collection is complete & sample size is achieved the primary outcome will be measured)