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临床试验/CTRI/2025/10/095629
CTRI/2025/10/095629尚未招募不适用

Study Of Clinical and Imaging Profile of Non Ischaemic Cardiomyopathy

Dr. Shivam Goel1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2025年10月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
62
试验地点
1
主要终点
To evaluate the clinical characteristics and imaging findings in patients with non-ischemic cardiomyopathy (NICM), with the aim of identifying key diagnostic markers, patterns of disease progression, and risk factors for adverse outcomes such as arrhythmias, sudden cardiac death, and advanced heart failure.

研究概览

简要总结

The proposed study, titled “Study of Clinical and Imaging Profile of Non-Ischaemic Cardiomyopathy (NICM)”, is a cross-sectional study planned to be conducted at Kasturba Hospital, Manipal, between September 2025 and September 2027. The aim is to evaluate the clinical and imaging profiles of different types of NICM, determine their underlying causes, and explore the correlation between imaging findings and clinical presentations to enhance risk prediction, prognosis, and management strategies. A total of 62 patients will be enrolled, calculated based on a 10% prevalence of dilated cardiomyopathy using Lemeshow’s formula. Adults over 18 years diagnosed with various forms of NICM, such as alcoholic, peripartum, dilated, hypertrophic, arrhythmogenic, restrictive, and Takotsubo cardiomyopathy, will be included, while patients with ischemic cardiomyopathy, significant valvular or congenital heart disease, hypertensive heart disease, chronic kidney disease, or acute systemic causes of heart failure will be excluded. Participants will be recruited from outpatient and inpatient departments, and data will be collected through clinical interviews, laboratory investigations (e.g., NT Pro-BNP, Trop-T, CRP), and advanced imaging techniques such as ECG, echocardiography, cardiac MRI, CT angiogram, PET CT, SPECT, and endomyocardial biopsy as needed. Statistical analysis will be performed using SPSS v23, employing appropriate tests based on data distribution. The study has minimal risks, limited to patient anxiety or missing data, and is expected to provide significant benefits by enabling personalized treatment plans, improving the prediction of complications like arrhythmias, sudden cardiac death, and severe heart failure, and enhancing understanding of disease phenotypes. Ethical clearance, CTRI registration, and informed consent will be obtained before initiation. This research is of national importance as it addresses the gaps in understanding NICM, validates newer diagnostic criteria, and leverages advanced imaging to optimize patient outcomes.

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

  • Diagnosed case of Cardiomyopathy (outpatient and inpatient) including Alcoholic Cardiomyopathy Peripartum Cardiomyopathy Dilated Cardiomyopathy Hypertrophic Cardiomyopathy Arrhythmogenic Cardiomyopathy Restrictive Cardiomyopathy Takotsubo Cardiomyopathy.

排除标准

  • Patient with known Ischaemic Cardiomyopathy Acute alcoholic cardiomyopathy- Wet beri beri Chronic kidney Disease Acute decompensated heart disease due to systemic disease/ sepsis Significant valvular heart disease Hypertensive heart disease Congenital heart disease.

结局指标

主要结局

To evaluate the clinical characteristics and imaging findings in patients with non-ischemic cardiomyopathy (NICM), with the aim of identifying key diagnostic markers, patterns of disease progression, and risk factors for adverse outcomes such as arrhythmias, sudden cardiac death, and advanced heart failure.

时间窗: 2 Years

次要结局

未报告次要终点

研究者

发起方
Dr. Shivam Goel
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Shivam Goel

Kasturba Medical College, Manipal

研究点 (1)

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