跳至主要内容
临床试验/CTRI/2023/11/059574
CTRI/2023/11/059574招募中不适用

Influence of Covid-19 infection and vaccination on coronary artery disease and its risk factors: An artificial intelligence based study

Dr Raghavendra U1 个研究点 分布在 1 个国家目标入组 1,800 人开始时间: 2023年11月13日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,800
试验地点
1
主要终点
The proportion of Coronary Artery Disease

研究概览

简要总结

After IEC clearance and CTRI registration, this prospective observational study will be conducted. Patients who are undergoing coronary angiogram and who meet the inclusion criteria will be included in this study. Informed consent will be obtained prior to the recruitment. Brief details of the patient’s demographic and clinical history are obtained. This includes age, gender, weight, height, and comorbidity history related to cardiovascular diseases. Further, a brief history is taken regarding COVID 19- infection and vaccination details. COVID-19 infection is confirmed based on verbal communication however, the severity of COVID-19 infection will be assessed based on documented evidence if any. If the participant does not know the vaccination details himself/herself, we intend to contact his/her relative personally, if not, telephonically to gather the information on COVID 19- infection and vaccination status. Blood test reports such as complete lipid profile, Hb, NT-Pro BNP, Troponin T, D-Dimer, CRP values are documented if present. Further, a few parameters are obtained from ECG, Treadmill stress test (TMT), Chest X-Ray, Echocardiogram, and CT-coronary angiogram if performed in them. These parameters include ST-T changes in ECG, test results of TMT, Ejection fraction and abnormal findings of the echocardiographic test, Heart failure changes in chest X-Ray, and Coronary calcium score from CT. All the parameters and data that are extracted are drawn from the tests that are routinely performed among patients undergoing coronary angiogram tests as a part of standard care. Meanwhile, Gensini score and Syntax scores are used in the severity assessment of the coronary artery using coronary angiogram. In addition, blood test parameters, ECG, Echo, TMT, CT and CAG parameters during COVID infection or before the COVID-19 era are also documented if available. A copy of 12 lead ECGs, Chest X-Ray images, Apical 4 chamber images from stored Echocardiographic data, and coronary angiogram recording will be taken for the creation of an automated diagnostic model.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients of age 18 years and above (have been vaccinated or not) Participants who are undergoing coronary angiogram at the Department of Cardiology Kasturba Hospital Manipal Able to read write and converse in English/Kannada.

排除标准

  • Participants who are not willing to give consent Patients with congenital heart disease Patients with known genetic diseases and related cardiomyopathies Patients with rheumatic heart diseases Patients with major psychiatric disorders, dementia or delirium.

结局指标

主要结局

The proportion of Coronary Artery Disease

时间窗: At the recruitment

Risk factors for Coronary artery disease

时间窗: At the recruitment

Determinants of Coronary artery disease

时间窗: At the recruitment

次要结局

  • Treadmil stress test findings(CT angio results)

研究者

发起方
Dr Raghavendra U
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Raghavendra U

Manipal Academy of Higher Education

研究点 (1)

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