The Influence of Telemonitoring on the Development of Clinical Events and Improving the Quality of Life of Patients With Acute Coronary Syndrome (TeleCor)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 950
- 试验地点
- 1
- 主要终点
- Emergency or urgent care without hospitalization
研究概览
简要总结
It is planned to enroll 950 patients in an open, prospective, randomized study to assess the impact of telemonitoring on the development of clinical events and improve the quality of life of patients with acute coronary syndrome. The duration of the study is 365 days, of which 180 days are enrollment of patients, 180 days are observation. The study of patients will include the collection of anamnesis, assessment of the clinical status of patients using special questionnaires, data of objective, laboratory and instrumental examinations. The instrumental complex of the examination will include: electrocardiography (ECG), 6-minute walk test (6MWT), Holter ECG monitoring (HMECG), echocardiography, veloergometry (VEM), assessment of the actual nutrition Nutrilogic, autogeneration of an individual diet (Nutrilogic), weekly telemonitoring. Laboratory examination includes: biochemical blood test. The main objectives of the study are to study the effect of telemonitoring on mortality from cardiovascular diseases (CVD), as well as the number of readmissions for cardiovascular pathology in patients with ACS. The secondary endpoints of the study include quality of life as measured by the HeartQol questionnaire and adherence to ambulatory monitoring.
详细描述
Purpose of the study: to study the effect of telemonitoring on the development of clinical events and improving the quality of life of patients with ACS.
Research objectives:
- Improving the effectiveness of medical care in patients who have undergone ACS: increasing the level of compliance of patients, increasing the level of medical awareness of patients, reducing the number of unmotivated requests for medical care, reducing the time to achieve the observed targets, reducing the proportion of complications, reducing the number of destabilizing conditions with further inpatient treatment, optimization of the workload on medical personnel.
- Creation of a unified methodology for remote observation using telemedicine technologies in patients with ACS.
- Creation of a unified model of remote nutrition correction in patients after ACS.
Number of volunteers: statistically equivalent groups by sex and age, 950 subjects (475 per group). The number of volunteers who completed the study was 712 subjects (75% of the total number of patients).
365 days: 6 months enrollment, 6 months follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent;
- •Age 18 - 80 years old.
- •Diagnosis:
- •Acute myocardial infarction (I21.0, I21.1, I21.2, I21.3, I21.4, I21.9)
- •Unstable angina (I20.0) Recurrent myocardial infarction (I22.0, I22.1, I22.8, I22.9)
排除标准
- •Lack of technical equipment to connect to remote monitoring programs;
- •Severe cognitive dysfunction - dementia leading to maladjustment in everyday life;
- •Mental illness in the acute stage;
- •Oncological diseases requiring radiation and chemotherapy during the period of this study, as well as the corresponding stages of T3-4N2-3M1;
- •Lack of technical ability to take part in telemonitoring (do not have the skills to work on a smartphone, computer, tablet, there is no appropriate technical means);
- •Participation in other clinical studies to assess the effectiveness of pharmacological drugs;
- •Infection with SARS-CoV-2 with laboratory confirmation during the period of this study;
- •Acute coronary syndrome that developed in the hospital after surgery / intervention;
- •The emergence during observation of the need for surgical (not counting myocardial revascularization) or chemotherapy treatment;
- •Severe trauma (including craniocerebral) impeding observation according to the study protocol.
结局指标
主要结局
Emergency or urgent care without hospitalization
时间窗: Upon completion, up to 6 months
The number of episodes requiring emergency or urgent care without hospitalization (calls to the ambulance for complaints from the cardiovascular system)
Death or rehospitalizations Primary endpoint A
时间窗: Upon completion, up to 6 months
Death from cardiovascular causes and / or rehospitalizations for cardiovascular pathology
次要结局
- Quality of life according to the HeartQol questionnaire.(Upon completion, up to 6 months)
- Commitment to outpatient monitoring(Upon completion, up to 6 months)
- Tolerance to physical activity(Upon completion, up to 6 months)
- Decrease in body weight(Upon completion, up to 6 months)