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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.
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:
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.
Inclusion criteria:
Signed informed consent;
Age 18 - 80 years old.
Diagnosis:
Exclusion criteria:
Exclusion criteria:
Primary endpoint (combined):
Secondary endpoints:
Any decrease in body weight (weight, BMI) any decrease in waist circumference. 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.
Randomization by means of envelopes.
It is planned to create in advance a database of identification numbers (hereinafter - ID) in the amount corresponding to the planned set of patients (950 ID). Further, these numbers will be divided into two groups with an equal number of IDs in each:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemonitoring group | The telemonitoring group will be connected to electronic medical systems, through which medical workers will remotely assess clinical and emotional status, adherence to drug therapy, and carry out nutritional adjustments. | ||
| Control group | Patients with standard administration. |
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| Measure | Description | Time Frame |
|---|---|---|
| Death or rehospitalizations Primary endpoint A | Death from cardiovascular causes and / or rehospitalizations for cardiovascular pathology | Upon completion, up to 6 months |
| Emergency or urgent care without hospitalization | The number of episodes requiring emergency or urgent care without hospitalization (calls to the ambulance for complaints from the cardiovascular system) | Upon completion, up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life according to the HeartQol questionnaire. | Health-related quality of life, symptoms, and functional status make up patient-reported outcomes | Upon completion, up to 6 months |
| Commitment to outpatient monitoring |
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Inclusion Criteria:
Signed informed consent;
Age 18 - 80 years old.
Diagnosis:
Exclusion Criteria:
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Patients with acute coronary syndrome who have undergone the hospital stage of treatment are included in the study at the time of discharge. And then, at the outpatient stage after randomization, the first group receives standard assistance together with telemonitoring support, the second group - standard offline medical assistance.
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| Name | Affiliation | Role |
|---|---|---|
| Sergey Morozov | Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City Clinical Hospital No. 13 of the Moscow City Health Department | Moscow | 115280 | Russia |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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Commitment to outpatient monitoring - is determined by the number of participants who voluntarily left the study, by the percentage of results obtained - surveys in electronic form.
| Upon completion, up to 6 months |
| Tolerance to physical activity | Tolerance to physical activity (any increase in walking distance according to 6MWT, VEM according to indications). | Upon completion, up to 6 months |
| Decrease in body weight | Any decrease in body weight (weight, BMI) any decrease in waist circumference. | Upon completion, up to 6 months |