Telemonitoring of Patients With Acute Coronary Syndrome

NCT04862026 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 950

Last updated 2023-04-10

No results posted yet for this study

Summary

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.

Conditions

  • Acute Coronary Syndrome

Sponsors & Collaborators

  • Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department

    lead OTHER

Principal Investigators

  • Sergey Morozov · Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-29
Primary Completion
2023-04-06
Completion
2025-06-01

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04862026 on ClinicalTrials.gov