Status:

SUSPENDED

Telemonitoring of Patients With Acute Coronary Syndrome

Lead Sponsor:

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

Conditions:

Acute Coronary Syndrome

Eligibility:

All Genders

18-80 years

Brief 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 ...

Detailed Description

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: 1. Improving the effect...

Eligibility Criteria

Inclusion

  • 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)

Exclusion

  • 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.

Key Trial Info

Start Date :

April 29 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

June 1 2025

Estimated Enrollment :

950 Patients enrolled

Trial Details

Trial ID

NCT04862026

Start Date

April 29 2021

End Date

June 1 2025

Last Update

April 10 2023

Active Locations (1)

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1

City Clinical Hospital No. 13 of the Moscow City Health Department

Moscow, Russia, 115280