Telemonitoring of Patients With Acute Coronary Syndrome

NCT04862026 | Suspended

• 1 other identifier: 2021-1
• Study Type: observational
• Target: 950
• Locations: 1 country
• Sites: 1

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 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

Keywords

Acute coronary syndrome, telemonitoring

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Moscow, 115280, Russia

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Sergey Morozov

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 27, 2021
• Study Start: April 29, 2021
• Primary Completion: April 6, 2023
• Study Completion: June 1, 2025
• Last Updated: April 10, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)