TeleCor: Telemonitoring of Patients With Acute Coronary Syndrome

Sponsor
Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department (Other)
Overall Status
Recruiting
CT.gov ID
NCT04862026
Collaborator
(none)
950
Enrollment
1
Location
13.1
Anticipated Duration (Months)
72.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase

    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 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.

    2. Creation of a unified methodology for remote observation using telemedicine technologies in patients with ACS.

    3. 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.

    Inclusion criteria:
    • 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 criteria:
    • 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.

    Exclusion criteria:
    • 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 the observation of the need for surgical (not counting myocardial revascularization) or chemotherapy treatment;

    • Severe injuries (including craniocerebral), impeding observation according to the study protocol.

    Primary endpoint (combined):
      1. Death from cardiovascular causes and / or b) Repeated hospitalizations for SS pathology
    1. The number of episodes requiring emergency or urgent care without hospitalization (calls to the emergency room for complaints from the cardiovascular system)

    Secondary endpoints:
    1. Quality of life according to the HeartQol questionnaire.

    2. 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.

    3. Tolerance to physical activity (any increase in walking distance according to 6MWT, VEM according to indications).

    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:

    • Outpatient observation with connection to the telemonitoring program - 475 ID

    • Outpatient monitoring without connecting to the telemonitoring program - 475 ID Each ID number will be placed in an individual envelope and sealed. In accordance with the agreement on the number of patients to be included in the study, each specific healthcare facility will be provided with sealed envelopes in the required volume, taking into account the equal distribution of volunteers into 2 groups. After opening the envelope, the patient is assigned this ID, and the patient is assigned to the corresponding ID group.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    950 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    The Influence of Telemonitoring on the Development of Clinical Events and Improving the Quality of Life of Patients With Acute Coronary Syndrome (TeleCor)
    Actual Study Start Date :
    Apr 29, 2021
    Anticipated Primary Completion Date :
    Dec 31, 2021
    Anticipated Study Completion Date :
    Jun 1, 2022

    Arms and Interventions

    ArmIntervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Death or rehospitalizations Primary endpoint A [Upon completion, up to 6 months]

      Death from cardiovascular causes and / or rehospitalizations for cardiovascular pathology

    2. Emergency or urgent care without hospitalization [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)

    Secondary Outcome Measures

    1. Quality of life according to the HeartQol questionnaire. [Upon completion, up to 6 months]

      Health-related quality of life, symptoms, and functional status make up patient-reported outcomes

    2. Commitment to outpatient monitoring [Upon completion, up to 6 months]

      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.

    3. Tolerance to physical activity [Upon completion, up to 6 months]

      Tolerance to physical activity (any increase in walking distance according to 6MWT, VEM according to indications).

    4. Decrease in body weight [Upon completion, up to 6 months]

      Any decrease in body weight (weight, BMI) any decrease in waist circumference.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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 Criteria:
    • 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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1City Clinical Hospital No. 13 of the Moscow City Health DepartmentMoscowRussian Federation115280

    Sponsors and Collaborators

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

    Investigators

    • Study Director: Sergey Morozov, Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
    ClinicalTrials.gov Identifier:
    NCT04862026
    Other Study ID Numbers:
    • 2021-1
    First Posted:
    Apr 27, 2021
    Last Update Posted:
    May 5, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 5, 2021