Clinical Trial Details
— Status: Suspended
Administrative data
| NCT number |
NCT04862026 |
| Other study ID # |
2021-1 |
| Secondary ID |
|
| Status |
Suspended |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 29, 2021 |
| Est. completion date |
June 1, 2025 |
Study information
| Verified date |
April 2023 |
| Source |
Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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. a) Death from cardiovascular causes and / or b) Repeated hospitalizations for SS
pathology
2. 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.
