Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04862026
Status:
SUSPENDED
Last Update Posted:
2023-04-10
First Post:
2021-04-14
Brief Title:
Telemonitoring of Patients With Acute Coronary Syndrome
Sponsor:
Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
Organization:
Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
Study Overview
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
Status:
SUSPENDED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Technical difficulties of the developer
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TeleCor
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
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 I210 I211 I212 I213 I214 I219
Unstable angina I200 Recurrent myocardial infarction I220 I221 I228 I229
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
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 I210 I211 I212 I213 I214 I219
Unstable angina I200 Recurrent myocardial infarction I220 I221 I228 I229
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None