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Remote Monitoring System for Patients, Who Had Myocardial Infarction

Primary Purpose

Myocardial Infarction, Adherence, Patient

Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
The remote monitoring system
Sponsored by
Ryazan State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Myocardial Infarction focused on measuring myocardial infraction, the high level of potential adherence to treatment, polymorphism of genes, remote monitoring, prognosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. A significant diagnosis of myocardial infraction, confirmed by the level of biomarkers of myocardial necrosis in blood examination (troponin, creatine kinase-MV), electrocardiographic criteria, typical clinical presentation.
  2. The high level of adherence to treatment
  3. Signed informed agreement

Exclusion Criteria:

  1. Active cancer or remission period less than 5 years;
  2. Absolute contradictions to the prescription of beta-adrenergic blocking agents, angiotensin converting enzyme inhibitors, statins, antiaggregants.
  3. Mental illnesses.
  4. Alcohol and drug abuse
  5. Patient's noncompliance, according to the researchers

Sites / Locations

  • RyazSMU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

The remote monitoring system

Clinical recommendations

Arm Description

A group of patients, who had myocardial infraction and who has a very high risk of developing an unfavorable prognosis, which are followed up in the local outpatient department according to existing clinical recommendations and using remote monitoring system.

A group of patients, who had myocardial infraction and who has a very high risk of developing an unfavorable prognosis, which are followed up in the local outpatient department according to existing clinical recommendations.

Outcomes

Primary Outcome Measures

cardiovascular mortality
the number of deaths from cardiovascular causes
acute myocardial infarction
incidence of acute myocardial infarction
cerebral stroke
incidence of cerebral stroke
revascularization
frequency of repeated revascularization of coronary arteries
hospitalization
frequency of hospitalization about the progression of coronary heart disease

Secondary Outcome Measures

Full Information

First Posted
June 5, 2020
Last Updated
November 6, 2021
Sponsor
Ryazan State Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04424368
Brief Title
Remote Monitoring System for Patients, Who Had Myocardial Infarction
Official Title
Creation and Evaluation of the Effectiveness of the Remote Monitoring System for Patients, Who Had Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 3, 2018 (Actual)
Primary Completion Date
December 3, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ryazan State Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
one-centered, open, prospective, non-randomized, controlled clinical study will be aimed at creating remote monitoring system for patients' condition and the development of methodological approaches and its usage for conducting patients, who had myocardial infraction and who has a very high risk of developing an unfavorable outcome.
Detailed Description
The research will involve patients, who had myocardial infraction and who has the high level of potential adherence to treatment, which will be determined by the usage of Russian generic questionnaire for evaluation of compliance to drug therapy. At the end of a 12 month observation with the registration of unfavorable cardiovascular occasions (death from cardiovascular reasons, nonfatal myocardial infraction, cerebral stroke, necessity for repeated revascularization of the coronary arteries) based on the analysis of non-genetic and genetic factors (polymorphism of genes Thr174Met and Met235Thr in gene angiotensinogen, Arg389Gly and Ser49Gly in gene adrenoceptor beta 1, Ser447Ter in gene lipoprotein lipase and Leu28Pro in gene apolipoprotein E, Trp212Ter and G681A in gene cytochrome P450 family 2 subfamily C member 19) factors of unfavorable prognosis will be identified and considering which group of patients requires the use of remote monitoring system will be formed. From one group of patients we will form two comparable groups, one group will use this remote monitoring system and another will not. The effectiveness of the remote monitoring system will be evaluated after 6-month's observation based on the registration of the unfavorable cardiovascular occasions (death from cardiovascular reasons, nonfatal myocardial infraction, cerebral stroke, necessity for repeated revascularization of the coronary arteries, frequency of hospitalizations).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Adherence, Patient
Keywords
myocardial infraction, the high level of potential adherence to treatment, polymorphism of genes, remote monitoring, prognosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The remote monitoring system
Arm Type
Experimental
Arm Description
A group of patients, who had myocardial infraction and who has a very high risk of developing an unfavorable prognosis, which are followed up in the local outpatient department according to existing clinical recommendations and using remote monitoring system.
Arm Title
Clinical recommendations
Arm Type
No Intervention
Arm Description
A group of patients, who had myocardial infraction and who has a very high risk of developing an unfavorable prognosis, which are followed up in the local outpatient department according to existing clinical recommendations.
Intervention Type
Device
Intervention Name(s)
The remote monitoring system
Intervention Description
Usage of remote monitoring system
Primary Outcome Measure Information:
Title
cardiovascular mortality
Description
the number of deaths from cardiovascular causes
Time Frame
12 months
Title
acute myocardial infarction
Description
incidence of acute myocardial infarction
Time Frame
12 months
Title
cerebral stroke
Description
incidence of cerebral stroke
Time Frame
12 months
Title
revascularization
Description
frequency of repeated revascularization of coronary arteries
Time Frame
12 months
Title
hospitalization
Description
frequency of hospitalization about the progression of coronary heart disease
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A significant diagnosis of myocardial infraction, confirmed by the level of biomarkers of myocardial necrosis in blood examination (troponin, creatine kinase-MV), electrocardiographic criteria, typical clinical presentation. The high level of adherence to treatment Signed informed agreement Exclusion Criteria: Active cancer or remission period less than 5 years; Absolute contradictions to the prescription of beta-adrenergic blocking agents, angiotensin converting enzyme inhibitors, statins, antiaggregants. Mental illnesses. Alcohol and drug abuse Patient's noncompliance, according to the researchers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristina Pereverzeva, MD, PhD
Organizational Affiliation
RyazSMU
Official's Role
Principal Investigator
Facility Information:
Facility Name
RyazSMU
City
Ryazan'
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

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Remote Monitoring System for Patients, Who Had Myocardial Infarction

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