Remote Monitoring System for Patients, Who Had Myocardial Infarction

NCT04424368 — Not applicable, Unknown, 250 participants, Ryazan State Medical University

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Creation and Evaluation of the Effectiveness of the Remote Monitoring System for Patients, Who Had Myocardial Infarction

Registry	NCT04424368
Status	Unknown
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, supportive care
Enrollment	250 (Actual)
Sponsor	Ryazan State Medical University (Other)
Conditions	Myocardial Infarction, Adherence, Patient
Interventions	The remote monitoring system (Device)
Dates	start 2018-10-03, primary completion 2021-12-03 (estimated), completion 2021-12-31 (estimated), first posted 2020-06-09, last updated 2021-11-09
Locations	1 site in Russia

-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.

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+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).

+Arms and interventions

Arm	Type	Interventions	Description
The remote monitoring system	Experimental	Device: The 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 and using remote monitoring system.
Clinical recommendations	No intervention		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.

The remote monitoring system (Device): Usage of remote monitoring system

+Outcome measures

Primary outcomes

cardiovascular mortality [12 months]: the number of deaths from cardiovascular causes
acute myocardial infarction [12 months]: incidence of acute myocardial infarction
cerebral stroke [12 months]: incidence of cerebral stroke
revascularization [12 months]: frequency of repeated revascularization of coronary arteries
hospitalization [12 months]: frequency of hospitalization about the progression of coronary heart disease

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
RyazSMU	Ryazan	Russia

+Investigators

Kristina Pereverzeva, MD, PhD, Principal investigator, RyazSMU