Clinical trial NCT04424368: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Myocardial Infarction
Adherence, Patient
Keywords: myocardial infraction
the high level of potential adherence to treatment
polymorphism of genes
remote monitoring, prognosis
Lead sponsor: Ryazan State Medical University
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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

Primary outcomes:
measure: cardiovascular mortality
timeFrame: 12 months
measure: acute myocardial infarction
timeFrame: 12 months
measure: cerebral stroke
timeFrame: 12 months
measure: revascularization
timeFrame: 12 months
measure: hospitalization
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ryazan'
country: Russian Federation
facility: RyazSMU
Study officials:
affiliation: RyazSMU
name: Kristina Pereverzeva, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: