Adherence, Patient, Myocardial Infarction
Conditions
Keywords
myocardial infraction, the high level of potential adherence to treatment, polymorphism of genes, remote monitoring, prognosis
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).
Interventions
DEVICEThe remote monitoring system
Usage of remote monitoring system
Sponsors
Ryazan State Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Russia
Outcome results
None listed