Remote Monitoring System for Patients, Who Had Myocardial Infarction

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04424368
• Other study ID #: 191119
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 3, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2021
• Source: Ryazan State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: December 31, 2021
• Est. primary completion date: December 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Patient
• Infarction
• Myocardial Infarction

Intervention

Device:
• The remote monitoring system
Usage of remote monitoring system

Locations

Country	Name	City	State
Russian Federation	RyazSMU	Ryazan'

Sponsors (1)

Lead Sponsor	Collaborator
Ryazan State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiovascular mortality	the number of deaths from cardiovascular causes	12 months
Primary	acute myocardial infarction	incidence of acute myocardial infarction	12 months
Primary	cerebral stroke	incidence of cerebral stroke	12 months
Primary	revascularization	frequency of repeated revascularization of coronary arteries	12 months
Primary	hospitalization	frequency of hospitalization about the progression of coronary heart disease	12 months