MedDataX Logo

Remote Monitoring System for Patients, Who Had Myocardial Infarction

NCT ID: NCT04424368

Last Updated: 2021-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-03

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myocardial Infarction Adherence, Patient

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

myocardial infraction the high level of potential adherence to treatment polymorphism of genes remote monitoring, prognosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

The remote monitoring system

Intervention Type DEVICE

Usage of remote monitoring system

Clinical recommendations

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

The remote monitoring system

Usage of remote monitoring system

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ryazan State Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kristina Pereverzeva, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

RyazSMU

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

RyazSMU

Ryazan, , Russia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Russia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

191119

Identifier Type: -

Identifier Source: org_study_id