Remote Monitoring System for Patients, Who Had Myocardial Infarction

NCT04424368 | Unknown

• 1 other identifier: 191119
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction; Adherence, Patient

Keywords

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

Outcome Measures

Primary Outcomes (5)

• cardiovascular mortality

  the number of deaths from cardiovascular causes

  12 months

• acute myocardial infarction

  incidence of acute myocardial infarction

  12 months

• cerebral stroke

  incidence of cerebral stroke

  12 months

• revascularization

  frequency of repeated revascularization of coronary arteries

  12 months

• hospitalization

  frequency of hospitalization about the progression of coronary heart disease

  12 months

Study Arms (2)

The remote monitoring system

EXPERIMENTAL

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.

Device: The 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.

Interventions

The remote monitoring system DEVICE

Usage of remote monitoring system

The remote monitoring system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The high level of adherence to treatment
• Signed informed agreement

You may not qualify if:

• Active cancer or remission period less than 5 years;
• Absolute contradictions to the prescription of beta-adrenergic blocking agents, angiotensin converting enzyme inhibitors, statins, antiaggregants.
• Mental illnesses.
• Alcohol and drug abuse
• Patient's noncompliance, according to the researchers

Sponsors & Collaborators

• Ryazan State Medical University: lead

Study Sites (1)

RyazSMU

Ryazan, Russia

Location

MeSH Terms

Conditions

Myocardial Infarction; Patient Compliance

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Kristina Pereverzeva, MD, PhD

  RyazSMU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 9, 2020
• Study Start: October 3, 2018
• Primary Completion: December 3, 2021
• Study Completion: December 31, 2021
• Last Updated: November 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)