Heart Monitoring Device After Acute Myocardium Infarction (Monitor)

April 4, 2019 updated by: Instituto de Cardiologia do Rio Grande do Sul
Verify the effectiveness of a Heart Monitor in preventing events in patients over 18 years after acute myocardial infarction in a clinical unit. Patients with neurological disease or congenital heart disease we excluded from the study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Heart Monitor can detect early intercurrences. Objective: To verify the effectiveness of a Heart Monitoring system in preventing events in patients after acute myocardial infarction. Methodology: This is a randomized clinical trial to be developed in a clinical unit and will include patients over 18 years , post-acute myocardial infarction who were transferred from the ICU emergency or hemodynamic to clinical unit. Patients with neurological disease or congenital heart disease will be excluded from the study.

Study Type

Interventional

Enrollment (Anticipated)

358

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients over 18 years
  • patients post-acute myocardial infarctium

Exclusion Criteria:

  • patients with neurological disease
  • patients with congenital heart disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Heart Monitor
We used the device (heart monitor) in the patients with myocardial infarction.
Device: Heart monitor
Use of heart monitor device in the patients after acute myocardium infarct.
Other Names:
  • Heart monitor device
ACTIVE_COMPARATOR: No Heart Monitor
No heart monitor device in the patients with myocardial infarction (control).
Device: No heart monitor
Standard monitoring by nurses.
Other Names:
  • No heart monitor device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rhythm monitoring
Time Frame: One year
Evaluating the effectiveness of a heart monitoring device in the prevention and detection of events in patients after acute myocardial infarction
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Cardiologia do Rio Grande do Sul

Investigators

  • Study Chair: silvia goldmeier, Instituto de Cardiologia do Rio Grande do Sul

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2019

Primary Completion (ANTICIPATED)

September 1, 2019

Study Completion (ANTICIPATED)

July 1, 2020

Study Registration Dates

First Submitted

January 22, 2018

First Submitted That Met QC Criteria

April 4, 2018

First Posted (ACTUAL)

April 11, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2019

Last Update Submitted That Met QC Criteria

April 4, 2019

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5391/17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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