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Status unknownNCT03494751MonitorUpdated Apr 8, 2019

Heart Monitoring Device After Acute Myocardium Infarction

An interventional study of Heart monitor and No heart monitor in Acute Myocardial Infarction, sponsored by Instituto de Cardiologia do Rio Grande do Sul. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-08.

Sponsored by Instituto de Cardiologia do Rio Grande do Sul · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
358
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Acute Myocardial Infarction

Keywords

  • Monitoring
  • Myocardial infarction
  • Clinical trial
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patients with neurological disease
  • patients with congenital heart disease
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
358 participants (estimated)

Study arms

  • Experimental
    Heart Monitor

    We used the device (heart monitor) in the patients with myocardial infarction.

    Device: Heart monitor

  • Active comparator
    No Heart Monitor

    No heart monitor device in the patients with myocardial infarction (control).

    Device: No heart monitor

Interventions

  • DeviceHeart monitor

    Use of heart monitor device in the patients after acute myocardium infarct.

    Also known as: Heart monitor device

  • DeviceNo heart monitor

    Standard monitoring by nurses.

    Also known as: No heart monitor device

05

What researchers measure

Primary outcomes

  1. Heart rhythm monitoring

    Evaluating the effectiveness of a heart monitoring device in the prevention and detection of events in patients after acute myocardial infarction

    Time frame: One year

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03494751
Lead sponsor
Instituto de Cardiologia do Rio Grande do Sul
Responsible party
Sponsor
First posted
Apr 11, 2018
Start date
May 1, 2019 (estimated)
Primary completion
Sep 1, 2019 (estimated)
Completion
Jul 1, 2020 (estimated)
Last update
Apr 8, 2019

Study contacts

silvia goldmeier, doctor
Contact
sgoldmeier@gmail.com
5132354127
manoela vargas, student
Contact
vargas.manoela@gmail.com
5132354127
silvia goldmeier
study chair · Instituto de Cardiologia do Rio Grande do Sul

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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