NCT03494751

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
358

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 11, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2018

Enrollment Period

4 months

First QC Date

January 22, 2018

Last Update Submit

April 4, 2019

Conditions

Acute Myocardial Infarction

Keywords

MonitoringMyocardial infarctionClinical trial

Outcome Measures

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

    One year

Study Arms (2)

Heart Monitor

EXPERIMENTAL

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

Device: Heart monitor

No Heart Monitor

ACTIVE COMPARATOR

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

Device: No heart monitor

Interventions

Heart monitorDEVICE

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

Also known as: Heart monitor device
Heart Monitor
No heart monitorDEVICE

Standard monitoring by nurses.

Also known as: No heart monitor device
No Heart Monitor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • patients with neurological disease
  • patients with congenital heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • silvia goldmeier

    Instituto de Cardiologia do Rio Grande do Sul

    STUDY CHAIR

Central Study Contacts

silvia goldmeier, doctor

CONTACT

5132354127sgoldmeier@gmail.com

manoela vargas, student

CONTACT

5132354127vargas.manoela@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2018

First Posted

April 11, 2018

Study Start

May 1, 2019

Primary Completion

September 1, 2019

Study Completion

July 1, 2020

Last Updated

April 8, 2019

Record last verified: 2018-04