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Heart Monitoring Device After Acute Myocardium Infarction (Monitor)

Primary Purpose

Acute Myocardial Infarction

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Heart monitor
No heart monitor
Sponsored by
Instituto de Cardiologia do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Myocardial Infarction focused on measuring Monitoring, Myocardial infarction, Clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • patients with neurological disease
  • patients with congenital heart disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Heart Monitor

    No Heart Monitor

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    January 22, 2018
    Last Updated
    April 4, 2019
    Sponsor
    Instituto de Cardiologia do Rio Grande do Sul
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03494751
    Brief Title
    Heart Monitoring Device After Acute Myocardium Infarction
    Acronym
    Monitor
    Official Title
    Heart Monitoring Device After Acute Myocardium Infarction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2019 (Anticipated)
    Primary Completion Date
    September 1, 2019 (Anticipated)
    Study Completion Date
    July 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Instituto de Cardiologia do Rio Grande do Sul

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Myocardial Infarction
    Keywords
    Monitoring, Myocardial infarction, Clinical trial

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    358 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Heart Monitor
    Arm Type
    Experimental
    Arm Description
    We used the device (heart monitor) in the patients with myocardial infarction.
    Arm Title
    No Heart Monitor
    Arm Type
    Active Comparator
    Arm Description
    No heart monitor device in the patients with myocardial infarction (control).
    Intervention Type
    Device
    Intervention Name(s)
    Heart monitor
    Other Intervention Name(s)
    Heart monitor device
    Intervention Description
    Use of heart monitor device in the patients after acute myocardium infarct.
    Intervention Type
    Device
    Intervention Name(s)
    No heart monitor
    Other Intervention Name(s)
    No heart monitor device
    Intervention Description
    Standard monitoring by nurses.
    Primary Outcome Measure Information:
    Title
    Heart rhythm monitoring
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients over 18 years patients post-acute myocardial infarctium Exclusion Criteria: patients with neurological disease patients with congenital heart disease
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    silvia goldmeier, doctor
    Phone
    5132354127
    Email
    sgoldmeier@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    manoela vargas, student
    Phone
    5132354127
    Email
    vargas.manoela@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    silvia goldmeier
    Organizational Affiliation
    Instituto de Cardiologia do Rio Grande do Sul
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Heart Monitoring Device After Acute Myocardium Infarction

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