Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Heart Monitoring Device After Acute Myocardium Infarction (Monitor)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03494751
Recruitment Status : Unknown
Verified April 2018 by Instituto de Cardiologia do Rio Grande do Sul.
Recruitment status was:  Not yet recruiting
First Posted : April 11, 2018
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Instituto de Cardiologia do Rio Grande do Sul

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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Device: Heart monitor Device: No heart monitor Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 358 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Heart Monitoring Device After Acute Myocardium Infarction
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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 Name: 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 Name: No heart monitor device




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • patients with neurological disease
  • patients with congenital heart disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494751


Contacts
Layout table for location contacts
Contact: silvia goldmeier, doctor 5132354127 sgoldmeier@gmail.com
Contact: manoela vargas, student 5132354127 vargas.manoela@gmail.com

Sponsors and Collaborators
Instituto de Cardiologia do Rio Grande do Sul
Investigators
Layout table for investigator information
Study Chair: silvia goldmeier Instituto de Cardiologia do Rio Grande do Sul
Layout table for additonal information
Responsible Party: Instituto de Cardiologia do Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT03494751    
Other Study ID Numbers: 5391/17
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Instituto de Cardiologia do Rio Grande do Sul:
Monitoring
Myocardial infarction
Clinical trial
Additional relevant MeSH terms:
Layout table for MeSH terms
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases