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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03494751
Other study ID # 5391/17
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2019
Est. completion date July 1, 2020

Study information

Verified date April 2018
Source Instituto de Cardiologia do Rio Grande do Sul
Contact silvia goldmeier, doctor
Phone 5132354127
Email sgoldmeier@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 358
Est. completion date July 1, 2020
Est. primary completion date September 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients over 18 years

- patients post-acute myocardial infarctium

Exclusion Criteria:

- patients with neurological disease

- patients with congenital heart disease

Study Design


Intervention

Device:
Heart monitor
Use of heart monitor device in the patients after acute myocardium infarct.
No heart monitor
Standard monitoring by nurses.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Instituto de Cardiologia do Rio Grande do Sul

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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