Heart Monitoring Device After Acute Myocardium Infarction | NCT03494751

Studies
Heart Monitoring Device After Acute Myocardium Infarction

NCT03494751

Sponsor

Instituto de Cardiologia do Rio Grande do Sul

Status

Unknown status

Last Update Posted

Apr 8, 2019Actual

Enrollment

358Estimated

Phase

Not Applicable

Conditions

Acute Myocardial Infarction

Interventions

Heart monitor
No heart monitor

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2019Estimated

Primary Completion Date

Sep 1, 2019Estimated

Completion Date

Jul 1, 2020Estimated

First Submitted Date

Jan 22, 2018

First Submission Date that Met QC Criteria

Apr 4, 2018

First Posted Date

Apr 11, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2019

Last Update Posted Date

Apr 8, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

358Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Heart monitor	Device	Use of heart monitor device in the patients after acute myocardium infarct.	Heart Monitor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients over 18 years
patients post-acute myocardial infarctium

Exclusion Criteria:

patients with neurological disease
patients with congenital heart disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
silvia goldmeier, doctor	Contact	5132354127		sgoldmeier@gmail.com
manoela vargas, student	Contact	5132354127		vargas.manoela@gmail.com

Overall Officials

Name	Affiliation	Role
silvia goldmeier	Instituto de Cardiologia do Rio Grande do Sul	Study Chair

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009203	Myocardial Infarction

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided