Evaluation of Ambulatory Monitoring of Patients After High-risk Acute Coronary Syndrome Using Two Different Systems: Biomonitor-2 and Kardia Mobile

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

169 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-12

Study Completion Date

2024-06-01

Brief Summary

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The objective of the study is to evaluate the efficacy of monitoring after discharge of patients with high-risk acute coronary syndrome.

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Detailed Description

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The objective of the study is to evaluate the efficacy of monitoring after discharge of patients with high-risk acute coronary syndrome.

Conditions

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Atrial Fibrillation Syncope Tachycardia Arrhythmias, Cardiac Heart Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Monitoring group

Group Type OTHER

Biomonitor-2 and Kardia mobile

Intervention Type DEVICE

Implantable cardiac monitor and Smart-phone based electrocardiogram recording

Standard Care

Group Type OTHER

No Intervention

Intervention Type OTHER

No intervention

Interventions

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Biomonitor-2 and Kardia mobile

Implantable cardiac monitor and Smart-phone based electrocardiogram recording

Intervention Type DEVICE

No Intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient is able to understand the nature of study and has provided written informed consent.
* Patient with Acute Coronary Syndrome, with or without elevation of the ST segment at the EKG (the last with elevation of troponins).
* Patient with coronariography at the episode of ACS showing severe lesions treated with stent.
* Patient with risk index for 6-month mortality (GRACE score) of more than 118.
* Patient with risk index for stroke (CHA2DS2-VACS score) of more than 2.

Exclusion Criteria

* Patient with history of AF.
* Patient with episodes of AF during admission at the current episode.
* Patient with pacemaker or ICD (implantable cardioverter-defibrillator) previously.
* Patient with indication of pacemaker or ICD in current or short-term phase.
* Patient is participating in another interventional clinical investigation.
* Patient is pregnant or breast feeding.
* Patient´s life-expectancy is less than 24 months.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No