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

Study Overview
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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.

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.

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

Conditions
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Atrial Fibrillation, Syncope, Tachycardia, Arrhythmias, Cardiac, Heart Diseases

Intervention / Treatment
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* Device: Biomonitor-2 and Kardia mobile
* Other: No Intervention


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Monitoring group<br> | Device: Biomonitor-2 and Kardia mobile<br>* Implantable cardiac monitor and Smart-phone based electrocardiogram recording<br>|
| Other: Standard Care<br> | Other: No Intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrilation (AF / atrial flutter) | Detection rates for atrial fibrilation (AF / atrial flutter) during the follow up. | 1 year | 
| Ventricular arrhythmia in the electrocardiogram (EKG) | Detection rates of ventricular arrhythmia in the electrocardiogram (EKG) during the follow up. | 1 year | 
| Advanced conduction abnormalities and significant ST shifts (> 1 mm) in the EKG | Detection rates of advanced conduction abnormalities and significant ST shifts (> 1 mm) in the EKG. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | MACCE rates defined as cardiovascular and cerebrovascular events during the follow up. | 1 year | 
| Re-hospitalization | Number of Re-hospitalization during the follow up. | 1 year | 
| Correlation of primary outcomes between Biomonitor-2 versus Kardia Mobile | Correlation of primary outcomes between Biomonitor-2 versus Kardia Mobile during the follow up. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Monitor