Arrhythmias, Cardiac, Atrial Fibrillation, Heart Diseases, Syncope, Tachycardia
Conditions
Keywords
Cardiac Monitor
Brief summary
The objective of the study is to evaluate the efficacy of monitoring after discharge of patients with high-risk acute coronary syndrome.
Detailed description
The objective of the study is to evaluate the efficacy of monitoring after discharge of patients with high-risk acute coronary syndrome.
Interventions
DEVICEBiomonitor-2 and Kardia mobile
Implantable cardiac monitor and Smart-phone based electrocardiogram recording
OTHERNo Intervention
No intervention
Sponsors
Fundación EPIC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Advanced conduction abnormalities and significant ST shifts (> 1 mm) in the EKG | 1 year | Detection rates of advanced conduction abnormalities and significant ST shifts (\> 1 mm) in the EKG. |
| Atrial fibrilation (AF / atrial flutter) | 1 year | Detection rates for atrial fibrilation (AF / atrial flutter) during the follow up. |
| Ventricular arrhythmia in the electrocardiogram (EKG) | 1 year | Detection rates of ventricular arrhythmia in the electrocardiogram (EKG) during the follow up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | 1 year | MACCE rates defined as cardiovascular and cerebrovascular events during the follow up. |
| Re-hospitalization | 1 year | Number of Re-hospitalization during the follow up. |
| Correlation of primary outcomes between Biomonitor-2 versus Kardia Mobile | 1 year | Correlation of primary outcomes between Biomonitor-2 versus Kardia Mobile during the follow up. |
Countries
Spain
Outcome results
None listed