Evaluation of Ambulatory Monitoring of Patients After High-risk Acute Coronary Syndrome Using Two Different Systems: Biomonitor-2 and Kardia Mobile
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Fundación EPIC
- Enrollment
- 169
- Locations
- 1
- Primary Endpoint
- Atrial fibrilation (AF / atrial flutter)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
- •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.
Outcomes
Primary Outcomes
Atrial fibrilation (AF / atrial flutter)
Time Frame: 1 year
Detection rates for atrial fibrilation (AF / atrial flutter) during the follow up.
Ventricular arrhythmia in the electrocardiogram (EKG)
Time Frame: 1 year
Detection rates of ventricular arrhythmia in the electrocardiogram (EKG) during the follow up.
Advanced conduction abnormalities and significant ST shifts (> 1 mm) in the EKG
Time Frame: 1 year
Detection rates of advanced conduction abnormalities and significant ST shifts (\> 1 mm) in the EKG.
Secondary Outcomes
- Correlation of primary outcomes between Biomonitor-2 versus Kardia Mobile(1 year)
- Re-hospitalization(1 year)
- Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)(1 year)