Evaluation of Ambulatory Monitoring of Patients After High-risk Acute Coronary Syndrome Using Two… (NCT03940066) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Ambulatory Monitoring of Patients After High-risk Acute Coronary Syndrome Using Two Different Systems: Biomonitor-2 and Kardia Mobile
Spain169 participantsStarted 2019-11-12
Plain-language summary
The objective of the study is to evaluate the efficacy of monitoring after discharge of patients with high-risk acute coronary syndrome.
Who can participate
Age range18 Years – 85 Years
SexALL
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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.
What they're measuring
1
Atrial fibrilation (AF / atrial flutter)
Timeframe: 1 year
2
Ventricular arrhythmia in the electrocardiogram (EKG)
Timeframe: 1 year
3
Advanced conduction abnormalities and significant ST shifts (> 1 mm) in the EKG