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

Not Applicable

Completed

• Conditions: Syncope; Tachycardia; Atrial Fibrillation; Heart Diseases; Arrhythmias, Cardiac
• Interventions: Other: No Intervention; Device: Biomonitor-2 and Kardia mobile

• Registration Number: NCT03940066
• Lead Sponsor: Fundación EPIC

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.

Study Timeline

• Study First Submitted: 2019-05-05
• Study First Submitted QC: 2019-05-05
• Study First Posted: 2019-05-07
• Study Start: 2019-11-12
• Status Verified: 2023-04
• Primary Completion: 2024-04-08
• Study Completion: 2024-06-01
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care	No Intervention	-
Monitoring group	Biomonitor-2 and Kardia mobile	-

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
Re-hospitalization	1 year	Number of Re-hospitalization during the follow up.
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)	1 year	MACCE rates defined as cardiovascular and cerebrovascular events during the follow up.

Trial Locations

Locations (1)

Hospital Universitario Marques de Valdecilla; 🇪🇸 Santander, Spain