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

Sponsor

Fundación EPIC (Other)

Overall Status

Recruiting

CT.gov ID

NCT03940066

Collaborator

(none)

150

Enrollment

Location

Arms

36.6

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of the study is to evaluate the efficacy of monitoring after discharge of patients with high-risk acute coronary syndrome.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Syncope Tachycardia Arrhythmias, Cardiac Heart Diseases	Device: Biomonitor-2 and Kardia mobile Other: No Intervention	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 12, 2019

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Monitoring group	Device: Biomonitor-2 and Kardia mobile Implantable cardiac monitor and Smart-phone based electrocardiogram recording
Other: Standard Care	Other: No Intervention No intervention

Arm

Intervention/Treatment

Other: Monitoring group

Device: Biomonitor-2 and Kardia mobile

Implantable cardiac monitor and Smart-phone based electrocardiogram recording

Other: Standard Care

Other: No Intervention

No intervention

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Marques de Valdecilla	Santander		Spain	39008

Sponsors and Collaborators

Fundación EPIC

Investigators

Principal Investigator: Felipe Rodríguez Entem, MD, PhD, Hospital Universitario Marqués de Valdecilla
Principal Investigator: José M De la Torre Hernández, MD, PhD, Hospital Universitario Marqués de Valdecilla