ClinicalTrials.Veeva

Menu

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

F

Fundación EPIC

Status

Completed

Conditions

Syncope
Atrial Fibrillation
Tachycardia
Arrhythmias, Cardiac
Heart Diseases

Treatments

Device: Biomonitor-2 and Kardia mobile
Other: No Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT03940066
Monitor- ACS - EPIC 013

Details and patient eligibility

About

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

Full description

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

Enrollment

169 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

169 participants in 2 patient groups

Monitoring group
Other group
Treatment:
Device: Biomonitor-2 and Kardia mobile
Standard Care
Other group
Treatment:
Other: No Intervention

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems