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CompletedNCT03940066Monitor- ACSUpdated Apr 6, 2025

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

An interventional study of Biomonitor-2 and Kardia mobile and No Intervention in Atrial Fibrillation, Syncope and Tachycardia, sponsored by Fundación EPIC. Completed at 1 site in Spain. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-04-06.

Sponsored by Fundación EPIC · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
169
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Atrial Fibrillation
  • Syncope
  • Tachycardia
  • Arrhythmias, Cardiac
  • Heart Diseases

Keywords

  • Cardiac Monitor
03

In context

Syncope

226 studies on the registry are indexed under Syncope; 45 are open to participants now.

This study's enrollment of 169 is above the median of 79 across 126 interventional studies indexed under Syncope.

Browse Syncope studies →

Lead sponsor

Fundación EPIC is the lead sponsor of 48 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
169 participants (actual)

Study arms

  • Other
    Monitoring group

    Device: Biomonitor-2 and Kardia mobile

  • Other
    Standard Care

    Other: No Intervention

Interventions

  • DeviceBiomonitor-2 and Kardia mobile

    Implantable cardiac monitor and Smart-phone based electrocardiogram recording

  • OtherNo Intervention

    No intervention

06

What researchers measure

Primary outcomes

  1. Atrial fibrilation (AF / atrial flutter)

    Detection rates for atrial fibrilation (AF / atrial flutter) during the follow up.

    Time frame: 1 year

  2. Ventricular arrhythmia in the electrocardiogram (EKG)

    Detection rates of ventricular arrhythmia in the electrocardiogram (EKG) during the follow up.

    Time frame: 1 year

  3. Advanced conduction abnormalities and significant ST shifts (> 1 mm) in the EKG

    Detection rates of advanced conduction abnormalities and significant ST shifts (\> 1 mm) in the EKG.

    Time frame: 1 year

Secondary outcomes

  1. Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)

    MACCE rates defined as cardiovascular and cerebrovascular events during the follow up.

    Time frame: 1 year

  2. Re-hospitalization

    Number of Re-hospitalization during the follow up.

    Time frame: 1 year

  3. Correlation of primary outcomes between Biomonitor-2 versus Kardia Mobile

    Correlation of primary outcomes between Biomonitor-2 versus Kardia Mobile during the follow up.

    Time frame: 1 year

07

Study locations

1 site
  • Hospital Universitario Marques de Valdecilla
    Santander, 39008, Spain
08

References and documents

Publications

  • Jernberg T, Hasvold P, Henriksson M, Hjelm H, Thuresson M, Janzon M. Cardiovascular risk in post-myocardial infarction patients: nationwide real world data demonstrate the importance of a long-term perspective. Eur Heart J. 2015 May 14;36(19):1163-70. doi: 10.1093/eurheartj/ehu505. Epub 2015 Jan 13. PubMed 25586123 ↗
  • Bhatt DL, Eagle KA, Ohman EM, Hirsch AT, Goto S, Mahoney EM, Wilson PW, Alberts MJ, D'Agostino R, Liau CS, Mas JL, Rother J, Smith SC Jr, Salette G, Contant CF, Massaro JM, Steg PG; REACH Registry Investigators. Comparative determinants of 4-year cardiovascular event rates in stable outpatients at risk of or with atherothrombosis. JAMA. 2010 Sep 22;304(12):1350-7. doi: 10.1001/jama.2010.1322. Epub 2010 Aug 30. PubMed 20805624 ↗
  • Eagle KA, Lim MJ, Dabbous OH, Pieper KS, Goldberg RJ, Van de Werf F, Goodman SG, Granger CB, Steg PG, Gore JM, Budaj A, Avezum A, Flather MD, Fox KA; GRACE Investigators. A validated prediction model for all forms of acute coronary syndrome: estimating the risk of 6-month postdischarge death in an international registry. JAMA. 2004 Jun 9;291(22):2727-33. doi: 10.1001/jama.291.22.2727. PubMed 15187054 ↗
  • Chua SK, Lo HM, Chiu CZ, Shyu KG. Use of CHADS(2) and CHA(2)DS(2)-VASc scores to predict subsequent myocardial infarction, stroke, and death in patients with acute coronary syndrome: data from Taiwan acute coronary syndrome full spectrum registry. PLoS One. 2014 Oct 24;9(10):e111167. doi: 10.1371/journal.pone.0111167. eCollection 2014. PubMed 25343586 ↗
  • Halcox JPJ, Wareham K. Response by Halcox and Wareham to Letter Regarding Article, "Assessment of Remote Heart Rhythm Sampling Using the AliveCor Heart Monitor to Screen for Atrial Fibrillation: The REHEARSE-AF Study". Circulation. 2018 May 15;137(20):2193-2194. doi: 10.1161/CIRCULATIONAHA.118.033773. No abstract available. PubMed 29760234 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03940066
Lead sponsor
Fundación EPIC
Responsible party
Sponsor
First posted
May 7, 2019
Start date
Nov 12, 2019
Primary completion
Apr 8, 2024
Completion
Jun 1, 2024
Last update
Apr 6, 2025

Study contacts

Felipe Rodríguez Entem, MD, PhD
principal investigator · Hospital Universitario Marqués de Valdecilla
José M De la Torre Hernández, MD, PhD
principal investigator · Hospital Universitario Marqués de Valdecilla

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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