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

NCT03940066 | Completed DMC

• 1 other identifier: Monitor- ACS - EPIC 013
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Cardiac Monitor

Outcome Measures

Primary Outcomes (3)

• Atrial fibrilation (AF / atrial flutter)

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

  1 year

• Ventricular arrhythmia in the electrocardiogram (EKG)

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

  1 year

• 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.

  1 year

Secondary Outcomes (3)

• Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)

  1 year

• Re-hospitalization

  1 year

• Correlation of primary outcomes between Biomonitor-2 versus Kardia Mobile

  1 year

Study Arms (2)

Monitoring group

OTHER

Device: Biomonitor-2 and Kardia mobile

Standard Care

OTHER

Other: No Intervention

Interventions

Biomonitor-2 and Kardia mobile DEVICE

Implantable cardiac monitor and Smart-phone based electrocardiogram recording

Monitoring group

No Intervention OTHER

No intervention

Standard Care

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación EPIC: lead

Study Sites (1)

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

Location

Related Publications (6)

• 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.

  PMID: 25586123 BACKGROUND

• 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.

  PMID: 20805624 BACKGROUND

• 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.

  PMID: 15187054 BACKGROUND

• 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.

  PMID: 25343586 BACKGROUND

• 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.

  PMID: 29760234 BACKGROUND

• De La Torre Hernandez JM, Exposito V, Gonzalez Enriquez S, Rodriguez Entem F, Margarida A, Garcia Camarero T, Veiga G, Sainz Laso F, Lee DH, Gil Ongay A, Barrera S, Catoya S, Garilleti C, Hernandez R, Obregon C, Olalla JJ. Evaluation of ambulatory electrocardiographic monitoring of patients after high-risk acute coronary syndrome: the MONITOR ACS-Epic 13 randomized trial. Front Cardiovasc Med. 2025 Aug 18;12:1646175. doi: 10.3389/fcvm.2025.1646175. eCollection 2025.

  PMID: 40901364 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Cardiac Conduction System Disease

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2019
• First Posted: May 7, 2019
• Study Start: November 12, 2019
• Primary Completion: April 8, 2024
• Study Completion: June 1, 2024
• Last Updated: April 6, 2025

Record last verified: 2023-04

Locations

ES (1)