Atrial FibrillationMonitor- ACSNCT03940066
Evaluation of Ambulatory Monitoring of Patients After High-risk Acute Coronary Syndrome Using Two Different Systems: Biomonitor-2 and Kardia Mobile
A study testing Biomonitor-2 and Kardia mobile in people with Atrial Fibrillation and Syncope, run by Fundación EPIC at 1 site in Spain.
Trial summary
The objective of the study is to evaluate the efficacy of monitoring after discharge of patients with high-risk acute coronary syndrome. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation, Syncope, Tachycardia
- What is being tested?
- Biomonitor-2 and Kardia mobile
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteSpain
- Study dates
- 12 Nov 2019to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Atrial Fibrillation, Syncope, Tachycardia, Arrhythmias, Cardiac, Heart Diseases
- Being tested
- Biomonitor-2 and Kardia mobile, No Intervention
- Keywords
- Cardiac Monitor
- Medical subject headings
- Atrial Fibrillation, Syncope, Tachycardia, Arrhythmias, Cardiac, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomonitor-2 and Kardia mobileDevice
Implantable cardiac monitor and Smart-phone based electrocardiogram recording
No InterventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Monitoring group | Other | Not described Receives: Device: Biomonitor-2 and Kardia mobile |
| Standard Care | Other | Not described Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrilation (AF / atrial flutter)
Detection rates for atrial fibrilation (AF / atrial flutter) during the follow up.
Measured: 1 year
Ventricular arrhythmia in the electrocardiogram (EKG)
Detection rates of ventricular arrhythmia in the electrocardiogram (EKG) during the follow up.
Measured: 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.
Measured: 1 year
Secondary outcomes (3)
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
MACCE rates defined as cardiovascular and cerebrovascular events during the follow up.
Measured: 1 year
Re-hospitalization
Number of Re-hospitalization during the follow up.
Measured: 1 year
Correlation of primary outcomes between Biomonitor-2 versus Kardia Mobile
Correlation of primary outcomes between Biomonitor-2 versus Kardia Mobile during the follow up.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start12 Nov 2019
- Primary completion8 Apr 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación EPIC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Felipe Rodríguez Entem, MD, PhD, Principal investigator, Hospital Universitario Marqués de ValdecillaJosé M De la Torre Hernández, MD, PhD, Principal investigator, Hospital Universitario Marqués de Valdecilla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940066
- Sponsor's protocol ID
- Monitor- ACS - EPIC 013
- Acronym
- Monitor- ACS
- Status last verified
- Apr 2023
- First submitted
- 5 May 2019
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 25586123Bhatt 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 20805624Eagle 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 15187054Chua 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 25343586Halcox 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 29760234De 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.
PubMed 40901364
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ambulatory Monitoring of Patients After High-risk Acute Coronary Syndrome Using Two Different Systems: Biomonitor-2 and Kardia Mobile
- ClinicalTrials.gov ID
- NCT03940066
- Acronym / sponsor ID
- Monitor- ACS / Monitor- ACS - EPIC 013
- Conditions
- Atrial Fibrillation, Syncope, Tachycardia, Arrhythmias, Cardiac, Heart Diseases
- Keywords
- Cardiac Monitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Fundación EPICUniversity, hospital or other
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 8 Apr 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 7 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monitoring group | Other | Device: Biomonitor-2 and Kardia mobile |
| Standard Care | Other | Other: No Intervention |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomonitor-2 and Kardia mobileImplantable cardiac monitor and Smart-phone based electrocardiogram recording | Device | Monitoring group |
| No InterventionNo intervention | Other | Standard Care |
Primary outcome
Atrial fibrilation (AF / atrial flutter)
Time frame: 1 year
Detection rates for atrial fibrilation (AF / atrial flutter) during the follow up.
Ventricular arrhythmia in the electrocardiogram (EKG)
Time frame: 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
Time frame: 1 year
Detection rates of advanced conduction abnormalities and significant ST shifts (> 1 mm) in the EKG.
3 secondary outcomes
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time frame: 1 year
Re-hospitalization
Time frame: 1 year
Correlation of primary outcomes between Biomonitor-2 versus Kardia Mobile
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Background: PubMed 25586123Jernberg 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.
- Background: PubMed 20805624Bhatt 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.
- Background: PubMed 15187054Eagle 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.
- Background: PubMed 25343586Chua 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.
- Background: PubMed 29760234Halcox 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.
- Derived from this study: PubMed 40901364De 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.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biomonitor-2 and Kardia mobile in people with Atrial Fibrillation and Syncope, run by Fundación EPIC at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrilation (AF / atrial flutter) (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03940066, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.