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

Atrial Fibrillation Clinical Trial

— Monitor- ACS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03940066
• Other study ID #: Monitor- ACS - EPIC 013
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 12, 2019
• Est. completion date: June 1, 2023

Study information

• Verified date: April 2023
• Source: Fundación EPIC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 169
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Arrhythmias, Cardiac
• Atrial Fibrillation
• Heart Diseases
• Syncope
• Tachycardia

Intervention

Device:
• Biomonitor-2 and Kardia mobile
Implantable cardiac monitor and Smart-phone based electrocardiogram recording

Other:
• No Intervention
No intervention

Locations

Country	Name	City	State
Spain	Hospital Universitario Marques de Valdecilla	Santander

Sponsors (1)

Lead Sponsor	Collaborator
Fundación EPIC

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial fibrilation (AF / atrial flutter)	Detection rates for atrial fibrilation (AF / atrial flutter) during the follow up.	1 year
Primary	Ventricular arrhythmia in the electrocardiogram (EKG)	Detection rates of ventricular arrhythmia in the electrocardiogram (EKG) during the follow up.	1 year
Primary	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	Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)	MACCE rates defined as cardiovascular and cerebrovascular events during the follow up.	1 year
Secondary	Re-hospitalization	Number of Re-hospitalization during the follow up.	1 year
Secondary	Correlation of primary outcomes between Biomonitor-2 versus Kardia Mobile	Correlation of primary outcomes between Biomonitor-2 versus Kardia Mobile during the follow up.	1 year