Clinical trial NCT03940066: Evaluation of Ambulatory Monitoring of Patients After High-risk Acute Coronary Syndrome Using Two Different Systems: Biomonitor-2 and Kardia Mobile
Official title: Evaluation of Ambulatory Monitoring of Patients After High-risk Acute Coronary Syndrome Using Two Different Systems: Biomonitor-2 and Kardia Mobile
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Syncope
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Keywords: Cardiac Monitor
Lead sponsor: Fundación EPIC
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Atrial fibrilation (AF / atrial flutter)
timeFrame: 1 year
measure: Ventricular arrhythmia in the electrocardiogram (EKG)
timeFrame: 1 year
measure: Advanced conduction abnormalities and significant ST shifts (> 1 mm) in the EKG
timeFrame: 1 year
Secondary outcomes:
measure: Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
timeFrame: 1 year
measure: Re-hospitalization
timeFrame: 1 year
measure: Correlation of primary outcomes between Biomonitor-2 versus Kardia Mobile
timeFrame: 1 year
Other outcomes:
Locations:
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
Study officials:
affiliation: Hospital Universitario Marqués de Valdecilla
name: Felipe Rodríguez Entem, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Marqués de Valdecilla
name: José M De la Torre Hernández, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
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.