Back to resultsEvaluation of Ambulatory Monitoring of Patients After High-risk Acute Coronary Syndrome Using Two Different Systems: Biomonitor-2 and Kardia Mobile (Monitor- ACS)
Primary Purpose
Atrial Fibrillation, Syncope, Tachycardia
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Biomonitor-2 and Kardia mobile
No Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring Cardiac Monitor
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.
Sites / Locations
- Hospital Universitario Marques de Valdecilla
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Monitoring group
Standard Care
Arm Description
Outcomes
Primary Outcome Measures
Atrial fibrilation (AF / atrial flutter)
Detection rates for atrial fibrilation (AF / atrial flutter) during the follow up.
Ventricular arrhythmia in the electrocardiogram (EKG)
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
Detection rates of advanced conduction abnormalities and significant ST shifts (> 1 mm) in the EKG.
Secondary Outcome Measures
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
MACCE rates defined as cardiovascular and cerebrovascular events during the follow up.
Re-hospitalization
Number of Re-hospitalization during the follow up.
Correlation of primary outcomes between Biomonitor-2 versus Kardia Mobile
Correlation of primary outcomes between Biomonitor-2 versus Kardia Mobile during the follow up.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03940066
Brief Title
Evaluation of Ambulatory Monitoring of Patients After High-risk Acute Coronary Syndrome Using Two Different Systems: Biomonitor-2 and Kardia Mobile
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 12, 2019 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación EPIC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Syncope, Tachycardia, Arrhythmias, Cardiac, Heart Diseases
Keywords
Cardiac Monitor
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
169 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Monitoring group
Arm Type
Other
Arm Title
Standard Care
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Biomonitor-2 and Kardia mobile
Intervention Description
Implantable cardiac monitor and Smart-phone based electrocardiogram recording
Intervention Type
Other
Intervention Name(s)
No Intervention
Intervention Description
No intervention
Primary Outcome Measure Information:
Title
Atrial fibrilation (AF / atrial flutter)
Description
Detection rates for atrial fibrilation (AF / atrial flutter) during the follow up.
Time Frame
1 year
Title
Ventricular arrhythmia in the electrocardiogram (EKG)
Description
Detection rates of ventricular arrhythmia in the electrocardiogram (EKG) during the follow up.
Time Frame
1 year
Title
Advanced conduction abnormalities and significant ST shifts (> 1 mm) in the EKG
Description
Detection rates of advanced conduction abnormalities and significant ST shifts (> 1 mm) in the EKG.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Description
MACCE rates defined as cardiovascular and cerebrovascular events during the follow up.
Time Frame
1 year
Title
Re-hospitalization
Description
Number of Re-hospitalization during the follow up.
Time Frame
1 year
Title
Correlation of primary outcomes between Biomonitor-2 versus Kardia Mobile
Description
Correlation of primary outcomes between Biomonitor-2 versus Kardia Mobile during the follow up.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe Rodríguez Entem, MD, PhD
Organizational Affiliation
Hospital Universitario Marqués de Valdecilla
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
José M De la Torre Hernández, MD, PhD
Organizational Affiliation
Hospital Universitario Marqués de Valdecilla
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
25586123
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.
Results Reference
background
PubMed Identifier
20805624
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.
Results Reference
background
PubMed Identifier
15187054
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.
Results Reference
background
PubMed Identifier
25343586
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.
Results Reference
background
PubMed Identifier
29760234
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.
Results Reference
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Evaluation of Ambulatory Monitoring of Patients After High-risk Acute Coronary Syndrome Using Two Different Systems: Biomonitor-2 and Kardia Mobile
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