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出境医 / 临床实验 / Evaluation of Ambulatory Monitoring of Patients After High-risk Acute Coronary Syndrome Using Two Different Systems: Biomonitor-2 and Kardia Mobile (Monitor- ACS)

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

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Syncope Tachycardia Arrhythmias, Cardiac Heart Diseases Device: Biomonitor-2 and Kardia mobile Other: No Intervention Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Ambulatory Monitoring of Patients After High-risk Acute Coronary Syndrome Using Two Different Systems: Biomonitor-2 and Kardia Mobile
Actual Study Start Date : November 12, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021
Arms and Interventions
Arm Intervention/treatment
Monitoring group Device: Biomonitor-2 and Kardia mobile
Implantable cardiac monitor and Smart-phone based electrocardiogram recording
Standard Care Other: No Intervention
No intervention
Outcome Measures
Primary Outcome Measures :
  1. Atrial fibrilation (AF / atrial flutter) [ Time Frame: 1 year ]
    Detection rates for atrial fibrilation (AF / atrial flutter) during the follow up.

  2. Ventricular arrhythmia in the electrocardiogram (EKG) [ Time Frame: 1 year ]
    Detection rates of ventricular arrhythmia in the electrocardiogram (EKG) during the follow up.

  3. 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.


Secondary Outcome Measures :
  1. Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) [ Time Frame: 1 year ]
    MACCE rates defined as cardiovascular and cerebrovascular events during the follow up.

  2. Re-hospitalization [ Time Frame: 1 year ]
    Number of Re-hospitalization during the follow up.

  3. Correlation of primary outcomes between Biomonitor-2 versus Kardia Mobile [ Time Frame: 1 year ]
    Correlation of primary outcomes between Biomonitor-2 versus Kardia Mobile during the follow up.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
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Contact: José M De la Torre Hernández, MD, PhD +34987876135 jmdelatorre@fundacionepic.org
Contact: Fundación EPIC +34987876135 iepic@fundacionepic.org

Locations
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Spain
Hospital Universitario Marques de Valdecilla Recruiting
Santander, Spain, 39008
Sponsors and Collaborators
Fundación EPIC
Investigators
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Principal Investigator: 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
Tracking Information
First Submitted Date  ICMJE May 5, 2019
First Posted Date  ICMJE May 7, 2019
Last Update Posted Date June 8, 2021
Actual Study Start Date  ICMJE November 12, 2019
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2019)
  • Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) [ Time Frame: 1 year ]
    MACCE rates defined as cardiovascular and cerebrovascular events during the follow up.
  • Re-hospitalization [ Time Frame: 1 year ]
    Number of Re-hospitalization during the follow up.
  • Correlation of primary outcomes between Biomonitor-2 versus Kardia Mobile [ Time Frame: 1 year ]
    Correlation of primary outcomes between Biomonitor-2 versus Kardia Mobile during the follow up.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Ambulatory Monitoring of Patients After High-risk Acute Coronary Syndrome Using Two Different Systems: Biomonitor-2 and Kardia Mobile
Official Title  ICMJE Evaluation of Ambulatory Monitoring of Patients After High-risk Acute Coronary Syndrome Using Two Different Systems: Biomonitor-2 and Kardia Mobile
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Atrial Fibrillation
  • Syncope
  • Tachycardia
  • Arrhythmias, Cardiac
  • Heart Diseases
Intervention  ICMJE
  • Device: Biomonitor-2 and Kardia mobile
    Implantable cardiac monitor and Smart-phone based electrocardiogram recording
  • Other: No Intervention
    No intervention
Study Arms  ICMJE
  • Monitoring group
    Intervention: Device: Biomonitor-2 and Kardia mobile
  • Standard Care
    Intervention: Other: No Intervention
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.
  • Bhatt DL, Eagle KA, Ohman EM, Hirsch AT, Goto S, Mahoney EM, Wilson PW, Alberts MJ, D'Agostino R, Liau CS, Mas JL, Röther 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.
  • 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.
  • Chua SK, Lo HM, Chiu CZ, Shyu KG. Use of CHADS₂ and CHA₂DS₂-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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 5, 2019) 		150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: José M De la Torre Hernández, MD, PhD +34987876135 jmdelatorre@fundacionepic.org
Contact: Fundación EPIC +34987876135 iepic@fundacionepic.org
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03940066
Other Study ID Numbers  ICMJE Monitor- ACS - EPIC 013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fundación EPIC
Study Sponsor  ICMJE Fundación EPIC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: 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
PRS Account Fundación EPIC
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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