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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03940066

Recruitment Status Recruiting

First Posted May 7, 2019

Last update posted November 19, 2019

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:Syncope
    Atrial Fibrillation
    Tachycardia
    Arrhythmias, Cardiac
    Heart Diseases
  • Intervention/Treatment: Device: Biomonitor-2 and Kardia mobile
    Other: No Intervention
  • Phase: N/A
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
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: December 2021
Arms and interventions
Arm Intervention/treatment
Other: Monitoring group
Device: Biomonitor-2 and Kardia mobile
Implantable cardiac monitor and Smart-phone based electrocardiogram recording
Other: 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
  • Ages Eligible for Study: 18 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

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

Contact: Fundación EPIC +34987876135 iepic@fundacionepic.org

Locations

Spain
Hospital Universitario Marques de Valdecilla
Santander

Sponsors and Collaborators

Fundación EPIC

Investigators

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

More Information