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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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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

  • Clinicaltrials.gov identifier

    NCT03940066

  • Recruitment Status

    Recruiting

  • First Posted

    May 7, 2019

  • Last update posted

    June 8, 2021

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:Atrial Fibrillation
    Syncope
    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 2021
  • 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