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OpenTrials
Completed

NCT Number: NCT03940066

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

The objective of the study is to evaluate the efficacy of monitoring after discharge of patients with high-risk acute coronary syndrome.

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Key information

About this study

The objective of the study is to evaluate the efficacy of monitoring after discharge of patients with high-risk acute coronary syndrome.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biomonitor-2 and Kardia mobile

Device

Implantable cardiac monitor and Smart-phone based electrocardiogram recording

No intervention

Other

No intervention

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Fundación EPIC

Other

Registry information

Acronym: Monitor- ACS

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
May 7, 2019
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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