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

April 12, 2023 updated by: Fundación EPIC
The objective of the study is to evaluate the efficacy of monitoring after discharge of patients with high-risk acute coronary syndrome.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

169

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Santander, Spain, 39008
        • Hospital Universitario Marques de Valdecilla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Standard Care
Other: No Intervention
No intervention
Other: Monitoring group
Device: Biomonitor-2 and Kardia mobile
Implantable cardiac monitor and Smart-phone based electrocardiogram recording

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrial fibrilation (AF / atrial flutter)
Time Frame: 1 year
Detection rates for atrial fibrilation (AF / atrial flutter) during the follow up.
1 year
Ventricular arrhythmia in the electrocardiogram (EKG)
Time Frame: 1 year
Detection rates of ventricular arrhythmia in the electrocardiogram (EKG) during the follow up.
1 year
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time Frame: 1 year
MACCE rates defined as cardiovascular and cerebrovascular events during the follow up.
1 year
Re-hospitalization
Time Frame: 1 year
Number of Re-hospitalization during the follow up.
1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación EPIC

Investigators

  • Principal Investigator: Felipe Rodríguez Entem, MD, PhD, Hospital Universitario Marques de Valdecilla
  • Principal Investigator: José M De la Torre Hernández, MD, PhD, Hospital Universitario Marques de Valdecilla

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2019

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

May 5, 2019

First Submitted That Met QC Criteria

May 5, 2019

First Posted (Actual)

May 7, 2019

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Monitor- ACS - EPIC 013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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