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BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction (BIO-GUARD-MI)

Primary Purpose

Myocardial Infarction, Myocardial Infarction, Acute, Myocardial Infarction Old

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
BioMonitor
Sponsored by
Biotronik SE & Co. KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocardial Infarction

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient has a history of MI according to guidelines
  • CHA2DS2-VASc-Score ≥ 4 in men / ≥ 5 in women
  • LVEF > 35 % as estimated within 6 months before enrollment but after conclusion of AMI treatment
  • Patient accepts activation of Home Monitoring®
  • Patient is able to understand the nature of the clinical study and has provided written informed consent

Exclusion Criteria:

  • Patients with hemorrhagic diathesis
  • Permanent oral anticoagulation treatment for atrial fibrillation
  • Indication for chronic renal dialysis
  • Pacemaker or ICD implanted or indication for implantation
  • Parkinson's disease
  • Life expectancy < 1 year
  • Participation in another interventional clinical Investigation
  • Age < 18 years
  • Woman who are pregnant or breast feeding

Sites / Locations

  • Gateway Cardiology
  • St. Louis Heart and Vascular
  • University of Rochester Medical Center
  • Altru Health System
  • Abington Medical Specialists
  • Carolina Heart Specialists
  • Carolina Cardiology Associates
  • Metro Knoxville HMA LLC
  • Lyell McEwin Hospital (LMH)
  • East Metropolitan Health Service Trading AS Royal Perth HOSPITAL
  • The Canberra Hospital
  • Kepler Universitätsklinikum
  • OLV Ziekenhuis Aalst
  • Ziekenhuis Oost Limburg Genk (ZOL Genk)
  • Fakultní nemocnice Olomouc
  • Institute for Clinical and Experimental Medicine (IKEM)
  • Nemocnice České Budějovice
  • Odense University Hospital (OUH)
  • Aalborg Universitetshospitel
  • Rigshospitalet
  • Regionshospitalet Herning
  • Sjaellands Universitets Hospital, Roskilde
  • Regionshospitalet Viborg
  • Århus Universitetshospital
  • CHRU de Tours - Hôpital Trousseau
  • Hôpital Gabriel Montpied, Clermont Ferrand
  • Zentralklinik Bad Berka GmbH
  • Herz- und Gefäß- Klinik GmbH Bad Neustadt
  • Charité Universitätsklinikum - Campus Benjamin Franklin
  • Vivantes Humboldt-Klinikum
  • Vivantes-Krankenhaus Spandau
  • Städtisches Krankenhaus Bielefeld-Mitte
  • Klinikum Coburg
  • Klinikum Fürth
  • SRH Wald-Klinikum Gera GmbH
  • Ernst-Moritz-Arndt-Universität Greifswald
  • Klinikum der Universität Jena
  • Herzzentrum Leipzig GmbH
  • Universitätsklinikum Schleswig-Holstein (UKSH) - Campus Lübeck
  • Johannes Wesling Klinikum Minden
  • Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
  • Universitätsklinikum Würzburg
  • National Hospital of Cardiology
  • Gottsegen György
  • Semmelweis Medical University
  • Hungarian Defence Forces Military Hospital
  • The Debrecen University of Medicine
  • The University of Pécs
  • Pauls Stradins Clinical University Hospital
  • Riga East Clinical University Hospital
  • Onze Lieve Vrouwe Gasthuis Amsterdam (OLVG)
  • Scheperziekenhuis, Treant Zorggroep
  • Klinika i Katedra Chorób Wewn. i Kardiologii
  • National Institute of Cardiology
  • SÚSCCH
  • East-Slovak Cardiology Institute (VUSCH)
  • Hospital del Mar
  • Hospital de la Princesa
  • Hospital Universitario Ramón y Cajal

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

BioMonitor arm

Control arm

Arm Description

BioMonitor group (implantation with investigational device + transfer of information via Home Monitoring)

Control group (standard of care)

Outcomes

Primary Outcome Measures

Kaplan-Meier Estimate of Percentage of Participants With Major Adverse Cardiac Event (MACE)
The primary endpoint is defined as death for cardiovascular reasons or unplanned hospitalization for cardiovascular reasons as per study protocol. The time period with regards to the Time-to-Event Outcome Measures starts with the randomization of the patient. All patients will be assessed for Time-to-Event Outcome Measures until formal study termination is announced or until the individual patient meets a drop out criterion in accordance with the study protocol. The study period is estimated 6 years.

Secondary Outcome Measures

Kaplan-Meier Estimate of Percentage of Participants With Outcome of Death Due to Any Cause
The occurrence of death due to any cause will be recorded and analyzed.
Kaplan-Meier Estimate of Percentage of Participants With Outcome of Death Due to Any Cause or Heart Transplantation
Assessment of the time from randomization to death for any reason or heart transplantation during the clinical investigation.
Kaplan-Meier Estimate of Percentage of Participants With Outcome of Cardiovascular Death or Heart Transplantation
Assessment of the time from randomization to cardiovascular death or heart transplantation during the clinical investigation. A specified endpoint definition will be given by the members of the EAEC and documented in the charter agreement.
Kaplan-Meier Estimate of Percentage of Participants With Worsening of Heart Failure Requiring Hospitalization or Urgent Visit
Assessment of the time from randomization to first hospitalization or urgent visit for worsening of the patient status due to heart failure, or death due to heart failure. A specified endpoint definition will be given by the members of the EAEC and documented in the charter agreement.
Kaplan-Meier Estimate of Percentage of Participants With an Arrhythmia Resulting in Hospitalization
Assessment of the time from randomization to the first hospitalization resulting from an arrhythmia or death resulting from arrhythmia. A specified endpoint definition will be given by the members of the EAEC and documented in the charter agreement.
Kaplan-Meier Estimate of Percentage of Participants With Acute Coronary Syndrome Resulting in Hospitalization
Assessment of the time from randomization to the first hospitalization resulting from acute coronary syndrome or death resulting from acute coronary syndrome. A specified endpoint definition will be given by the members of the EAEC and documented in the charter agreement.
Kaplan-Meier Estimate of Percentage of Participants With Stroke Resulting in Hospitalization
Assessment of the time from randomization to the first hospitalization resulting from stroke or death resulting from stroke. A specified endpoint definition will be given by the members of the EAEC and documented in the charter agreement.
Kaplan-Meier Estimate of Percentage of Participants With Major Bleeding Resulting in Hospitalization
Assessment of the time from randomization to the first hospitalization resulting from major bleeding or death resulting from major bleeding. A specified endpoint definition will be given by the members of the EAEC and documented in the charter agreement.
Kaplan-Meier Estimate of Percentage of Participants With Systemic Embolism Resulting in Hospitalization
Assessment of the time from randomization to the first hospitalization resulting from systemic embolism or death resulting from systemic embolism. A specified endpoint definition will be given by the members of the EAEC and documented in the charter agreement.
Kaplan-Meier Estimate of Percentage of Participants With an Arrhythmia
Assessment of the time from randomization to first arrhythmia.
Type of Initiated Therapies
Post-hoc categorical summary of most frequent therapies initiated after detection of arrhythmias.
Kaplan-Meier Estimate of Percentage of Participants Receiving Therapy After Arrhythmia Diagnosis
Assessment of the time from randomization to first therapy. In this context therapy is the attempted remediation of the patient's regular heartbeat.
Change in World Health Organization Five Well-being Index (WHO-5) From 6 Months to 24 Months.
A further secondary endpoint is the assessment of the patient's well-being. The patient's well-being will be recorded during the regular telephone contacts using the WHO-5 Well-being Index. The scale reaches from 0 (worst status) to 100 (best possible status).

Full Information

First Posted
December 12, 2014
Last Updated
March 20, 2023
Sponsor
Biotronik SE & Co. KG
Collaborators
IHF GmbH - Institut für Herzinfarktforschung, Qmed Consulting A/S
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1. Study Identification

Unique Protocol Identification Number
NCT02341534
Brief Title
BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction
Acronym
BIO-GUARD-MI
Official Title
BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 7, 2015 (Actual)
Primary Completion Date
November 3, 2021 (Actual)
Study Completion Date
November 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik SE & Co. KG
Collaborators
IHF GmbH - Institut für Herzinfarktforschung, Qmed Consulting A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The BIO|GUARD-MI study investigates whether continuous arrhythmia monitoring and the consequent treatment after detected arrhythmias in patients after myocardial infarction with preserved cardiac function, but other risk factors, decreases the risk of major adverse cardiac events.
Detailed Description
Patients randomized to the BioMonitor arm will receive an implantable cardiac monitor (ICM; BioMonitor) with remote monitoring function (Home Monitoring®). If the device detects and reports an arrhythmia, patients will be appropriately examined and treated. Patients randomized to the control arm will receive best proven treatment, but no implantable cardiac monitor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Myocardial Infarction, Acute, Myocardial Infarction Old

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
An independent Endpoint Committee was installed to evaluate all reported cardiovascular and serious AEs. The information provided to the Committee did not contain information about the group assigment of the patients.
Allocation
Randomized
Enrollment
802 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BioMonitor arm
Arm Type
Other
Arm Description
BioMonitor group (implantation with investigational device + transfer of information via Home Monitoring)
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Control group (standard of care)
Intervention Type
Device
Intervention Name(s)
BioMonitor
Intervention Description
Patients will be implanted with the BioMonitor + Home Monitoring feature
Primary Outcome Measure Information:
Title
Kaplan-Meier Estimate of Percentage of Participants With Major Adverse Cardiac Event (MACE)
Description
The primary endpoint is defined as death for cardiovascular reasons or unplanned hospitalization for cardiovascular reasons as per study protocol. The time period with regards to the Time-to-Event Outcome Measures starts with the randomization of the patient. All patients will be assessed for Time-to-Event Outcome Measures until formal study termination is announced or until the individual patient meets a drop out criterion in accordance with the study protocol. The study period is estimated 6 years.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Kaplan-Meier Estimate of Percentage of Participants With Outcome of Death Due to Any Cause
Description
The occurrence of death due to any cause will be recorded and analyzed.
Time Frame
2 years
Title
Kaplan-Meier Estimate of Percentage of Participants With Outcome of Death Due to Any Cause or Heart Transplantation
Description
Assessment of the time from randomization to death for any reason or heart transplantation during the clinical investigation.
Time Frame
2 years
Title
Kaplan-Meier Estimate of Percentage of Participants With Outcome of Cardiovascular Death or Heart Transplantation
Description
Assessment of the time from randomization to cardiovascular death or heart transplantation during the clinical investigation. A specified endpoint definition will be given by the members of the EAEC and documented in the charter agreement.
Time Frame
2 years
Title
Kaplan-Meier Estimate of Percentage of Participants With Worsening of Heart Failure Requiring Hospitalization or Urgent Visit
Description
Assessment of the time from randomization to first hospitalization or urgent visit for worsening of the patient status due to heart failure, or death due to heart failure. A specified endpoint definition will be given by the members of the EAEC and documented in the charter agreement.
Time Frame
2 years
Title
Kaplan-Meier Estimate of Percentage of Participants With an Arrhythmia Resulting in Hospitalization
Description
Assessment of the time from randomization to the first hospitalization resulting from an arrhythmia or death resulting from arrhythmia. A specified endpoint definition will be given by the members of the EAEC and documented in the charter agreement.
Time Frame
2 years
Title
Kaplan-Meier Estimate of Percentage of Participants With Acute Coronary Syndrome Resulting in Hospitalization
Description
Assessment of the time from randomization to the first hospitalization resulting from acute coronary syndrome or death resulting from acute coronary syndrome. A specified endpoint definition will be given by the members of the EAEC and documented in the charter agreement.
Time Frame
2 years
Title
Kaplan-Meier Estimate of Percentage of Participants With Stroke Resulting in Hospitalization
Description
Assessment of the time from randomization to the first hospitalization resulting from stroke or death resulting from stroke. A specified endpoint definition will be given by the members of the EAEC and documented in the charter agreement.
Time Frame
2 years
Title
Kaplan-Meier Estimate of Percentage of Participants With Major Bleeding Resulting in Hospitalization
Description
Assessment of the time from randomization to the first hospitalization resulting from major bleeding or death resulting from major bleeding. A specified endpoint definition will be given by the members of the EAEC and documented in the charter agreement.
Time Frame
2 years
Title
Kaplan-Meier Estimate of Percentage of Participants With Systemic Embolism Resulting in Hospitalization
Description
Assessment of the time from randomization to the first hospitalization resulting from systemic embolism or death resulting from systemic embolism. A specified endpoint definition will be given by the members of the EAEC and documented in the charter agreement.
Time Frame
2 years
Title
Kaplan-Meier Estimate of Percentage of Participants With an Arrhythmia
Description
Assessment of the time from randomization to first arrhythmia.
Time Frame
2 years
Title
Type of Initiated Therapies
Description
Post-hoc categorical summary of most frequent therapies initiated after detection of arrhythmias.
Time Frame
All data are collected for the period from randomization until official study end or drop-out, for all enrolled patients, up to 6 years.
Title
Kaplan-Meier Estimate of Percentage of Participants Receiving Therapy After Arrhythmia Diagnosis
Description
Assessment of the time from randomization to first therapy. In this context therapy is the attempted remediation of the patient's regular heartbeat.
Time Frame
2 years
Title
Change in World Health Organization Five Well-being Index (WHO-5) From 6 Months to 24 Months.
Description
A further secondary endpoint is the assessment of the patient's well-being. The patient's well-being will be recorded during the regular telephone contacts using the WHO-5 Well-being Index. The scale reaches from 0 (worst status) to 100 (best possible status).
Time Frame
We report the intraindividual change from 6-months to 24-months. All data are collected for the period from randomization until official study end or drop-out, for all enrolled patients.
Other Pre-specified Outcome Measures:
Title
Mean Value of EQ-5D-5L
Description
The EQ-5D-5L questionnaire was administered during the telephone contacts to estimate utility values at different time points for an economic evaluation. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The scale reaches from 0 (worst status) to 100 (best possible status).
Time Frame
From Baseline measurement to 60 months. All data are collected for the period from randomization until official study end or drop-out, for all enrolled patients.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient has a history of MI according to guidelines CHA2DS2-VASc-Score ≥ 4 in men / ≥ 5 in women LVEF > 35 % as estimated within 6 months before enrollment but after conclusion of AMI treatment Patient accepts activation of Home Monitoring® Patient is able to understand the nature of the clinical study and has provided written informed consent Exclusion Criteria: Patients with hemorrhagic diathesis Permanent oral anticoagulation treatment for atrial fibrillation Indication for chronic renal dialysis Pacemaker or ICD implanted or indication for implantation Parkinson's disease Life expectancy < 1 year Participation in another interventional clinical Investigation Age < 18 years Woman who are pregnant or breast feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Jons, Doctor
Organizational Affiliation
Rigshospitalet; Denmark; Copenhagen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Steffen Behrens, Professor
Organizational Affiliation
Vivantes Humboldt Klinikum, Germany, Berlin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Poul Erik Bloch Thomsen, Professor
Organizational Affiliation
Aalborg University Hospital, Denmark, Aalborg
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Peter Sogaard, Professor
Organizational Affiliation
Aalborg University Hospital, Denmark, Aalborg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gateway Cardiology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
St. Louis Heart and Vascular
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Altru Health System
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58201
Country
United States
Facility Name
Abington Medical Specialists
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Carolina Heart Specialists
City
Lancaster
State/Province
South Carolina
ZIP/Postal Code
29720
Country
United States
Facility Name
Carolina Cardiology Associates
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Facility Name
Metro Knoxville HMA LLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37934
Country
United States
Facility Name
Lyell McEwin Hospital (LMH)
City
Elizabeth Vale
State/Province
South Australia
ZIP/Postal Code
5112
Country
Australia
Facility Name
East Metropolitan Health Service Trading AS Royal Perth HOSPITAL
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
The Canberra Hospital
City
Canberra
ZIP/Postal Code
2605
Country
Australia
Facility Name
Kepler Universitätsklinikum
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4020
Country
Austria
Facility Name
OLV Ziekenhuis Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Ziekenhuis Oost Limburg Genk (ZOL Genk)
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Fakultní nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Facility Name
Institute for Clinical and Experimental Medicine (IKEM)
City
Praha
ZIP/Postal Code
14021
Country
Czechia
Facility Name
Nemocnice České Budějovice
City
České Budějovice
ZIP/Postal Code
37001
Country
Czechia
Facility Name
Odense University Hospital (OUH)
City
Odense
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Aalborg Universitetshospitel
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Regionshospitalet Herning
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Sjaellands Universitets Hospital, Roskilde
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Regionshospitalet Viborg
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
Facility Name
Århus Universitetshospital
City
Århus N
ZIP/Postal Code
8200-DK
Country
Denmark
Facility Name
CHRU de Tours - Hôpital Trousseau
City
Chambray-lès-Tours
ZIP/Postal Code
37170
Country
France
Facility Name
Hôpital Gabriel Montpied, Clermont Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
BP69-63003
Country
France
Facility Name
Zentralklinik Bad Berka GmbH
City
Bad Berka
ZIP/Postal Code
99437
Country
Germany
Facility Name
Herz- und Gefäß- Klinik GmbH Bad Neustadt
City
Bad Neustadt a.d. Saale
ZIP/Postal Code
97616
Country
Germany
Facility Name
Charité Universitätsklinikum - Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Vivantes Humboldt-Klinikum
City
Berlin
ZIP/Postal Code
13509
Country
Germany
Facility Name
Vivantes-Krankenhaus Spandau
City
Berlin
ZIP/Postal Code
13585
Country
Germany
Facility Name
Städtisches Krankenhaus Bielefeld-Mitte
City
Bielefeld
ZIP/Postal Code
33604
Country
Germany
Facility Name
Klinikum Coburg
City
Coburg
ZIP/Postal Code
96450
Country
Germany
Facility Name
Klinikum Fürth
City
Fürth
ZIP/Postal Code
90766
Country
Germany
Facility Name
SRH Wald-Klinikum Gera GmbH
City
Gera
ZIP/Postal Code
07548
Country
Germany
Facility Name
Ernst-Moritz-Arndt-Universität Greifswald
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Klinikum der Universität Jena
City
Jena
ZIP/Postal Code
7743
Country
Germany
Facility Name
Herzzentrum Leipzig GmbH
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein (UKSH) - Campus Lübeck
City
Lübeck
ZIP/Postal Code
23562
Country
Germany
Facility Name
Johannes Wesling Klinikum Minden
City
Minden
ZIP/Postal Code
32429
Country
Germany
Facility Name
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
City
Villingen-Schwenningen
ZIP/Postal Code
78052
Country
Germany
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
National Hospital of Cardiology
City
Balatonfüred
ZIP/Postal Code
8231
Country
Hungary
Facility Name
Gottsegen György
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
Facility Name
Semmelweis Medical University
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Hungarian Defence Forces Military Hospital
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
The Debrecen University of Medicine
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
The University of Pécs
City
Pécs
ZIP/Postal Code
H-7624
Country
Hungary
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Riga East Clinical University Hospital
City
Riga
ZIP/Postal Code
1038
Country
Latvia
Facility Name
Onze Lieve Vrouwe Gasthuis Amsterdam (OLVG)
City
Amsterdam
ZIP/Postal Code
1090
Country
Netherlands
Facility Name
Scheperziekenhuis, Treant Zorggroep
City
Emmen
ZIP/Postal Code
7824AA
Country
Netherlands
Facility Name
Klinika i Katedra Chorób Wewn. i Kardiologii
City
Warszawa
ZIP/Postal Code
02 097
Country
Poland
Facility Name
National Institute of Cardiology
City
Warszawa
ZIP/Postal Code
02 097
Country
Poland
Facility Name
SÚSCCH
City
Banska Bystrica
ZIP/Postal Code
974 01
Country
Slovakia
Facility Name
East-Slovak Cardiology Institute (VUSCH)
City
Košice
ZIP/Postal Code
040 11
Country
Slovakia
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital de la Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
31511057
Citation
Jons C, Sogaard P, Behrens S, Schrader J, Mrosk S, Bloch Thomsen PE. The clinical effect of arrhythmia monitoring after myocardial infarction (BIO-GUARD|MI):study protocol for a randomized controlled trial. Trials. 2019 Sep 11;20(1):563. doi: 10.1186/s13063-019-3644-5.
Results Reference
derived

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BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction

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