BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction (BIO-GUARD-MI)
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| ClinicalTrials.gov Identifier: NCT02341534 |
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Recruitment Status :
Completed
First Posted : January 19, 2015
Last Update Posted : January 21, 2022
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Sponsor:
Biotronik SE & Co. KG
Collaborators:
IHF GmbH - Institut für Herzinfarktforschung
Qmed Consulting A/S
Information provided by (Responsible Party):
Biotronik SE & Co. KG
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Myocardial Infarction Myocardial Infarction, Acute Myocardial Infarction Old | Device: BioMonitor | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 802 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (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. |
| Primary Purpose: | Diagnostic |
| Official Title: | BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction |
| Actual Study Start Date : | August 7, 2015 |
| Actual Primary Completion Date : | November 3, 2021 |
| Actual Study Completion Date : | November 3, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Heart Attack
| Arm | Intervention/treatment |
|---|---|
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BioMonitor arm
BioMonitor group (implantation with investigational device + transfer of information via Home Monitoring)
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Device: BioMonitor
Patients will be implanted with the BioMonitor + Home Monitoring feature |
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No Intervention: Control arm
Control group (standard of care)
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Primary Outcome Measures :
- Time to first major adverse cardiac event (MACE) [ Time Frame: From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 4.0 years. ]
MACE 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 :
- All-cause mortality [ Time Frame: From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 4.0 years. ]The occurrence of death for any cause will be recorded and analyzed.
- Time to death from any cause or heart transplantation [ Time Frame: From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 4.0 years. ]Assessment of the time from randomization to death for any reason or heart transplantation during the clinical investigation.
- Time to cardiovascular death or heart transplantation [ Time Frame: From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 4.0 years. ]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 to first worsening of the patient status due to heart failure requiring hospitalization or urgent visit [ Time Frame: From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 4.0 years. ]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 to first hospitalization resulting from an arrhythmia [ Time Frame: From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 4.0 years. ]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 to first hospitalization resulting from acute coronary syndrome [ Time Frame: From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 4.0 years. ]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 to first hospitalization resulting from stroke [ Time Frame: From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 4.0 years. ]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 to first hospitalization resulting from major bleeding [ Time Frame: From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 4.0 years. ]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 to first hospitalization resulting from systemic embolism [ Time Frame: From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 4.0 years. ]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 to first arrhythmia [ Time Frame: From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 4.0 years. ]Assessment of the time from randomization to first arrhythmia.
- Type of initiated therapies [ Time Frame: From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 4.0 years. ]Evaluation of the diagnoses and consequent type of therapies based on ICM-detected arrhythmias.
- Time to first therapy [ Time Frame: From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 4.0 years. ]Assessment of the time from randomization to first therapy. In this context therapy is the attempted remediation of the patient's regular heartbeat.
- Quality of Life (QoL) [ Time Frame: From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 4.0 years. ]A further secondary endpoint is the assessment of the patient's quality of life. The patient's quality of life will be recorded during the regular telephone contacts using the WHO-5 Wellbeing Index.
Other Outcome Measures:
- EQ-5D-5L [ Time Frame: From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 4.0 years. ]In addition, the EQ-5D-5L questionnaire will be administered during the telephone contacts to estimate utility values at different time points for an economic evaluation.
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| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341534
Locations
Show 59 study locations
Sponsors and Collaborators
Biotronik SE & Co. KG
IHF GmbH - Institut für Herzinfarktforschung
Qmed Consulting A/S
Investigators
| Study Chair: | Christian Jons, Doctor | Rigshospitalet; Denmark; Copenhagen | |
| Principal Investigator: | Steffen Behrens, Professor | Vivantes Humboldt Klinikum, Germany, Berlin | |
| Study Director: | Poul Erik Bloch Thomsen, Professor | Aalborg University Hospital, Denmark, Aalborg | |
| Principal Investigator: | Peter Sogaard, Professor | Aalborg University Hospital, Denmark, Aalborg |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Biotronik SE & Co. KG |
| ClinicalTrials.gov Identifier: | NCT02341534 |
| Other Study ID Numbers: |
HS058 Preserved Ejection Fraction ( Other Identifier: BIOTRONIK ) Implantable Cardiac Device ( Other Identifier: BIOTRONIK ) Loop Recorder ( Other Identifier: BIOTRONIK ) ICM ( Other Identifier: BIOTRONIK ) |
| First Posted: | January 19, 2015 Key Record Dates |
| Last Update Posted: | January 21, 2022 |
| Last Verified: | January 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
Additional relevant MeSH terms:
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Myocardial Infarction Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |