N/A
Completed N=790
BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction
Myocardial Infarction · Myocardial Infarction, Acute · Myocardial Infarction Old
Source: ClinicalTrials.gov NCT02341534 ↗
Enrolled (actual)
790
Serious AEs
71.8%
Results posted
Apr 2023
Primary outcomePrimary: Kaplan-Meier Estimate of Percentage of Participants With Major Adverse Cardiac Event (MACE) — 21.6; 24.3 percentage of patients with event — p=0.21
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kaplan-Meier Estimate of Percentage of Participants With Major Adverse Cardiac Event (MACE) |
21.6; 24.3 | 0.21 |
| SECONDARY Kaplan-Meier Estimate of Percentage of Participants With Outcome of Death Due to Any Cause |
6.7; 7.1 | — |
| SECONDARY Kaplan-Meier Estimate of Percentage of Participants With Outcome of Death Due to Any Cause or Heart Transplantation |
6.7; 7.1 | — |
| SECONDARY Kaplan-Meier Estimate of Percentage of Participants With Outcome of Cardiovascular Death or Heart Transplantation |
3.5; 4.7 | — |
| SECONDARY Kaplan-Meier Estimate of Percentage of Participants With Worsening of Heart Failure Requiring Hospitalization or Urgent Visit |
6.0; 5.9 | — |
| SECONDARY Kaplan-Meier Estimate of Percentage of Participants With an Arrhythmia Resulting in Hospitalization |
3.3; 3.4 | — |
| SECONDARY Kaplan-Meier Estimate of Percentage of Participants With Acute Coronary Syndrome Resulting in Hospitalization |
10.6; 15.1 | — |
| SECONDARY Kaplan-Meier Estimate of Percentage of Participants With Stroke Resulting in Hospitalization |
3.6; 3.0 | — |
| SECONDARY Kaplan-Meier Estimate of Percentage of Participants With Major Bleeding Resulting in Hospitalization |
0.6; 1.1 | — |
| SECONDARY Kaplan-Meier Estimate of Percentage of Participants With Systemic Embolism Resulting in Hospitalization |
0.3; 0.7 | — |
| SECONDARY Kaplan-Meier Estimate of Percentage of Participants With an Arrhythmia |
53.6; 10 | — |
| SECONDARY Type of Initiated Therapies |
84; 18; 45; 6; 43; 5 | — |
| SECONDARY Kaplan-Meier Estimate of Percentage of Participants Receiving Therapy After Arrhythmia Diagnosis |
53.6; 10.0 | — |
| SECONDARY Change in World Health Organization Five Well-being Index (WHO-5) From 6 Months to 24 Months. |
0.1; 0.7 | — |
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
Data sourced from ClinicalTrials.gov (NCT02341534). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.